欧盟指导原则 Summary Evaluation Report on the Assessment of a Medical Device by the Notified Body.docVIP

Summary Evaluation Report on the Assessment of a Medical Device by the Notified Body for Conformity with Council Directive 93/42/EEC and Commission Directive 2003/32/EC. Template Document - enter text directly to expandable box. Reporter Reference 1. Report sent by : 2. Notified Body No : 3. Country : 4. Sent by: 5. Contact person: 6. Telephone: 7. Fax: 8. E-mail: 9. Client Reference : 10. Our Designating Competent Authority has confirmed the scope of our activities meets the provisions of Article 16 of Council Directive 93/42/EEC and Article 4 of Commission Directive 2003/32/EC. Medical Device Data 11. Product description and composition: 12. Information on intended use: 13. Nature of the starting tissue(s), animal species(s) and 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/or third party 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 this application meets the requirements of conformity with Council Directive 93/42/EEC and Commission Directive 2003/32/EC. Distribution Record 19. This report was sent on ............................. to the Coordinating Competent Authority of ............................................ to seek an opinion from the Competent Authorities of the other Mem