Conformity Assessment Options for Products Failing under the MDR Evaluation of Devices Suspected of Presenting an Unacceptable Risk or other Non-Compliance under the MDR and the IVDR (Art. 94/89) The Periodic Safety Update Report (PSUR) under the MDR and the IVDR (Art. 86/81) The Person Responsible for Regulatory Compliance (PRRC) under the MDR and the IVDR (Art. 15/15) The Field Safety Notices under the MDR and the IVDR (Art. 89(8)/84(8)) The Post-Market Surveillance (PMS) Plan under the MDR and the IVDR (Art. 84/79) The Certificate of Free Sale under the MDR and the IVDR (Art. 60/55) The General Obligations of Manufacturers – Financial Coverage – under the MDR and the IVDR (Art. 10) EC Factsheets for MDR and IVDR Medical Device Regulations in Europe Posts navigation 1 2