Module 15 2022

20/05/2022

Chapter III

Other Obligations Of The Sponsor • Making available all documentation to the NCAs listed in Chapter II • Ensure any SAE’s (or other events in Article 80(2)) are reported to the sponsor in a timely manner • Ensure all documents listed in Annex XV are held for the following time:  10 years after the clinical investigation has completed, or  10 years after the last device is placed on the market, 15 years for implantable. • Ensure an appropriate monitor is appointed (independent from the site). • Ensure the follow up of investigation subjects • Ensure (and be able to prove) the clinical investigation is conducted to Good Clinical Practice • Prepare a Clinical Investigation Report covering all essential items.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

17

MDCG 2021-08

Clinical Investigation application/notification documents MDCG 2021-08 sets out guidance to be followed in the absence of EUDAMED. The application/notification documents associated with MDCG 2021-08 have been created to support Clinical Investigation procedures with respect to the MDR, are as follows: • Clinical investigation – application/notification form under the MDR • Addendum to the clinical investigation application/notification form for:

 Additional investigational device(s)  Additional comparator device(s)  Additional investigation site(s)

• Clinical investigation supporting documents - Appendix of documents to attach • Checklist of general safety and performance requirements, Standards, common specifications and scientific advice

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

18

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