DOES YOUR CLINICAL EVALUATION MEET THE REQUIREMENTS OF THE MDR 2017/745 REGULATION?
We are currently witnessing a change in the regulations for medical devices. The current Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/ECC) will be replaced by the European Medical Device Regulation 2017/745 (MDR) next May 2021. As we have already commented in other entries, for a medical device to be marketed in the European Union, it must comply with the CE marking according to the requirements of this new regulation. This will introduce major changes to the way medical device manufacturers gain access to the European market, including the way Clinical Evaluation Report of the medical device is carried out. WHAT ELEMENTS MUST A CLINICAL EVALUATION HAVE TO COMPLY WITH THE REGULATIONS? Medical device regulations do not specify exactly how a clinical evaluation should be structured. But it does make clear the elements that must be taken into account. Therefore, having the experience of having carried ...