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1、Summary Evaluation Reporton the Assessment of a Medical Device by the Notified Bodyfor Conformity with Council Directive 93/42/EEC and Commission Directive 2003/32/EC.Template Document - enter text directly to expandable box.Reporter Reference1. Report sent by :2. Notified Body No :3. Country:4. Sen
2、t 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 Data11. Produc
3、t 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
4、 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 alternativ
5、e 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 Statement18. Conclusion of this assessment:Based on the evaluation of data and the assessment pro
6、cess 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 Record19. This report was sent ontothe Coordinating Competent Authority of to seek an opinion from the Competent Authorities of the other Member States.