Connected Medical Devices To Necessitate Clinical Evaluation Requires MDR
The now ubiquitous Internet of Things did not spare the Medical Devices segment, and what is commonly referred to as Internet of Medical Things or Connected Medical Devices is of course well within the MDR reach.
One of the major changes introduced by the MDR, compared to the previous regulation, is that sufficient clinical evidence of the safety and performance of the device are not merely a recommendation any longer but an actual necessity. While no specific methodology is suggested by the MDR, the French Haute Autorité de Santé which is, among others, responsible for the evaluation and appraisal recommendation of Health Products and Technologies, recommends to use Randomized Controlled Trials (RCT), if possible double-blind.
In the particular case of Connected Medical Devices, this poses a few challenges. Not only the timeline of an RCT is much longer than the life cycle of the device, it is also rarely compatible with the pace of evolving regulations on that matter. This is why observational or pilot studies can be used to gather preliminary data.
Key indicators selection also requires particular attention, due to the specificities of the devices, and global indicators need to be taken into account.
The subject is admittedly very much subject to interpretation and the EC decision of April 17th to put off the implementation of the MDR by one year is a real opportunity to rethink the evaluation strategies, in full collaboration with the relevant national bodies.