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EUR-Lex - 52023PC0010 - EN
Document 52023PC0010
Internal procedure
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
COM/2023/10 final
Brussels, 6.1.2023
COM(2023) 10 final
2023/0005(COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
1.CONTEXT OF THE PROPOSAL
•Reasons for and objectives of the proposal
Regulation (EU) 2017/745 (MDR) 1 and Regulation (EU) 2017/746 (IVDR) 2 of the European Parliament and of the Council establish a reinforced regulatory framework for medical devices and in vitro diagnostic medical devices. Their objectives are a high level of protection of health for patients and users and the smooth functioning of the internal market for these products. To achieve these objectives and, in light of issues identified with the previous regulatory framework, the Regulations set out a more robust system of conformity assessment to ensure the quality, safety, and performance of devices placed on the EU market.
The MDR has been applicable since 26 May 2021 3 . The transition period provided for in Article 120(3) will end on 26 May 2024.
The IVDR has been applicable since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transition period, ranging from 26 May 2025 for high risk in vitro diagnostics to 26 May 2027 for lower risk in vitro diagnostics, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions 4 .
Despite considerable progress over the past years, the overall capacity of conformity assessment ('notified') bodies remains insufficient to carry out the tasks required of them. In addition, many manufacturers are not sufficiently prepared to meet the strengthened requirements of the MDR by the end of the transition period. This is threatening the availability of medical devices on the EU market.
At present, 36 notified bodies are designated under Regulation (EU) 2017/745. Further 26 applications for designation as notified body are currently being processed; three of them are at an advanced stage 5 .
In October 2022, notified bodies reported they had received altogether 8,120 applications from manufacturers for certification under the MDR and had issued 1,990 certificates in accordance with the MDR. According to an estimation presented by notified bodies to the Medical Device Coordination Group (MDCG) 6 on 17 November 2022, the number of certificates issued by May 2024 may reach around 7,000 if the current rate of certificate issuance remains the same with no changes to current conditions. Notified bodies estimate that the transition of all Directives' certificates to MDR certificates could possibly be completed by December 2027 7 .
Source: European Commission, based on data provided by 30 notified bodies in October 2022.
This is in stark contrast to 21,376 valid certificates issued under Council Directive 90/385/EEC on active implantable medical devices (AIMDD) 8 and Council Directive 93/42/EEC on medical devices (MDD) 9 that will expire between January 2023 and 26 May 2024. Of those 21,376 certificates, 4,311 certificates will expire in 2023 and 17,095 certificates will expire in the first five months of 2024. Of note, 3,509 certificates issued under the AIMDD or MDD have already expired between May 2021 and December 2022.
Year of expiry
Number of expired/expiring certificates issued under Council Directives 90/385/EEC and 93/42/EEC
2021 (from 26 May)
2024 (until 26 May 2024)
Source: European Commission, based on data provided by notified bodies in 2021 and 2022.
After the expiry of the certificates issued under the Directives and without a valid MDR certificate, manufacturers are no longer allowed to place these medical devices on the EU market. This may cause shortages of medical devices, putting patient safety at risk. It is also likely to have a significant negative impact on innovation and business activity in the medical technology sector within the EU. The situation is exacerbated by the impact of the COVID-19 pandemic on clinical investigations, on-site audits and global supply chains, on which Russia's war of aggression against Ukraine is having a further negative impact.
The overall goal of the proposed amendments is to maintain patients' access to a wide range of medical devices while ensuring the transition to the new framework. The extension will be staggered depending on the risk class of the device, i.e. until December 2027 for devices with a higher risk and until December 2028 for medium and lower risk devices.
This proposal thus aims to extend the current transition period laid down in Article 120 of the MDR, based on certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the MDR will benefit from the additional time. This would give manufacturers and notified bodies more time to conduct the conformity assessment procedures in accordance with the MDR, if those conditions are fulfilled. It also proposes to delete the 'sell-off' deadline in the relevant MDR and IVDR provisions, i.e. the end date for the further making available of devices which are placed on the market before or during the transition period and which are still in the supply chain when the extended transition period is over. This would prevent unnecessary disposal of safe medical devices that are already on the market but not yet with the final user.
The extension of the transition period is complemented by an extension of the validity of certificates issued under the previous Council Directives 90/385/EEC and 93/42/EEC for the devices benefiting from the extended transition period. Also the validity of certificates that have already expired since 26 May 2021 would be extended, subject to certain conditions.
•Consistency with existing policy provisions in the policy area
The proposal is coherent with existing policy provisions as well as on-going non-legislative actions, which will complement the proposed amendment. On 25 August 2022, the MDCG endorsed its position paper MDCG 2022-14 10 . The paper lays out 19 non-legislative actions with a view to enhancing notified body capacity, access to notified bodies and manufacturers' preparedness and thereby support a successful transition to the MDR and IVDR. Several of the actions listed in MDCG 2022-14 have already been implemented, such as a MDCG position paper on hybrid audits 11 , new MDCG guidance on appropriate surveillance 12 , and a revision of MDCG 2019-6, removing obstacles to the employment of qualified personnel by notified bodies 13 .
On 1 December 2022, the Commission adopted two delegated acts deferring the timing of the first complete re-assessment of notified bodies 14 . This is expected to free capacities both for designating authorities and notified bodies.
Work is ongoing to implement the remaining actions listed in MDCG 2022-14, as they remain important also if the transition period is extended.
Further actions to support implementation of the two Regulations are also (co-)funded under the 2022 and 2023 work programmes of the EU4Health Programme 15 .
On 9 December 2022, the MDCG issued its position paper MDCG 2022-18 16 which sets out a uniform approach of competent authorities to applying market surveillance measures to bridge the gap between the expiry of MDD or AIMDD certificates and the issuance of MDR certificates. That approach is meant to be a temporary measure until the legislative changes in this proposal take effect. It contributes to avoiding disruption of supply of medical devices on the EU market. However, having regard to the number of certificates expiring in 2023 and 2024, it is not considered a sustainable solution for addressing the expected bottleneck of expiring certificates by 26 May 2024.
2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
•Legal basis
The proposal is based on Articles 114 and 168(4), point (c), of the Treaty on the Functioning of the European Union (TFEU).
•Subsidiarity
According to the principle of subsidiarity, EU action may only be taken if the aims of the envisaged measure cannot be achieved by Member States alone. The legislation being amended was adopted at EU level in line with the subsidiarity principle and any amendment must be made through an act adopted by the EU legislators. In the case of the current proposal for an amendment, EU action is required to avoid disruption in the supply of devices across the EU, to ensure the smooth functioning of the internal market, and to ensure a high level of health protection for patients and users.
•Proportionality
The proposed EU action is necessary to avert the risk of shortages of medical devices across the EU. The proposed amendments aim to ensure that the intended purpose of the MDR and IVDR can be attained. That purpose is to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which guarantees a high level of protection of public health and patient safety and the smooth functioning of the internal market for these products. The proposal maintains the objective of both Regulations to ensure a high level of safety and performance of devices by enhancing their oversight by notified bodies. It only provides for the necessary additional time to achieve this objective. The proposal is proportionate in that it aims to address the identified issue, i.e. that due to shortage of notified body capacity and insufficient preparedness among manufacturers a large number of existing devices may disappear from the market. Therefore, the proposed amendments to the MDR are limited to allowing a gradual phase-in of the requirements, limited to 'legacy' devices that need notified body involvement in the conformity assessment, without altering the substance of those requirements, and the deletion of the 'sell-off' deadline. The amendment of the IVDR is limited to the deletion of the 'sell-off' deadline in order to be consistent with the proposed change in the MDR. The Commission proposes to differentiate between higher risk devices (i.e. class III and class IIb implantable) and lower risk devices (i.e. other class IIb, class IIa and class Im, Is, Ir 17 ), with shorter transition periods for higher risk devices and longer periods for lower risk ones. This approach aims to balance the available notified body capacity and the level of manufacturers' preparedness with high level of public health protection.
•Choice of the instrument
The proposed act is a Regulation to be adopted by the European Parliament and the Council, given that the acts to be amended are Regulations adopted by the European Parliament and the Council.
3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
Given the urgent nature of this proposal, it is not accompanied by a dedicated impact assessment. An impact assessment was already carried out when preparing the proposals for the MDR and the IVDR and this proposal does not alter the MDR or IVDR in substance and does not impose new obligations on the concerned parties. It primarily aims to amend the transitional provisions, allowing for additional time to transition to the MDR's requirements to avoid shortages. The need to act quickly to ensure certainty ahead of the Regulation's current end of transition period did not allow for a broad public consultation. The Commission therefore collected the necessary input from Member States and stakeholders through targeted exchanges.
The initiative aims to assure that patients throughout Europe have access to safe medical devices. As more and more certificates will expire before the May 2024 deadline, the Commission has committed to adopt a proposal in January 2023. This is backed up by urgent calls from the European Parliament, Member States and stakeholders, namely healthcare professionals, patients, academia, scientific bodies, industry and notified bodies. Input from Member States and stakeholders has been sought through targeted interaction, mainly in the framework of the Medical Device Coordination Group (MDCG) with meetings on 24-25 August, 24-25 October and 17 November 2022, dedicated to capacity and preparedness issues. Following a debate in the European Parliament on 24 November 2022 (oral question O-43/2022 ), the European Parliament's Committee on Environment, Public Health and Food Safety requested an urgent targeted amendment in a letter of 5 December 2022. An exchange of views with Member States took place on 9 December 2022 during the EPSCO Health Council 18 ; almost all Member States took the floor and supported the urgent adoption of a targeted amendment of the MDR and IVDR as suggested by the Commission.
The Commission will continue to closely monitor the developments and the impact of the proposed amendments on the market. It will also consult with the MDCG and stakeholders about the need for complementary actions.
4.BUDGETARY IMPLICATIONS
The proposed action has no budgetary implications.
5.OTHER ELEMENTS
