The clinical evaluation of a medical device is intended to critically evaluate the clinical benefits of a given device against the potential risks it poses to patients. As such, clinical evaluations are an essential element of the risk management process applicable to medical devices under regulatory approval schemes in most major markets around the world. At the same time, more rigorous requirements for clinical evaluations under the European Union’s (EU’s) new medical device regulation (MDR) are expected to extend the application of clinical evaluation requirements to a broader range of medical device manufacturers, while also increasing the regulatory compliance complexity for all.
The latest revision of the European Commission guidance document on clinical evaluations of medical devices, MEDDEV 2.7/1 revision 4, provides device manufacturers with an effective roadmap for achieving compliance with clinical evaluation requirements. Published in June 2016, the revised guidance document is specifically applicable to medical devices and active implantable medical devices, and is already being adopted by EU Notified Bodies in their assessment of clinical evaluations.