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)

EU’s Governmental Bodies

Medical Device CE Marking