•Detailed explanation of the specific provisions of the proposal
Article 1 contains the proposed amendments to Article 120(2), (3) and (4) and to Articles 122 and 123 of the MDR. Article 2 contains the amendments to Article 110(4) and to Article 112 of the IVDR.
•Article 1(1), point (a), of the proposal – extension of the validity of certificates
This provision amends Article 120(2) MDR. It extends the validity of certificates issued under Council Directives 90/385/EEC or 93/42/EEC that were valid on the day of the MDR's date of application (26 May 2021) and have not been withdrawn by a notified body. The extension is directly applicable, so that notified bodies are not required to change the date on the individual certificates. The length of the extension of the certificate's validity corresponds to the length of the extended transition period laid down in the proposed Article 120(3a) to (3c) of the MDR. As regards certificates that have already expired when the proposed amendment comes into force, the extension would be subject to the condition that, at the moment of the expiry, the manufacturer has signed a contract with a notified body for the conformity assessment of the device in question. Alternatively, if no such contract has been signed at the moment when the certificate expired, a national competent authority may have granted a derogation from the applicable conformity assessment procedure in accordance with Article 59 of the MDR or have required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 97 of the MDR.
•Article 1(1), point (b), of the proposal – extension of the transition period
This provision amends Article 120(3) MDR. Due to the length of the provision, paragraph 3 is replaced by paragraphs 3a to 3g. The transition period is extended from 26 May 2024 until 31 December 2027 for higher risk devices (class III and class IIb implantable devices except certain devices for which the MDR provides exemptions, given that these devices are considered to be based on well established technologies) and until 31 December 2028 for medium and lower risk devices (other class IIb devices and class IIa, class Im, Is and Ir devices).
In the same way as the current Article 120(3) MDR, the extended transition period applies only to 'legacy devices', i.e. those covered by a certificate or declaration of conformity issued under Council Directives 90/385/EEC or 93/42/EEC before 26 May 2021.
Moreover, the application of the extended transition period is subject to several cumulative conditions, which are:
●the devices must continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable. This condition is already part of the current Article 120(3) MDR;
●the devices do not undergo significant changes in the design and intended purpose. This condition is already part of the current Article 120(3) MDR;
●the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health. The concept of "unacceptable risk to health and safety" is set out in Article 94 and 95 of the MDR. No systematic check of the device's safety is required, as devices covered by a certificate issued under the Directives will be under 'appropriate surveillance' by the body that issued the certificate or a notified body designated under the MDR. Where, as part of their market surveillance activities, a competent authority finds that a device presents an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, the transition period ceases to apply for that device;
●no later than 26 May 2024, the manufacturer has put in place a quality management system (QMS) in accordance with Article 10(9) of the MDR. This condition aims to ensure that manufacturers gradually move towards full compliance with the MDR requirements. No specific attestation, i.e. no self-declaration nor verification of the appropriateness of the QMS by a notified body, is required at this stage. However, by submitting an application for conformity assessment to a notified body (see next condition), the manufacturer implicitly confirms that its QMS is in compliance with the MDR;
●no later than 26 May 2024, the manufacturer, or its authorised representative, has lodged a formal application in accordance with Annex VII, Section 4.3, of the MDR for conformity assessment in respect of a 'legacy device' covered by a Directive's certificate or declaration of conformity, or in respect of a device intended to substitute that device under the MDR, and no later than 26 September 2024 the notified body and the manufacturer have signed a written agreement in accordance with Annex VII, Section 4.3, of this Regulation. This condition aims to ensure that only devices that the manufacturer intends to transition to the MDR will benefit from the extended transition period. The extension should, however, also apply to 'legacy devices' that the manufacturer intends to replace by a 'new' device for which it applies for conformity assessment before 26 May 2024. In this way, unnecessary applications for certification of devices that will in any case be phased out and replaced by a new generation of devices will be avoided, whist keeping the existing models available until the end of the transition period.
The devices covered by a certificate issued under the AIMDD or MDD remain subject to 'appropriate surveillance' by the notified body that issued the certificate. Alternatively, the manufacturer can agree with a notified body designated under the MDR that the latter becomes responsible for the surveillance. At the latest by the date when the written agreement between the manufacturer and the notified body for conformity assessment in accordance with the MDR needs to be signed, that notified body would by default become responsible for the appropriate surveillance.
The amendment introduces a transition period until 26 May 2026 also for class III custom-made implantable devices, which are currently not covered by Article 120(3) MDR. While manufacturers of class III implantable custom-made devices are required to comply with all applicable MDR requirements since 26 May 2021, they will now be given more time to obtain certification of their quality management system by a notified body. Also in this case, the transition period only applies if the manufacturer has lodged an application before 26 May 2024 resulting in the signing of a contract with the notified body before 26 September 2024.
•Article 1(1), point (c), of the proposal – deletion of the 'sell-off' deadline in the MDR
This provision deletes the current 'sell-off' date (27 May 2025) in Article 120(4) MDR. Consequently, devices placed on the market before the end of the transition period can be made further available on the market without a legal time restriction.
•Article 1(2) and (3) of the proposal – adaptation of Articles 122 and 123 MDR
This provision adapts Articles 122 and 123 MDR to reflect the extended transition period and the deletion of the 'sell-off' deadline.
•Article 2(1) of the proposal – deletion of the 'sell-off' deadlines in the IVDR
This provision deletes the current 'sell-off' dates (25 May 2025 to 26 May 2028) in Article 110(4) IVDR. Consequently, devices placed on the market before the end of the transition period laid down in Article 110(3) IVDR can be made further available on the market without a legal time restriction.
•Article 2(2) of the proposal – adaptation of Article 112 IVDR
This provision adapts Article 112 IVDR to reflect the deletion of the 'sell-off' deadlines.
2023/0005 (COD)
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4), point (c), thereof,
After consulting the European Economic and Social Committee,
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure,
(1)Regulations (EU) 2017/745 19 and (EU) 2017/746 20 of the European Parliament and of the Council establish a new regulatory framework to ensure the smooth functioning of the internal market as regards medical devices and in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users. At the same time, Regulations (EU) 2017/745 and (EU) 2017/746 set high standards of quality and safety for medical devices and in vitro diagnostic medical devices in order to meet common safety concerns as regards such devices. Furthermore, both Regulations significantly reinforce key elements of the previous regulatory framework in Council Directives 90/385/EEC 21 and 93/42/EEC 22 and Directive 98/79/EC of the European Parliament and of the Council 23 , such as the supervision of notified bodies, conformity assessment procedures, clinical evidence requirements, vigilance and market surveillance, whilst introducing provisions ensuring transparency and traceability regarding medical devices and in vitro diagnostic medical devices.
(2)Due to the impact of the COVID-19 pandemic, the date of application of Regulation (EU) 2017/745 has been postponed by one year to 26 May 2021 by Regulation (EU) 2020/561 of the European Parliament and of the Council 24 , while the date of 26 May 2024 was maintained as end of the transition period by which certain devices that continue to comply with Directive 90/385/EEC or Directive 93/42/EEC may be placed on the market or put into service.
(3)Also due to the impact of the COVID-19 pandemic, the transition period provided for in Regulation (EU) 2017/746 has already been extended by Regulation (EU) 2022/112 of the European Parliament and of the Council 25 .
(4)Despite the steady increase in the number of notified bodies designated in accordance with Regulation (EU) 2017/745, the overall capacity of notified bodies is still not sufficient to ensure the conformity assessment of the large number of devices covered by certificates issued under Directive 90/385/EEC or Directive 93/42/EEC before 26 May 2024. It appears that a large number of manufacturers, especially small and medium-sized enterprises, are not sufficiently prepared to demonstrate compliance with the requirements of Regulation (EU) 2017/745, taking into account also the complexity of those new requirements. Therefore, it is very likely that many devices that may be placed on the market in accordance with the transitional provisions provided for in Regulation (EU) 2017/745 are not going to be certified in accordance with that Regulation before the end of the transition period, which leads to the risk of shortages of medical devices in the Union.
(5)In light of reports from healthcare professionals about the imminent risk of shortages of devices, it is necessary, as a matter of urgency, to extend the validity of certificates issued under Directives 90/385/EEC and 93/42/EEC and to extend the transition period during which devices that are in conformity with those Directives can be placed on the market. The extension should be sufficiently long to give notified bodies the time needed to carry out the conformity assessments required of them. The extension aims at ensuring a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of health services, without lowering current quality and safety requirements.
(6)The extension should be subject to certain conditions to ensure that only devices that are safe and for which the manufacturers have taken steps to transition towards compliance with Regulation (EU) 2017/745 will benefit from the additional time.
(7)To ensure progressive transition to Regulation (EU) 2017/745, the appropriate surveillance regarding devices benefiting from the transition period should eventually pass over from the body that has issued the certificate in accordance with Directive 90/385/EEC or Directive 93/42/EEC to a notified body designated under Regulation (EU) 2017/745. For reasons of legal certainty it should be provided that the notified body should not be responsible for conformity assessment and surveillance activities carried out by the outgoing body.
(8)As regards the period of time needed to allow manufacturers and notified bodies to carry out the conformity assessment in accordance with Regulation (EU) 2017/745 of medical devices that had been CE marked in accordance with Directive 90/385/EEC or Directive 93/42/EEC, a balance should be struck between the limited available capacity of notified bodies and ensuring a high level of patient safety and public health protection. Therefore, the length of the transition period should depend on the risk class of the medical devices concerned, so that the period is shorter for devices belonging to a higher risk class and longer for devices belonging to a lower risk class.
(9)Contrary to Directives 90/385/EEC and 93/42/EEC, Regulation (EU) 2017/745 requires the involvement of a notified body in the conformity assessment of class III custom-made implantable devices. Having regard to insufficient notified body capacity and the fact that manufacturers of custom-made devices are often small or medium-sized enterprises that did not have access to a notified body under Directives 90/385/EEC and 93/42/EEC, a transition period should be provided during which class III custom-made implantable devices may be placed on the market or put into service without a certificate issued by a notified body.
