Guidelines

MEDDEV 2.7/1 Revision 4. Guidelines for Clinical Evaluation

GHTF/SG5/N6:2012. Clinical Evidence for IVD medical devices– Key Definitions and Concepts

GHTF/SG5/N7:2012. Clinical Evidence for IVD medical devices – Scientific Validity and Performance Evaluatio

GHTF/SG5/N8:2012. Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices

GHTF/SG5/N4:2010. Post-Market Clinical Follow-Up Studies

MedTech Europe. Clinical Evidence Requirements for CE certification under IVDR

Accredited Notified Bodies under MDR

Accredited Notified Bodies under IVDR

ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 14971:2007 Medical devices — Application of risk management to medical devices

ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice

MDCG endorsed documents and other guidance relevant to MDR and IVDR