The Medical Devices Introductory Course 2020

Differences between MDR and IVDR

MDR

IVDR

Single Use devices, System and procedure packs and Implant Cards, Products with no medical purpose

No equivalent

Summary Safety and Clinical Performance (Imp+III)

Summary Safety and Performance (C+D)

Clinical Evaluation and Clinical Evidence (CER) Post Market Surveillance Plan and Report (Class 1), Periodic Safety Update Report (Iia+)

Performance evaluation, Performance studies and Clinical evidence (PER) Post Market Surveillance Plan and Report (A+B), Periodic Safety Update Report (C+D)

Post Market Clinical Follow-up

Post Market Performance Follow-up

The Organisation for Professionals in Regulatory Affairs

Design – Clinical Performance and Evidence

Actively updated

Performance Evaluation Report

throughout life cycle of the device

Scientific Validity

Analytical Performance

Clinical Performance

The Organisation for Professionals in Regulatory Affairs May/may not be required Based on risk classification. For standardised or established assays with justification

Always Required

Always Required

Similar to IVDD with some specific requirements

Data retrieved from literature is acceptable

Proprietary and confidential — do not distribute