(10)Article 120(4) of Regulation (EU) 2017/745 and Article 110(4) of Regulation (EU) 2017/746 prohibit the further making available of devices which are placed on the market by the end of the applicable transition period and which are still in the supply chain one year after the end of that transition period. To prevent unnecessary disposal of safe medical devices and in vitro diagnostic medical devices that are still in the supply chain, thus adding to the imminent risk of shortages of devices, such further making available of devices should be unlimited in time.
(11)The adoption of this Regulation takes place due to exceptional circumstances arising from an imminent risk of shortages of medical devices and the associated risk of a public health crisis. In order to attain the intended effect of the amendments to Regulations (EU) 2017/745 and (EU) 2017/746 and to ensure availability of devices whose certificates have already expired or are due to expire before 26 May 2024, to provide legal certainty for economic operators and healthcare providers, and for reasons of consistency as regards the amendments to both Regulations, it is necessary for this Regulation to enter into force as soon as possible. For the same reasons it is also considered appropriate to provide for an exception to the eight-week period referred to in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the Treaty on European Union, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community,
HAVE ADOPTED THIS REGULATION:
Regulation (EU) 2017/745 is amended as follows:
(1)Article 120 is amended as follows:
(a)in paragraph 2, the second subparagraph is replaced by the following:
'Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC as from 25 May 2017 that were valid on 26 May 2021 and that have not been withdrawn afterwards shall remain valid after the end of the period indicated on the certificate until the dates set out in paragraph 3b for the relevant risk class of the devices. Certificates referred to in the first sentence that have expired before [OP please insert the date – date of entry into force of this Regulation] shall be considered to be valid until the dates set out in paragraph 3b only if one of the following conditions is fulfilled:
(a)before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device;
(b)a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) or has required the manufacturer, in accordance with Article 97(1), to carry out the applicable conformity assessment procedure';
(b)paragraph 3 is replaced by the following:
'3a. By way of derogation from Article 5 and provided the conditions set out in paragraph 3d of this Article are met, devices referred to in paragraphs 3b and 3c of this Article may be placed on the market or put into service until the dates set out in those paragraphs.
3b. Devices which have a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may be placed on the market or put into service until the following dates:
(a)31 December 2027, for class III devices and for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
(b)31 December 2028, for class IIb devices other than those covered by point (a), for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.
3c. Devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until 31 December 2028.
3d. Devices may be placed on the market or put into service until the dates referred to in paragraphs 3b and 3c of this Article only if the following conditions are met:
(a)those devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable;
(b)there are no significant changes in the design and intended purpose;
(c)the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
(d)no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9);
(e)no later than 26 May 2024, the manufacturer, or an authorised representative, has lodged a formal application in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraphs 3b and 3c of this Article or in respect of a device intended to substitute that device, and no later than 26 September 2024 the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII.
3e. By way of derogation from paragraph 3a, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to devices referred to in paragraphs 3b and 3c of this Article in place of the corresponding requirements in Directives 90/385/EEC and 93/42/EEC.
3f. Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in paragraph 3b of this Article shall continue to be responsible for the appropriate surveillance in respect of the applicable requirements relating to the devices it has certified, unless the manufacturer has agreed with a notified body designated in accordance with Article 42 that the latter shall carry out that surveillance.
No later than 26 September 2024, the notified body that has signed the written agreement referred to in paragraph 3d, point (e), shall be responsible for the surveillance in respect of the devices covered by the written agreement. Where the written agreement covers a device intended to substitute a device which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC, the surveillance shall be conducted in respect of the device that is being substituted.
The arrangements for the transfer of the surveillance from the notified body that issued the certificate to the notified body designated in accordance with Article 42 shall be defined in an agreement between the manufacturer, the notified body designated in accordance with Article 42 and, where practicable, the notified body that issued the certificate. The notified body designated in accordance with Article 42 shall not be responsible for conformity assessment activities carried out by the notified body that issued the certificate.
3g. By way of derogation from Article 5, class III custom-made implantable devices may be placed on the market or put into service until 26 May 2026 without a certificate issued by a notified body in accordance with the conformity assessment procedure referred to in Article 52(8), second subparagraph, provided that no later than 26 May 2024, the manufacturer, or the authorised representative of the manufacturer, has lodged a formal application in accordance with Section 4.3, first subparagraph, of Annex VII for the applicable conformity assessment, and no later than 26 September 2024 the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII.';
(c)paragraph 4 is replaced by the following:
'4. Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices placed on the market from 26 May 2021 pursuant to paragraphs 3a, 3b, 3c and 3g of this Article, may continue to be made available on the market or put into service.'
(1)in the first paragraph, the introductory wording is replaced by the following:
'Without prejudice to Article 120(3a) to (3f) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and to the obligations of manufacturers as regards the making available of documentation, under Directives 90/385/EEC and 93/42/EEC, those Directives are repealed with effect from 26 May 2021, with the exception of:';
(2)the second paragraph is replaced by the following:
'As regards the devices referred to in Article 120(3a) to (3f) and (4) of this Regulation, the Directives referred to in the first paragraph shall continue to apply to the extent necessary for the application of those paragraphs.';
(3)In Article 123(3), point (d), the twenty-fourth indent is replaced by the following:
'- Article 120(3e).'.
(1)in Article 110, paragraph 4 is replaced by the following:
'4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022, and devices lawfully placed on the market from 26 May 2022 pursuant to paragraph 3 of this Article may continue to be made available on the market or put into service.';
(2)in Article 112, the second paragraph is replaced by the following:
'As regards the devices referred to in Article 110(3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply to the extent necessary for the application of those paragraphs.'.
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the European Parliament For the Council
The President The President
(1) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(2) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU ( OJ L 117, 5.5.2017, p. 176 ).
(3) Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (OJ L 130, 24.4.2020, p. 18) had postponed the date of application of Regulation (EU) 2017/745 from 26 May 2020 to 26 May 2021 due to the COVID-19 outbreak and the associated public health crisis.
(4) Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices (OJ L 9, 28.1.2022, p. 3).
(5) In those three cases, the joint assessment team has already reviewed the applicants' corrective and preventive action plan. The length of the overall designation process varies considerably from case to case. Based on data from December 2021, the average length of the overall process was 842 days for a designation in accordance with the MDR.
(6) The MDCG has been established by Article 103 of Regulation (EU) 2017/745. It is composed of representatives appointed by Member States and chaired by a representative of the Commission. The MDCG is listed in the Commission's register of expert groups with the code X03565.
(7) Based on the results of a survey among notified bodies conducted end of November/beginning of December 2022; the respondents represent notified bodies that have issued around 80% of all certificates issued under Council Directives 90/385/EEC and 93/42/EEC that were valid in October 2022. This estimation does not take into account the number of first MDR certification of devices for which no certificates have been issued under Council Directives 90/385/EEC and 93/42/EEC and which require notified body involvement under the MDR.
(8) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17).
(9) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
(10) MDCG 2022-14 MDCG position paper Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs (August 2022).
(11) MDCG 2022-17 MDCG position paper on 'hybrid audits' (December 2022).
(12) MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD (September 2022); MDCG 2022-4 rev. 1 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD (December 2022).
(13) MDCG 2019-6 Rev.4 Questions and answers: Requirements relating to notified bodies (October 2022).
(14) Commission Delegated Regulation (EU) …/... of 1.12.2022 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies, C(2022) 8640, and Commission Delegated Regulation (EU) …/... of 1.12.2022 amending Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies, C(2022) 8649. The delegated acts are available in the interinstitutional register of delegated acts and are subject to a three months scrutiny procedure by the European Parliament and the Council.
(15) E.g. under the 2022 EU4Health Work Programme : a call for proposals aimed to foster capacity-building of existing and new notified bodies, to facilitate access of small and medium-sized enterprises (SMEs) and first-time applicants to notified bodies and to increase preparedness of manufacturers (see HS-g-22-19.03), various actions s upporting the implementation of Regulations on medical devices and in vitro diagnostic medical devices (see HS-p-22-19.04, 06, 07, 08, 09, 10 and 11) and d irect grants to Member States' authorities: reinforced market surveillance of medical devices and in vitro diagnostic medical devices (HS-g-22-19.01). Under the 2023 EU4Health Programme : support to the technical secretariat for Notified Bodies Coordination Group (see HS-p-23-63) and call for proposals for a program on orphan medical devices, in particular targeting paediatric patients (see HS-g-23-65).
(16) MDCG 2022-18 MDCG position paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate.
(17) Class Im means class I devices with a measuring function; class Is means class I devices that are placed on the market in sterile condition; class Ir means class I devices that are reusable surgical instruments.
(18) See Commission information note circulated as Council document 15520/22 of 6.12.2022.
(19) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(20) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
(21) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17).
(22) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
(23) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).
(24) Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (OJ L 130, 24.4.2020, p. 18).
(25) Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices (OJ L 19, 28.1.2022, p. 3).


