 Active implantable medical device  Other medical device

Product description and composition

Information on intended use

EDQM certificate available  YES  NO(If the EDQM certificate is available, it must be submitted with this summary evaluation report.)

Information regardingthe nature of the starting tissue(s):animal species(s):geographical source(s):

A description of the key elements adopted to minimise the risk of infection:

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:

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:

The approach to the auditing of source establishments and suppliers for the animal material used by the device manufacturer:

Based on the evaluation of data and the assessment process it is our preliminary decision that the application meets the requirements of conformity with

 Part 3 of the Medical Devices Regulations 2002  Part 2 of the Medical Devices Regulations 2002

and Regulation (EU) No 722/2012.

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.