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Clinical Evaluation: What Changes Result from the MDR?
By focusing clinical safety the requirements for clinical evaluation are increased profoundly by the MDR, at the same time uncertainty regarding the specific demands is increasing. Items such as clinical evaluation program, equivalence approach versus clinical study, usability, claims, misuse, market monitoring and so on are to be discussed.
The MDR emphasizes clinical safety, to be demonstrated by a clinical evaluation, which on the other side shall not only be started together with the development of the medical device, but be also directly updated with data not only from post-market experience and scientific literature during the whole product lifecycle.
At the same time, there are no detailed requirements regarding that topic in the wording of the law, and only few additional details compared to the current MDD.
The question arises, which aspects at all, and how theses aspects shall be taken into consideration: Scientificity of the approach, setup of the clinical evaluation program, demonstration of clinical usability, proof of claims, required evaluation of foreseeable use or misuse, perspective of the clinical evaluation, required (pro-)active post-market clinical follow-up, expertise of the author of a clinical evaluation are taking the centre stage, in addition to the “long runner” named equivalence approach.
On the other hand, there is the scheduled obligation to perform clinical trials for specific products or under specific circumstances. While it seems clear that a more consistent approach for all medical devices to demonstrate the clinical essential requirements is necessary, the possibilities and limitations of formal clinical studies should be kept in mind. This is especially relevant with regard to the demonstration of functionality of a device in everyday clinical practice.
In addition, the influence of the clinical user and the patient on an adequate assessment of the risk-to-benefit ratio is mandatory, besides pure technical functionality of a medical device.
--- Date: 12.04.2018 Time: 10:45 AM - 11:10 AM Location: Hall Brüssel I, NCC Mitte