APPLICANTS’ SUBMISSION CHECKLIST Completed application form (Word format, .doc or .docx) Application (min. Signed Declaration page(s)) scanned QMS certificates for all sites in Table 1 Draft Declaration of Conformity Labelling & IFU – May be Drafts Essential Requirements Checklist including Harmonised Standards Performance/Complaint Analysis for the current certification period ( from date of last if less than one year please revert to previous cycle) Risk Management summary documentation concluding the device is safe for its intended use Sterilisation Validation(s) – if sterile/intended to be sterilised (copy of the most recent protocol and reports) Packaging and device stability data – if necessary , to support the claimed shelf life Biocompatibility data – if necessary, summary of test data Electrical Safety Testing data – if necessary, summary of test data including copies of associated certificates Software/firmware lifecycle documents – if necessary Bench Testing data – if necessary, summary of bench test results Clinical Evaluation Report(s) per MEDDEV 2.7.1 Not required for Class IS & IM Clinical Evaluation procedure Clinical investigation(s) report(s) and supporting documents per MEDDEV 2.7.1 Not required for Class IS & IM If following literature review/ equivalent device route, please complete and attach NSAI Equivalence form GRF-25-28 Not required for Class IS & IM Copy of existing Notified Body Certificate(s) Transition Plan (Ref Team NB Template) Please include a complete Team NB Template Contact details for existing Notified Body, including formal permission to contact existing Notified Body. Copy of last re-certification review carried out by current Notified Body (NSAI will not contact the existing Notified Body prior to agreement with the Manufacturer) For Tissue of Animal Origin falling under TSE Regulation 722/2012 EU Please complete Appendix A For Human Blood Derivatives Please complete Appendix B validation
Section 7: PERFORMANCE/COMPLAINT ANALYSIS 1. Is there a product history for this device Yes No If “No” please identify equivalent device(s) and relevant performance data a. What is the time period of the data being provided – b. What are the: Total no. units placed on the market worldwide) Total no. of complaints worldwide Total Number of EU Vigilance Reports 2. Please provide: Trended analysis (graphical form) of the data over the stated period of time. Summary table of the individual complaints, with quantity and % total sales 3. Please summarize all global Vigilance issues that fulfil the European Reporting requirements in the following/similar format:
2. Please confirm the number of sterilisation cycles that the device and packaging were subjected to prior to stability testing - 3. Please describe the preconditioning applied (eg. Ageing, transport etc): 4. Is compliance with EN ISO 11607 latest version claimed Yes No If “no” please justify: 5. Please list and supply all relevant reports which substantiate the claimed Packaging shelf life – Section 10: BIOCOMPATIBILITY Please confirm the categorisation of the devices with respect to Body Contact and Duration of Contact in Table 6 below & the testing conducted in Table 7 1. Is compliance with EN ISO 10993-1 latest version claimed Yes No If “no” please justify: 2.