text:
2021 Outdoors
That last sentence is pie in the sky nonsense. The only athlete who put bums on seats etc was UB a great athlete who had genuine charm and was mostly laughing at himself. The dreadful media mainstream and social media has no interest in athletics issues and performers and just wants to talk for a few days about this silly girl until the next bit of news takes over.
The social media freaks will do absolutely nothing for athletics. SO ludicrous that people would take up track or go to a meeting because of some fracas in the USA about somebody. The biggest reason why not, may be connected with the fact that a few days ago it was super shoes,tracks and doping but it's what was on TV this week end. The matters that drive discussion on American TV are beyond adult discussion ; the entire culture and value system is that of the madhouse. Dont let's worry the next sports issue is round the corner, awaited keenly by NBC and the social media twitter exponents.
fchd
Spoken like someone who is completely out of touch with how the next generation thinks
"bums on seats" isn't the metric used to determine whether something is successful anymore, "eyeballs on streams" is more important, and will continue to increase in relevance even more over the forthcoming years.
What's on American TV doesn't matter that much either, fewer and fewer are watching TV, news and discussions are being led by Social Media that you seem to dismiss so easily.
Laps commented
You are right about the way things are going but will eyeballs on streams appreciate empty stadiums and nil atmosphere?
It was interesting to observe the Anniversary Games crowd dwindle year by year after 2012 and the crowd's behaviour - attention span, interest in many of the events, movement in the crowd etc - steadily change. Athletics has a challenge. Some sports are adapting to the 'next generation'. Others will find it more difficult.
I think Athletics is one of those.
They are still talking about her 2 months after the trials and there is a WC next year where I can almost guarantee that any coverage in the US will feature her "redemption story" if she gets her head in the game. Again, as someone on the ground, as it were, I can only report how the story has been handled and what support/focus has been on her in the States from the general public. I'll just say this - there's far more people talking about athletics now (and her in particular) than there were 5 months ago.
And this might be hard for some people to imagine, but my comment about encouraging people to take up track or attend a meet wasn't limited to those in the English countryside. If you can't see why Richardson might appeal to a section of the younger generation in the States that might not seriously have considered athletics before now, I don't know what else to say.
None of us can say with any certainty what will happen, but I'm willing to say that if we think that just having quiet, mild mannered well performing athletes is honestly the way forward in keeping the sport alive and centre stage, I think we're probably all guilty of smoking what Richardson was. There's a reason that they do fancy light shows, and staged intros, at events now. People want to be entertained. We don't necessarily have to like that, but it's the reality we face.
Yeah, the cricket hundred was instructive. Personally I hate the format - give me a test match going into the final session on the 5th day any day of the week.
But I'm a dinosaur (or at least feeling like one) and there's no doubt the short snappy format with peripheral stuff going on clearly appeals. It brought in big crowds and many trying cricket for the first time; for some a good night out will morph into a real love of the game.
While I don't like gimmicks, there's no doubt that athletics must up its appeal.
Ref the Anniversary Games that was hideously over bloated. IIRC it initially spanned 3 days including one devoted to Para - that was crest of a wave stuff and never going to last. In the current era the action has to be high quality and come thick and fast.
Athletics is also best served in stadia where fans are close to the action and the Olympic Stadium isn't that. Fine for global champs that attract big crowds but soulless otherwise.
i wonder if McColgan has races to run this year still; it would be a disappointing end after so much promise in the early summer.
Sovietvest
You're hard to please Philipo. McColgan fulfilled the promise of her early season runs with a British 5,000m record and a highly creditable performance in the Olympic 10,000m. What more could we expect? She's had a great year.
Well completely misunderstood, presumably deliberate. The promise I referred to was her 14.28 of early summer. Her performances await her races if any ,post Tokyo. You guys love shouting out for performances, I look for consistency. Her 14.28 was done on July 1st. Summer was 10 days old. Thus my post said "early summer".
Last edited by philipo; 26-08-21, 04:28.
Sam Talbot will be taking part in this weekend's multi-event championships in Manchester according to the England Athletics preview, as is Andrew Murphy, a 7500 man from a few years back
Ladyloz
Originally posted by treadwater1 View Post
I saw that.
At Manchester this weekend it's the Under 17 and Under 15 Age Group Combined Event Champs.
But Talbot et al are taking part in something called the European Athletics Combined Events Challenge. Not sure of the calibre of entries from overseas. But with the demise of the European Cup Combined Events this could be a much needed addition to the calendar for me. There needs to be international competitions outside of the World Athletics Combined Events Challenges (the traditional late season meeting in that series in Talence has been cancelled this year.) to provide opportunities for athletes including Ranking Points.
jjimbojames commented
Sam is taking part - solid start so far. Would love him to give the 400H a serious try, but he's less keen! Tough to learn an 11th event and especially when it's one where you need to commit to see the big chunks of time drop off….
carterhatch commented
Yes, JimboJames, just good to see Sam competing in a multi events again...
Indeed…hopefully a good Day 2 to come
Fabulous running from Francine Niyonsaba, I'm pleased for her, she has always handled the situation she finds herself in with dignity, but I feel she is well on her way to proving the IAAF correct.
The rigid diamond league structure has led to some slightly flat meetings post Tokyo. After those incredible performances at the Olympics the most in demand athletes are not being showcased. There hasn't been a male 400 hurdles race since Tokyo and only one women's triple jump in the last three meetings.
There is a men's hurdles race in Brussels, but there we won't see Rojas jump until the final meeting in Zurich. The conditions were perfect today, it would have been great to see her have another crack at the WR
WORLD RECORD at the Antrim Coast Half Marathon!
Yalemzerf Yehualaw ran 63:43 demolishing Ruth Chepngetich's 64:02 from Istanbul in April.
60.34 pb for Marc Scott in the men's event.
None of the Brits did owt great at the Rovereto WACT Silver meeting.
Catalin Tecuceanu (ROU) was a very surprise winner of the 800 in 1:45.19 (a 0.55s PB). He races a lot in Italy so I think he must be based there.
There was a pair of good 3000m races. In the Women's race there was a ton of PBs (not marked correctly on the official results) - Svetlana Aplachkina (ANA) 8:39.95 PB led home 4 women at 8:41 or better including Elena Burkard 8:40.46 PB and Dani Jones 8:41.01 PB. Sarah Healy bettered her PB from 12 days ago by 5 seconds with 8:52.63 for 6th place.
In the Men's ... Elzan Bibic has really found some form, outkicking Iguider to win in 7:39.45 PB.
Michael Cherry won the 400 in 44.55 and eased up with 10m to go for some reason, jogging over the line.
Christin Hussong won the Diamond League Jav with a 66.06 best from Muze & Ogrodnikova.
Full Results: http://www.fidal.it/risultati/2021/C...TSBYEVENT1.htm
trickstat commented
Apparently, Tecuceanu is close to being qualified for Italy.
trevorp
Originally posted by LuckySpikes View Post
Did anyone watch it? I see Rowden DNF.

