Medical device CE marking

MDCG published guidance regarding documents to be provided when an IVDR performance study is to be conducted


The sponsor of a performance study is required to submit an application/notification 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:
    • Additional performance device(s) (section 3)
    • Additional comparator device(s) (section 4)
    • 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

The document can be downloaded from our library: MDCG 2022-19

Source: European Commission