The Medical Devices Introductory Course 2020

Clinical Investigations: General Requirements (MDR)

• Conducted in accordance with ethical principles • Procedures and research methodologies should be appropriate • Design and endpoints should address features in relation to intended purpose, safety/performance and expected clinical outcomes • Performed in accordance with signed Clinical Investigation Plan and in line with the CEP • Investigators shall have access to the technical and clinical data regarding the device • Personnel involved should be adequately trained • Clinical Investigation Report, signed by investigator contains a critical evaluation of all data (both favourable and unfavourable)

Annex IV Chapter I

The Organisation for Professionals in Regulatory Affairs

Clinical Investigation Notification (MDD)

• Notification applications using specified format are submitted to the relevant Competent Authority (CA) in the Member State(s) in which the investigation is conducted (usually requires payment of a fee) • Can commence investigation 60 days after notification unless advised to the contrary by CA, or earlier if given clearance by CA • Specific filing format, requirements and review timeframes vary by CA • Rejection may be based on considerations of public health or public policy

The Organisation for Professionals in Regulatory Affairs