redpajama_set_name: RedPajamaCommonCrawl


text:
Gerhard Johann David von Scharnhorst, född 12 november 1755 i Bordenau vid Neustadt am Rübenberge i Hannover, död 28 juni 1813 i Prag, var en preussisk militär. Han är känd för sina banbrytande militärreformer och sina insatser under Napoleonkrigen.

Biografi
Scharnhorst tjänade först i den hannoverska armén, där han, efter att ha utmärkt sig i kriget mot Frankrike 1793, befordrades till major. 1801 ingick han som överstelöjtnant vid artilleriet i preussisk tjänst samt utnämndes till direktör för den preussiska infanteri- och kavalleriofficersskolan. Hans undervisningsreformer gjorde dock att han fick så många fiender att han själv anhöll om förflyttning till annan befattning.

År 1803, året efter han adlats, utnämndes han till generalkvartermästarlöjtnant i generalstaben och till överste 1804. Som hertigens av Braunschweig generalstabschef deltog han sedan i kriget mot Napoleon.

Efter freden i Tilsit (1807) blev han generalmajor och chef för krigsdepartementet samt var ordförande i kommissionen för reorganisering av militären 1807–1810. I den rollen gjorde han stora insatser för det preussiska försvarsväsendet, särskilt genom att åstadkomma en arméorganisation, som genom den korta tjänstetiden gjorde det möjligt att utbilda ett jämförelsevis stort manskap under den tid, då Preussen traktatsenligt inte fick hålla mer än en mindre beväpnad styrka, det så kallade Krümpersystemet.

Krigsministeriet delades nu upp i två avdelningar, det allmänna krigsdepartementet med Scharnhorst som chef och militärekonomidepartementet för handläggning av förvaltningsärenden. Alla regementen utom sju upplöstes, och olämpliga eller obrukbara officerare bestraffades eller avskedades. Härens ombildning hämmades i väsentlig mån av pengabristen och genom Krümpersystemet, enligt vilken fredsstyrkans siffra (42 000 man) liksom regementenas antal fastställdes. Likväl indelades armén i sex blandade brigader. Stor vikt lades vid skjutning och övningar i spridd ordning, adelns företrädesrätt till officersplatser avskaffades, den tidigare gemensamma ekonomin kompanivis utbyttes mot fasta löner, militärutbildningen förbättrades och "krigsskolan" inrättades. De överordnades anseende skulle nu baseras på kunskaper samt intellektuell och sedlig överlägsenhet.

