The Medical Device Coordination Group (MDCG) has endorsed a document on the topic of clinical investigation application/notification since EUDAMED module for clinical investigations is not yet functional.
The sponsor of a clinical investigation is required to submit an application / notification to the Member State(s) in which a clinical investigation is to be conducted, accompanied by the documentation referred to in Chapter II of Annex XV, Regulation (EU) 2017/745.
The application / notification is required to be submitted by means of the electronic system referred to in Article 73 of Regulation (EU) 2017/745.
Competent Authorities and sponsors are encouraged to make use of published documents, while checking for possible national requirements of the Member State in which the clinical investigation is to be performed.
The templates included in the Annex of the MDCG guidance are:
- Clinical investigation – application/notification form under the MDR (including same data fields as EUDAMED system in development.)
- Addendum to the clinical investigation application/notification form for:
- Additional investigation device (s) (section 3)
- Additional comparator device(s) (section 4)
- Additional investigation site(s) (section 5)
- Clinical investigation supporting documents – Appendix of documents to attach
- Checklist of general safety and performance requirements, Standards, common specifications and scientific advice
It is important to keep in mind, that the forms are only temporary and are expected to be withdrawn once the EUDAMED module for clinical investigations is fully operational.
Source: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-8_en.pdf