Division 2.2 Renewal of certificates

In the context of its decision regarding the extension for a further period of maximum five years of F1a design-examination certificate or a type-examination certificate in accordance with F2regulation 18(3) or regulation 31(3) of the Medical Devices Regulations 2002, respectively, the F3approved body shall review for the purpose of this Regulation at least the following aspects:

1. (a)

   updated justification for the use of animal tissue or derivative, including a comparison with lower risk tissues or synthetic alternatives;

2. (b)

   updated risk analysis;

3. (c)

   updated clinical evaluation;

4. (d)

   updated test data and/or rationales, for example in relation to the current harmonised standards;

5. (e)

   identification of any changes made since the issue of the original certificate (or last renewal) that could impact the TSE risk;

6. (f)

   evidence that the design dossier remains state of the art in relation to TSE risks.