MDCG 2021-8: Clinical Investigation Application / Notification Documents 🆕

While the EUropean Database on MEDical devices is still being rolled out/finalized, a number of documents for clinical investigation application and notification have been created to support MDR clinical investigation procedures.

 The documents include:

-          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

🔗 Original Site: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-8_en.pdf