The Medical Devices Introductory Course 2020

Some Key Horizontal Standards

• ISO 13485 - Quality Systems for Medical Devices • ISO 14971 – Risk Management • ISO 10993 series – Biocompatibility Testing • EN ISO 14155 series – Device GCP • IEC 60601 series – Electromedical Safety • IEC 62304 – Software Life Cycle Process • IEC 62366 – Usability Engineering • ISO 11737 series – Sterilisation • ISO 22442 series – Animal Derived Materials • ISO 15223- Symbols • ISO 20417 > EN 1041 – Labelling

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs

Clinical Investigation - Is it required for medical devices?

• Clinical Evaluation is required for all devices to show compliance with the MDD Essential Requirements (ERs) / MDR (GSPRs)

• Clinical Evaluation Report may comprise clinical documentation (literature review / history of use / critical evaluation) and/or clinical investigation

• Clinical investigations are required if the ERs / GSPRs cannot be satisfied by any other means

• Unless duly justified, clinical investigations are required for all implantable and Class III (high risk) devices – equivalency route can only be used through contract

• ‘GCP’ for devices is outlined in EN ISO 14155 series standards

• Guidance: MEDDEV 2.7/1 rev.4 – Clinical Evaluation / MDCG 2020–1; 2020-5; 2020-6

• Clinical investigations require ethics committee approval and notification to Competent Authorities in markets where study centres situated

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs