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)