Sponsors of a clinical investigation of a medical device are required to submit an application/notification to the Member State(s) in which the clinical investigation is to be conducted in line with the provisions set out in the European Union (EU) Medical Device Regulation (MDR).
The implementation of the MDR brings with it the introduction of the European database on medical devices (EUDAMED) through which the application/notification must be submitted. However, at the time of application of the MDR, EUDAMED is not fully operational. In its absence, the Medical Devices Coordination Group (MDCG) have released a list of document templates to support clinical investigation procedures.
The documents provided are:
- Clinical investigation – application/notification form under the MDR
- Addendums to the application notification form for:
- Additional investigational 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
Sponsors are encouraged to use these documents however it is imperative that they check with the individual Member State in which the clinical investigation will be conducted to comply with any specific national requirements. These templates will be withdrawn once the EUDAMED module for clinical investigations becomes fully operational.
The full guidance including the list of templates can be found here.