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Custom-made medical devices (“CMMDs”) are defined by the Medical Devices Directive (“the MDD”) as devices specifically made in accordance with and under the responsibility of a duly qualified medical practitioner’s written prescription, giving specific design characteristics and intended for the sole use of a particular patient. The prescription may also be issued by any other person authorized by virtue of their professional qualifications to do so. However, a custom-made implantable medical device can be prescribed only by a medical specialist in accordance with the Directive on active implantable medical devices.
An example of a CMMD that can be provided is dental appliances prescribed by a dentist and manufactured by dental laboratories.
Please note that according to the MDD mass-produced devices that need to be adapted to meet the specific requirements of a medical practitioner or any other professional user are not considered to be custom-made devices (e.g. contact lenses).
Placing CMMDs on the EU market
First and foremost, CMMDs must comply with all the essential requirements applicable to all types of MDs, such as:
general requirements as to safety and health of patients;
requirements as to MD design and construction (including chemical, physical and biological properties; infection and microbial contamination; construction and environmental properties; protection against radiation; requirements for medical devices connected to or equipped with an energy source).
Needless to say, labelling and usage instruction requirements must also be observed as in this case the label will state the particular “custom-made device” together with the name/ trade name and address of the manufacturer (or authorized representative) and details strictly necessary for the user to identify the device and the contents of the packaging.
A manufacturer of CMMDs or their authorized representative, must draw up a statement prior to placing each CMMD on the market. The statement must contain the following information:
data allowing identification of the CMMD;
a statement that the device is intended for exclusive use by a particular patient and the name of the patient;
the name of the medical practitioner or other authorized person who issued the prescription and, where applicable, the name of the clinic concerned;
the particular features of the device as specified in the relevant medical prescription;
a statement that the device in question conforms to essential requirements and, where applicable, indicating which essential requirements have not been fully met, together with the grounds for non-conformity.
The statement concerning the CMMD should be available to the patient for whom the device has been produced. The manufacturer must keep documentation pertaining to the design, manufacture and performance of CMMDs, including expected performance, available for the competent authorities. In addition, the MDD empowers Member States to require manufacturers to submit a list of CMMDs which have been put into service in their territory (as is the case with Bulgaria, Hungary, Latvia and Lithuania).
It should also be noted that CMMDs are exempt from:
the requirement to bear CE marking when placed on the market;
the rule regarding intervention by notified bodies.
As outlined above, CMMDs and their regulation involve some specifics which must be taken into account when they are launched on the market. Otherwise, non-compliance with MDD requirements may result in withdrawal of CMMDs from the market or in a prohibition or restriction as to placing them on the market or putting them into service.
Our Life Sciences & Pharma experts will be glad to provide you with legal assistance in the successful realisation of your healthcare and medicine projects.
Source: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices; 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
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