The European Commission’s Medical Device Coordination Group (MDCG) has published two new publications supporting the implementation of the EU IVDR.
And this is such a great news since we finally got long lasting templates regarding performance study.
Both publication emphasize that sponsor of a performance study needs to submit an application/notification to the Member State(s) in which a performance study is to be conducted. With the application/notification the documentation referred to in Chapter I of Annex XIV of Regulation (EU) 2017/746 on in vitro diagnostic medical devices need to be accompanied. If one or more performance studies are needed, they must be planned, approved, conducted and reported in accordance with the procedures in Articles 57-77 and Annex XIII and potentially Annex XIV.
Until the European database on medical devices (EUDAMED) is fully online, a series of performance study forms have been created to support performance study procedures with respect to the IVDR.
Therefore, in the MDCG 2022-19 and MDCG 2022-20 you can find:
- Application/notification form under the IVDR
- Addendum to the performance study application/notification form for:
- Additional performance device(s)
- Additional comparator device(s)
- Additional site(s)
- Performance study supporting documents – Appendix of documents to attach
- Checklist of general safety and performance requirements, standards, common specifications, and scientific opinions
- Substantial modification of performance study under In Vitro Medical Device Regulation
We will post updates to the guidance as they become available.