ANNEX IISupplementary provisions
ANNEX II Summary Evaluation Report in accordance with Article 5(4) of Regulation (EU) No 722/2012 Details relating to the submitting notified body 1. Name of notified body 2. Notified body number 3. Country 4. Sent by 5. Contact person 6. Telephone 7. Fax 8. E-mail 9. Client reference (name of manufacturer and, if applicable, of authorised representative) 10. Confirmation that, in accordance with Article 11 of Directive 90/385/EEC and Article 16 of Directive 93/42/EEC, respectively, and Article 4 of Regulation (EU) No 722/2012, the submitting notified body has been designated by its competent authority for the conformity assessment of active implantable medical devices manufactured utilising tissues of animal origin subject to Regulation (EU) No 722/2012, medical devices manufactured utilising tissues of animal origin subject to Regulation (EU) No 722/2012 Data relating to the (active implantable) medical device 11. (a) Active implantable medical device Other medical device 11. (b) Product description and composition 12. Information on intended use 13. Starting material 13. (a) EDQM certificate available YES NO (If the EDQM certificate is available, it must be submitted with this summary evaluation report.) 13. (b) Information regarding — the nature of the starting tissue(s): — animal species(s): — geographical source(s): 14. A description of the key elements adopted to minimise the risk of infection: 15. An estimate of the TSE risk arising from the use of the product, taking into account the likelihood of contamination of the product, the nature and duration of patient exposure: 16. A justification for the use of animal tissues or derivatives in the medical device, including a rationale for the acceptability of the overall TSE risk estimate, the evaluation of alternative materials and the expected clinical benefit: 17. The approach to the auditing of source establishments and suppliers for the animal material used by the device manufacturer: Notified Body Statement 18. Conclusion of this assessment: Based on the evaluation of data and the assessment process it is our preliminary decision that the application meets the requirements of conformity with Council Directive 90/385/EEC Council Directive 93/42/EEC and Regulation (EU) No 722/2012. Date of submission 19. This report was sent on … to the Coordinating Competent Authority of … to inform the Competent Authorities of the other Member States and the Commission and to seek their comments, if any.