The EU Medical Device Regulation (MDR) 2017/745 represents a significant shift in how medical devices are evaluated and approved in Europe. Unlike the previous directives, the MDR places greater emphasis on clinical evidence and the demonstration of safety and performance.
One of the key pathways for generating clinical evidence is through equivalence to an existing device. However, the MDR has introduced stricter requirements for demonstrating equivalence compared to the previous Medical Device Directive (MDD).
MEDDEV 2.7/1 revision 4, while not legally binding under the MDR, continues to provide valuable guidance on clinical evaluation. The principles outlined in Appendix A1 regarding equivalence remain highly relevant and are widely referenced by notified bodies.
This page will help you understand the requirements for demonstrating equivalence under the EU MDR and avoid common pitfalls that can lead to non-conformities or delays in your certification process.
To demonstrate equivalence, you must show that both devices are equivalent in three key areas:
The predicate device must be lawfully marketed in the EU and must have a valid CE mark. You cannot use devices that are no longer on the market or devices that have been withdrawn due to safety concerns.
You must provide a detailed side-by-side comparison of your device with the predicate device across all three characteristics. This comparison must be scientifically justified and documented thoroughly.
Clinical data from the predicate device must be integrated into your clinical evaluation report. You must justify why this data is relevant to your device and explain any differences in the clinical context.
Notified bodies expect a clear and transparent approach to equivalence. Any ambiguity or insufficient justification can result in non-conformities. Document everything meticulously.
Conduct a comprehensive literature review to support your equivalence claim. This includes peer-reviewed publications, regulatory guidance, and any other relevant scientific evidence.
Your equivalence assessment must be integrated with your risk management file. Any differences between devices must be addressed in the risk analysis and mitigation strategies.
Notified bodies frequently identify issues with equivalence claims. Here are the most common mistakes:
Our regulatory and clinical experts have extensive experience in demonstrating equivalence under the EU MDR. We can help you navigate the requirements, avoid common pitfalls, and accelerate your path to market.
