The sponsor of a performance study is required to submit an application/notification1 to the Member State(s) in which a performance study is to be conducted, accompanied by the documentation referred to in Chapter I of Annex XIV of Regulation (EU) 2017/746 on in
vitro diagnostic medical devices (the IVDR). The application/notification must be submitted by means of the electronic system referred to in Article 69 of the IVDR.
In the absence of the European database on medical devices (EUDAMED), a series of performance study application/notification documents have been created to support performance study procedures with respect to the IVDR.
These documents include:
- Performance study – application/notification form under the IVDR
- Addendum to the performance study application/notification form for:
o Additional performance device(s) (section 3)
o Additional comparator device(s) (section 4)
o Additional site(s) (section 5) - Performance study supporting documents – Appendix of documents to attach
- Checklist of general safety and performance requirements, standards, common specifications and scientific opinions…
