What is new in the Medical Device Regulation with regard to the clinical evaluation requirements?
The Medical Device Regulation introduces a lot of new specific requirements on clinical, specifically on the clinical evidence level which is needed for fulfilment of the Medical Device Regulation, and processes which are needed to fulfil that specific requirement.
So what I’m referring to here is the fact that the Medical Device Regulation clearly explains to medical device industry that they have to implement the clinical evaluation in their quality management system by building up processes and templates to fulfil that requirement. This means that notified bodies during quality management audit, which can be normal audit or focused audit such as clinical audit, will look on their processes to understand whether they have a clinical evaluation process, a post-market clinical follow-up process and so on, to avoid that they get technical documentation at the end which are not in compliance with the Medical Device Regulation, and to ensure that medical device industry is taking the feedback from notified bodies during the clinical evaluation assessment process and implementing that in their quality management system avoiding a repetition of systematic failure which are happening as of today but should be avoided for the future by controlled processes in quality management system.
