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 the manufacturers of medical devices. We enlist here the two most important effects of the new clinical evaluation requirements, related to:
1. Re-classification:
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 process. It is expected that from when the new MDR will enter into force, the ‘’clinical risks’’ will be addressed in the conformity assessment route, as well as in the post-market surveillance and clinical modernization. From 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.
2. 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 will become applicable, much stronger clinical evidence will be needed to demonstrate safety and efficacy of the 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.
No doubts that the new Regulation will require extensive efforts for all the parties involved, that is why we are constantly working to find the better ways to put into practice and apply the new requirements in the near future.
To learn more about the major changes introduced by the new Regulation on Medical Devices, or if you wish to learn more about the CE marking or the EU compliance process, contact us today!
Emiliano D’Urso