The sponsor of a clinical investigation is required to submit an application/notification1 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 of Regulation (EU) 2017/745 (MDR).2 The application/notification is required to be submitted by means of the electronic system referred to in Article 73 of the MDR.
In the absence of the European database on medical devices (EUDAMED), a series of clinical investigation application/notification documents have been created to support clinical investigation procedures with respect to MDR.
• Clinical investigation – application/notification form under the MDR
• Addendum to the clinical investigation application/notification form for:
o Additional investigational device(s) (section 3)
o Additional comparator device(s) (section 4)
o 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
Insofar as possible, the clinical investigation application/notification form includes same data fields to the EUDAMED system in development.