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 new guidance describes the requirements to be fulfilled by the sponsors of clinical investigations and introduces a series of clinical investigation application/notification documents to be used in support of clinical investigation procedures with respect to the MDR in the absence of EUDAMED. Moreover, the MDCG has clarified that the Union-wide unique single identification number for a clinical investigation CIV-ID shall be used for all relevant communication.
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.
It is important to keep in mind, that the forms are only temporary and are expected to be withdrawn once the EUDAMED module for clinical investigations is fully operational.
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
The above documents are available in the CLINICAL EVALUATION category of our MDlaw Library of Documents!
MDCG 2021-08: Clinical investigation application/notification documents. Retrieved on 25/05/2021 from : mdcg_2021-8_en.pdf (europa.eu)