Supporting documents should be provided in a SEARCHABLE format Applications and supporting documentation must be in English APPLICANTS’ SUBMISSION CHECKLIST Signed application form, at a minimum the Declaration page(s) Application Form in .doc format QMS certificates for Packaging Supplier(s) – If applicable Essential Requirements Checklist Risk Management documentation Sterilisation Validation(s) data – if applicable Packaging and device stability data Biocompatibility data – if necessary Specific References to DuPont Transition Material Data DECLARATION(S) BY APPLICANT In making this application we declare: The information in this form is correct We have not lodged an application with any other notified body to undertake conformance assessment procedures for the same product(s) / device-related quality system mentioned. We undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions and notifications, taking account of the nature and risks in relation to this product. We agree to provide all vigilance reports to the Competent Authorities and NSAI We agree to pay all applicable fees and understand that non-payment of fees will result in withdrawal of approval. We undertake to fulfil the obligations imposed by the quality system approved We undertake to keep the approved quality system adequate and efficacious. We agree to inform NSAI that approved the quality system of any plan for substantial changes to the quality system or the product-range covered. We shall submit to NSAI any changes to the approved design, wherever the changes impact conformity with the essential requirements of the Directive or with the conditions prescribed for the use of the device. We authorise NSAI to carry out all the necessary inspections at the legal
Supporting documents should be provided in a SEARCHABLE format Applications and supporting documentation must be in English APPLICANTS’ SUBMISSION CHECKLIST Signed application form, at a minimum the Declaration page(s) Application Form in .doc format QMS certificates for Packaging Supplier(s) – If applicable Essential Requirements Checklist Risk Management documentation Sterilisation Validation(s) data – if applicable Packaging and device stability data Biocompatibility data – if necessary Specific References to DuPont Transition Material Data DECLARATION(S) BY APPLICANT In making this application we declare: The information in this form is correct We have not lodged an application with any other notified body to undertake conformance assessment procedures for the same product(s) / device-related quality system mentioned. We undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions and notifications, taking account of the nature and risks in relation to this product. We agree to provide all vigilance reports to the Competent Authorities and NSAI We agree to pay all applicable fees and understand that non-payment of fees will result in withdrawal of approval. We undertake to fulfil the obligations imposed by the quality system approved We undertake to keep the approved quality system adequate and efficacious. We agree to inform NSAI that approved the quality system of any plan for substantial changes to the quality system or the product-range covered. We shall submit to NSAI any changes to the approved design, wherever the changes impact conformity with the essential requirements of the Directive or with the conditions prescribed for the use of the device. We authorise NSAI to carry out all the necessary inspections at the legal