En vida mer genomgripande förändring än officerskåren undergick manskapet. I stället för värvning trädde nu den allmänna värnplikten; den omfattade alla krigsdugliga, rika och fattiga, lärda och obildade, och den tog inte bara soldatens kroppsliga utan också hans andliga egenskaper i anspråk. För att öka truppernas antal tillgrep Scharnhorst ett slags permitteringssystem, varigenom från man varje kompani entledigade 3–5 man, som ständigt ersattes med rekryter vars utbildning endast pågick en månad och för vilka man i händelse av krig höll vapen och kläder i beredskap. De hårda kropps- och skamstraffen avskaffades.

I befrielsekriget 1813, där värdet av hans verksamhet framgick, tjänstgjorde han, utnämnd till generallöjtnant, som Blüchers stabschef. Redan i det första större fältslaget, vid Grossgörschen samma år, blev han dödligt sårad.

Scharnhorst utmärkte sig även som militärskriftställare och som stiftare av militärsällskapet i Berlin (1802). Hans Briefe började utges 1914.

Skepp med namnet Scharnhorst
 SMS Scharnhorst
 Scharnhorst (1936)

Referenser

Externa länkar

Preussiska generaler
Preussens krigsministrar
Militärteoretiker
Walhalla
Födda 1755
Avlidna 1813
Män
Deltagare i slaget vid Jena-Auerstedt

redpajama_set_name: RedPajamaWikipedia


In the following you get some impressions from the time sensitive projects. For further information please contact info@doerriesgalabau.de.
e.g. Parkstraße in the VW- Autostadt Wolfsburg, Style Outlets Zweibrücken or the forecourt Hotel The Ritz Carlton Wolfsburg.
At request of the customer the time sensitive projects where completed. Working 7 days a week, working at night and in special case 24/7 have been requested and rewarded by the customer.


The Norwalk Hour is a daily newspaper published in Norwalk, Connecticut, by Hearst Media Services, Connecticut. It primarily covers and serves the city of Norwalk.
The newspaper was founded in 1871. It was published under the title The Evening Hour from 1895 into the 1900s, at which point it was renamed The Norwalk Hour. Some time after 1971, it became simply The Hour. The newspaper covers local news, business, sports, and entertainment, and as of April 2003, had a circulation of 16,070. In 2000, The Hour shifted from afternoon to morning deliveries.
In 2003, competition between The Hour and its larger rival, The Advocate, came to a head. On May 15, the Stamford-based competitor began circulating a special Norwalk edition with significantly increased local coverage and a price that substantially undercut The Hour. The rivalry escalated to barbs traded on editorial pages.
Hearst, which took control of the Advocate in 2008, acquired The Hour for an undisclosed price in a deal announced in April 2016. The seller was the Nellie M. Thomas Trust, owner of the Hour Publishing Co. According to reports, its print circulation at the time was about 12,000 daily copies. On June 25, 2017, the newspaper was reflagged The Norwalk Hour. The move coincided with its relocation to 301 Merritt 7 in Norwalk, along with the offices of Hearst Connecticut Media.
^ "About The evening hour. (Norwalk, CT) 1895-190? « Chronicling America « Library of Congress". Chroniclingamerica.loc.gov. Retrieved 26 November 2014.
^ a b The Hour's Directory, The Hour, retrieved June 11, 2009.
^ "1971 scans of the newspaper still titled "The Norwalk Hour"". News.google.com. Retrieved 26 November 2014.
^ About this newspaper: The Hour, Chronicling America, Library of Congress, retrieved June 11, 2009.
^ Non-responders: Newspapers not replying to the ASNE newsroom survey, ranked by circulation (DOC), Power Reporting, retrieved June 11, 2009.
^ Norwalk Paper Shifts To Morning Delivery, The New York Times, September 18, 2000.
^ a b "Newspapers Are the News in Norwalk", The New York Times, July 27, 2003.
^ "Old-Fashioned Newspaper Circulation War on Westport's Doorstep", Westport Now, June 20, 2003.
^ "Hearst Acquires Print and Digital Assets of The Hour (Norwalk) and Wilton Villager in Connecticut". hearst.com. Retrieved 12 April 2018.
^ "The Hour Newspaper in Norwalk Sold to Hearst". patch.com. 13 April 2016. Retrieved 12 April 2018.
^ "At The Norwalk Hour, an old flag and a new headquarters". thehour.com. Retrieved 12 April 2018.
This page was last edited on 25 August 2018, at 05:34 (UTC).


