Clinical Evaluation for medical devices (new requirements under MDR)

With the aim to ensure a higher level of health and safety through transparency and traceability of medical devices, the new MDR requirements on clinical evaluation are expected to be the greatest challenge for manufacturers of medical devices.

The following are the two most important effects of the new clinical evaluation requirements, related to:


While in the past, it was common to have risk management and clinical evaluations as entirely separate processes; the new Regulation now considers them as a connected and mutually dependent. It is expected that as soon as the new MDR enters into force, the ‘’clinical risks’’ will be addressed in the conformity assessment route, as well as in the post-market surveillance and clinical modernization. Based on this, manufacturers of medical devices may be required to review the classification of their devices – that will be based on clinical evaluation data on top of their potential risk.

Comparative Evaluations:

The new MDR does not only call for stricter clinical evaluation requirements but also increases the level of examination expected for all classes of devices. When the MDR becomes applicable, much stronger clinical evidence will be needed to demonstrate safety and efficacy of medical devices, as clinical justifications based on device equivalence will no longer be easily accepted – in other words the new Regulation is introducing stricter requirements for comparative evaluation.

There is no doubt that the new Regulation will require extensive efforts from all the parties involved, which is why we are constantly working to find better ways to put its new requirements into practice and apply them in the near future.

To learn more about the major changes introduced by the new Medical Devices Regulation, or if you wish to learn more about the CE marking or the EU compliance process, contact us today!

Emiliano D’Urso

in News