The Medical Devices Introductory Course 2020

Key requirements and approvals CLINICAL INVESTIGATIONS

The Organisation for Professionals in Regulatory Affairs

Clinical Investigations: Requirements (MDR)

• Article 62 - General requirements (includes a checklist of 13 requirements - all must be met to proceed) • See also Articles 63 to 80, Article 82, and any acts adopted pursuant to Article 81 • Requirements regarding clinical investigation set out in Annex XV • Article 120 (11): Clinical investigations which have started in accordance with MDD prior to 26 May 2021 may continue to be conducted

• As of 26 May 2021 reporting of serious adverse events and device deficiencies must be carried out in accordance with MDR

The Organisation for Professionals in Regulatory Affairs