clinicalevaluationreport

  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 ...

  The manufacturer of a medical device must produce a   clinical evaluation  report, CER, to document the   clinical evaluation   and its result. The MEDDEV Guideline 2.7/1 rev.4 defines clinical evaluation as a procedure that involves the collection, estimation, analysis and evaluation of available clinical data to support compliance of the medical device with the Essential Requirements. The  clinical evaluation report  or CER must contain sufficient information to be read and understood by an independent agent. You must provide enough detail to understand the search criteria adopted by the evaluators, the data available, the assumptions made, and any conclusions reached. WHAT SHOULD A CER CONTAIN It is important that the report describes the different stages of the clinical evaluation: Stage 0, scope of clinical evaluation: – explains the scope and context of the evaluation, the technology on which the medical device is based, the...