text:
Understanding Sheung Yiu's mind-bending photography
by Wilfred Chan
Sheung Yiu's deceptively whimsical pictures are entryways into a theoretical approach to images.
"My photography is very slow. I might have to think for a month before I know what I want to do."
"My project is about looking at the spectrum of scientific imagery, figuring out its logic and aesthetics."
"Photography's essence, is it about reality and falseness? Is it a lie?"
"Photography is an enigma. The attractive thing about it is that you can show people something, but it can't completely convey your thoughts."
"It's not just about considering the technical aspects or the appearance, but what's the essence of the medium?"
"I'm just not someone who's very interested in making beautiful photos."
"Sometimes I think my work doesn't matter. It doesn't matter if people look at my work, because I get the most fun out of making them."
"I find it interesting how photography used to be so important to science and now it's so superfluous, it's just there to fill the spaces."
"You can only take so many beautiful pictures before, at some point, they all become really boring."
"Every time I do a project I will do a lot of research. I'll try to understand the origins of the subject, why they came to be this way."
"I like to use photographs because they appear so real, but everything inside is constructed, everything to some degree is staged."
"Photography's essence—is it about reality and falseness? Is it a lie?"
Sheung Yiu is one of Hong Kong's most interesting conceptual photographers, though of course, he would never say that. "Sometimes I think my work doesn't matter," he says, and admits even his parents don't fully get what he's trying to do. That may not be their fault. The self-taught 26-year-old — who also goes by Kenneth — is as much an artist as a philosopher: his deceptively whimsical pictures are records of his thorough, often demanding investigations into the nature of images.
Sheung Yiu makes work that is playful yet systematic, pleasurable yet challenging. In his award-winning series "(PHOTO)graphy", he contorts images into themselves, manipulating color, texture, and flatness, to expose the peculiar way the medium mimics the world. His latest project "Look Like Science" builds on this approach, revealing the often half-truthful way photography describes things we accept as scientific fact. Can thinking about photography help us understand the way we think about science, and hence, the way we think about reality?
A photograph by Sheung Yiu often contains a stroke of deadpan humor (his first project was literally a dick joke). But each punch line — and sometimes it is subtle — invariably includes an insight into visual thinking. Working backwards from the punch line, you can deconstruct the picture to understand its underlying concerns. Sheung Yiu is like a teacher who shows you the answer, then asks you to figure out the question.
Still / Loud has the honour of calling Sheung Yiu a contributor and a friend. We interviewed him shortly before he left to pursue an MFA at Aalto University in Finland—what started as a quick chat in McDonald's turned into a discussion about images, beauty, science, and truth.
Sheung Yiu. Courtesy of the artist.
Still / Loud: Tell us about how you started making photographs.
Sheung Yiu: I went to a city called Figueres—that's Salvador Dali's birthplace—and I went to some museums and really liked surrealism. So my first photographs were surrealist still lifes. I used things that were in my dorm or things I got from the supermarket. Like two avocados and then some penne pasta—avocado comes from the Aztec word for testicle, and penne is like [the Italian word for penis] pene—and I somehow made them into a composition.
But I didn't explain to people the meaning; I just thought the process was interesting. Like, you could hide a message inside the photograph, but when you show someone, they might not know it's there.
Photography is an enigma. The attractive thing about it is that it can't completely convey your thoughts.
You worked in commercial photography, but you didn't like it.
When I was a commercial photography assistant, I learned how things like, what's a portrait, what's lighting. I still feel grateful to the people I met those days. But I never thought I would be a commercial photographer. I feel like commercial photography is about being impressive. And in that environment you have to be really fast. I can't bear that pressure, getting chur-ed by people.
My photography is very slow. I might have to think for a month before I know what I want to do.
Sheung Yiu. Michael Chiu, Still / Loud
In commercial photography, you're showing people the surface level. If you were learning calligraphy, and you ask, why do you draw that dot that way, or why do you use this kind of ink, these things are not interesting questions. It's missing the point.
Even if you look at the history of painting, in the Renaissance, artists really emphasised realism. They studied perspectives and compositions while contemporary artists have a different entry point. They play with surface, framing, color, they experiment with gesture and motion. It gets to a point where paintings became very abstract.
When an art slowly evolves, it will get to a very meta state. It's not just about considering the technical aspects or the appearance, but what's the essence of the medium? Photography's essence—is it about reality and falseness? Is it a lie? Or are photographs like a photogram, just light and composition, completely abstract and has nothing to do with what you were photographing?
When did you start seeing things this way?
It's hard to say. When I started making work, I wanted to do something that didn't have to do with appearance or the look of something. As I made more work I started to understand what kind of photographer I am. I'm just not someone who's very interested in making beautiful photos—
But your photos are beautiful.
—beauty isn't the most important thing. Of course I have my own aesthetic; I want my images to meet a certain standard. But I wouldn't sacrifice the rest of my objectives in pursuit of that standard.
I think every photographer, at some time in their career, will arrive at this. You can only take so many beautiful pictures before, at some point, they all become really boring. They will all be sunsets, beautiful landscapes, models. What else—you know—what else? Are you satisfied with just taking beautiful pictures your whole life?
How do you judge contemporary works?
If I don't see your artist's statement, I would want to still understand what your idea is. If you don't need a long essay to intellectualise what you're trying to do, and I can see your photograph, and with just a little bit of background I can understand what you're trying to do, and there's a vibe, then I feel it's a good work.
It's not my job to shove my work in front of people. I don't need to write an artist's statement and repeat it to everyone I meet, because you're not interested in it anyway, and you have better things to do.
Sometimes I think my work doesn't matter. It doesn't matter if people look at my work, because I get the most fun out of making them.
So how do you decide what to shoot?
You have to put a lot of material into your brain and then let the material slowly connect to each other. And then you can do something. What that is, I can't articulate exactly. I just know I can't just pull something out of thin air.
Of course, my photos aren't very technically advanced. If you know how to make photographs, and you wanted to replicate what I've done, you could.
Sheung Yiu. Wilfred Chan, Still / Loud
You're working on a science photography project—tell us about it.
I was a science student. I was looking at some old science books at home—from a photographer's perspective, I thought this was really interesting. I started looking into the history, how photography and science are so intricately linked, how photography has been an essential tool for scientists since its inception. It was evidence, because the camera can see what the human eye can't see, it directly registers what's in front of it.
Scientists tried hard to show the camera as "the pencil of nature." They wanted to use the dark box to accurately register reality, as a form of evidence. Take radiation: Henri Becquerel accidentally left some photo paper out and discovered radioactivity after seeing the exposure. So that has historical weight.
But when I see what's presented to me in science textbooks, which is ridiculous stock photos and illustrations, I don't see that much thought put into it; it carries so little strength. So why is it like this? I was dissatisfied and I wanted to investigate this discrepancy. I find it interesting how photography used to be so important to science, but now in science education it's so superfluous, it's just there to fill the spaces.
So my project is about looking at the spectrum of scientific imagery, figuring out its logic and aesthetics. To study them like an entirely new system of visual language.
And what have you discovered?
I didn't really pay much attention to science photos before I was a photographer, and now it's almost like I understand the world deeper in a sense. I'm more conscious about my relationship with images.
You can only take so many beautiful pictures before, at some point, they all become really boring.
Every time I do a project I do a lot of research. I'll try to understand the origins of the subject, why they came to be this way. I have a book called Revelations, and it discusses the use of photography as evidence.
There's an example of an industrialist trying to figure out how many shoes his workers were making on an assembly line. So he asked a photographer to do a long exposure. He made two photographs to reveal the difference between skilled and unskilled workers. Unskilled workers made a lot of movements, so you could see the light trails. Skilled workers' motions were much tighter, showing that they worked much more efficiently.
While scientists have used photography as hard evidence, people have also used photography to try and prove pseudo-scientific things. I think there's something in the middle—like using a photograph to survey workers—and that I find interesting.
Something between a truth and a lie.
For those photographers back in the day, their work was not a lie. They were really trying to register truth onto a photographic plane—tried to reduce scientific truth and physics into a photo. But now we are in a very postmodern way of thinking about photography—how everything is staged, how everything can be Photoshopped.
I like to use photographs because they appear so real, but everything inside is constructed, everything to some degree is staged. That's the beauty of photography—how real it looks even though you're telling a lie.
An exhibition of Sheung Yiu's latest project, "Look Like Science", is on view beginning January 15, 2018 at Node Gallery in Helsinki through January 26. The opening reception is on January 19.
Interview by Wilfred Chan and Michael Chiu. Holmes Chan contributed editing. This interview is condensed and translated from Cantonese.
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Pulwama, Jammu and Kashmir
Islamic University of Science and Technology (ISLAMIC-UNIVERSITY)
The Islamic University of Science and Technology (IUST), Awantipora, Kashmir has been established in year 2005 at Jammu & Kashmir. While the university started functioning in November, 2005 the teaching programme was started in July 2006. The University is located in Awantipora, a small picturesque town situated on the main national highway (NH1A) in Kashmir approximately 30 km south of the capital city of Srinagar and adjacent to the shrine of Syed Hassan Mantaqi.
Get Islamic University of Science and Technology Results & Iust university result at islamicuniversity.edu.in
Islamic University of Science and Technology is a public university located at Awantipora. Get Islamic University of Science and Technology Results & Iust university result at islamicuniversity.edu.in Community Initiatives Besides, imparting formal education to the younger generation, the University realizes its role for community development especially given its rural setting. We take every opportunity possible to reach out to the local community and seek means and mechanisms to connect to it. In this direction, IUST with the help of many individuals/ organizations who are experts in their respective fields have made various efforts to reach out to the local community and raise awareness, make their grievances reach the authorities, apprise them of the latest technologies and trends to make their work easy and more attractive.Islamic University of Science and Technology results are available on Indiaresults.com as well.
For More Details Please Visit Our Website:- www.islamicuniversity.edu.in
Prof. Mushtaq A. Siddiqi
vc@islamicuniversity.edu.in
Prof. Naseer Iqbal
registrar@islamicuniversity.edu.in
Dr. M.A. Bhat
examinations@islamicuniversity.edu.in
1-University Avenue
Awantipora
City : Pulwama
State : Jammu and Kashmi


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Wombs For Rent In Laos As Surrogacy Finds New Home
Nicola Burridge | Life
With the recent banning of surrogacy in many countries in southeast Asia, fertility clinics in Laos are cashing in, offering wombs for rent at a more affordable price than in wealthier nations.
Fertility clinics are springing up all over Laos, in an attempt to attract foreign clients who may be struggling to secure a surrogate in another country, either due to the cost of surrogacy in their own country or the legalities.
Surrogacy was declared illegal in Thailand in 2015, with Cambodia banning it in 2016, as a result of various scandals and lawsuits, including the infamous baby Gammy case, concerning the Farnell's, an Australian couple who refused a baby due to it being born with Down's syndrome.
Surrogacy In Laos
The Farnell's had hired a Thai woman, Pattaramon Janbua, as a surrogate mother. Ms. Janbua ended up carrying twins for the couple. However the boy twin, later named Gammy, was diagnozed with Down's syndrome seven months into the pregnancy. The Farnell's requested that Pattaramon Janbua abort the boy due to his illness. However, Ms. Janbua refused to co-operate due to her Bhuddist beliefs.
Baby Gammy with his surrogate mother Pattaramon Chanbua. (Photo: NPR)
The Farnell case received international exposure and prompted the Thai government to take action on the unregulated surrogacy market. Foreigners are now banned from entering into surrogacy contracts in Thailand.
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Despite surrogacy being banned in Thailand, the babies from surrogates are often born in Thailand, due to Laos not having the equipment or facilities to deal with the many multiple births that come from surrogacy. Surrogates will often travel to Thailand before giving birth, to benefit from the more advanced medical facilities and neonatal care units that are available in the country.
A surrogates giving birth in Thailand does not break Thai law, as the surrogates are not Thai, nor were the surrogacy procedures carried out in Thailand. However, the official stance and what actually occurs remains a blurred line.
In a recent investigation Reuters contacted three hospitals in Bangkok, they all reported that they don't accept births by surrogates. Yet, when speaking to Australian, Anthony Fisk, who had used a Cambodian surrogate (before the ban) he said that the child was born in Thailand without any problems. He noted that their "child was born to two foreign nationals in Bangkok".
There are no official figures for the number of IVF or fertility clinics in Laos, but they have seen a vast increase in the numbers recently, with many of them using words such as "perfect" and "miracle" in their business names.
Vientiane, Laos, has seen a boom in surrogacy agencies since neighbouring countries have imposed stricter laws on the industry. (Photo: Youtube)
Laos is one of the poorest countries in Asia and is also a hub for crime, particularly for the smuggling of illegal items, including, wildlife, drugs and semen. As recently as April this year, a man was arrested in Thailand for attempting to smuggle human semen into Laos. The six vials of semen were hidden in a nitrogen tank and seized in the Thai border town of Nong Kai. The smuggler confirmed that the vials were destined for a fertility clinic in the Laos capital of Vientiane.
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With Laos being such a poor country, the surrogacy cost is much less than in other countries, with only Ukraine and Kenya having lower costs. On average it will cost a little more than $50,000 for the whole package, which includes everything from the surrogacy screening to the birth.
Warsaw Radio Mast Led the World until 2009
Despite the surrogates only receiving a small part of the total cost of surrogacy, compared to wages in the country, it is a significant amount. One surrogate from Laos, who spoke to reporters, confirmed that she was paid for the surrogacy, where she carried twins, and received $8000, which works out to be nearly three times higher than the average annual wage in Vientiane. She was also provided with accommodation in Bangkok, Thailand.
The director of the Australian non-profit organization, Families Through Surrogacy, Sam Everingham, says that more and more people are looking to Laos for wombs for rent, and that their sessions and conferences have attracted around 600 couples and single people, just in Australia, in the last four years.
However, other organizations have warned people to avoid looking to Laos for surrogacy options, as there are warnings that the country may follow suit with the rest of southeast Asia, and put an end to the business.
Yet, the surrogacy clinics in Laos are still promoting their wombs for rent businesses, with many of them promoting their surrogacy services – and particularly the lower surrogacy cost – not just to western clients but increasingly to China.
Surrogacy was made illegal in China in 2001 and now, with the one child law being relaxed, more couples may be looking for a second child but be unable to conceive themselves, due to age or other circumstances.
According to figures published by the China Population Association, over 40 million Chinese couples have trouble conceiving. That's a significant 1 in 8 Chinese couples. It's also no secret that the one child policy has helped to create a demographic time bomb. For the fifth year in succession the labor force shrank and to compound the problem the proportion of the population over 60 is steadily increasing. How does a shrinking work force support a top heavy, ageing population, who also happen to be living longer?
It is estimated that more than 10,000 Chinese babies are born every year to surrogates. More cost effective solutions in Laos may appeal to Chinese couples but Chinese media are reporting that the Chinese government may relax their hardliner stance on non-commercial surrogacy.
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The communist regime in Laos has tolerated the boom in surrogacy agencies across the country. How long they continue that policy remains to be seen.
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The TempIR Pulse Oximeter is the perfect solution for individuals who want to accurately and non-invasively monitor the oxygen saturation levels of their blood. A simple to use device that simply clips to the user's finger to provide SpO2 (oxygen saturation levels) and pulse rate (bpm). This review of the TempIR Pulse Oximeterhas been written by Tristan Haskins aka CardioCritic.
Pulse Oximeters are a bit like thermometers – every household should own one. They are particularly important for families with a history of asthma, COPD, heart and lung related illness / disease. A Pulse Oximeter is a cheap, accurate and easy way to measure the levels of saturated oxygen in the blood. A two minute daily check provides peace of mind when your SpO2 levels are normal. It can also give an early warning signal when your blood's oxygen saturation levels drop below your "normal" levels.
A pulse oximeter is a device that measures the percentage of haemoglobin in the blood that is carrying Oxygen – something called Oxygen Saturation. The pulse oximeter emits two different frequencies of light, red light and infrared light.
These waves of light pass through the skin of the fingertips. On the opposite side of the light sources there is a detector.
This sensitive detector analyses the levels of light that has been absorbed to provide the SpO2 reading. If you'd like more information on the scientific principles of how a pulse oximeter works please refer to HowEquipmentWorks.com for a detailed explanation (external link).
Normal pulse oximeter readings usually range from 95 to 100 percent. Values under 90 percent are considered low.
The resting Pulse Rate between healthy adults varies even more than the SpO2 readings. I'm quite an active male (born 1968) with a resting heart rate around 45bpm.
The TempIR Pulse Oximeter accurately measures both SpO2 and pulse rate (beats per minute). The values of both are LIVE and will change throughout the monitoring period.
The photograph below illustrates the key features of the TempIR pulse oximeter as listed on the packaging.
This device is NOT intended to provide CONTINUOUS monitoring (as you'd find in a hospital), but it does have alarms for both SpO2 and pulse rate. These alarms are really just for convenience. While monitoring yourself or family member it is not necessary to continually stare at the screen if an alarm has been set, for example an SpO2 levels of less than 94%. More details on alarms and other system settings is covered further down this article.
For convenience and comfort the TempIR Pulse Oximeter has 4 different display views. Simply press the button briefly to flip through all 4 display options. Each press flips the display by 90° to facilitate easy reading.
Pressing and holding the single button enters SETUP mode. In setup mode there are TWO menus. Alarm Setup and Sounds Setup. To alter / enter any setting just toggle to the setting then press and HOLD the button to change the setting.
In the SOUNDS setup menu there are 4 options.
Beep – adds a BEEP to represent each Heart Beat.
Demo – puts the device in to demonstration mode. The SpO2 and BPM values are set to 98 and 60 respectively. Use this cautiously as it looks for all intents and purposes like a HEALTHY / NORMAL reading ….
Restore – resets all the menu settings to factory default.
Customer's love this product. Just read a sample of the online reviews below and you will understand why this is one of the BEST SELLING Pulse Oximeters on the market. Easy to use, easy to read, reliable and accurate, what more could you want from such a device.
CardioCritic has awarded the TempIR Pulse Oximeter a stunning 5/5 Star Review. There is nothing to criticise with this product from it's low price to it's superb quality. It arrived direct from the supplier with 2 x AAA batteries in the box. 2 minutes from receiving the unit I was recording my SpO2 levels with ease, accuracy and consistency. The TempIR Pulse Oximeter is HIGHLY RECOMMENDED by CardioCritic.com.