According to the German Medical Devices Act (MPG) §19 para. 1 and Annex X para. 1 of the EU Directive 93/42 /EWG, the suitability for the intended use must be demonstrated for each medical device, as well as its medical risks need to be assessed. This is done with a clinical evaluation, based on medical literature, own investigations or on the basis of clinical trials.
According to EU Directives 93/42 / EEC, medical device manufacturers are committed to establish appropriate monitoring programs in their quality management system for the lifetime of the medical device starting with the beginning of the market entry (post-market surveillance, PMS).
The PMS activities are supposed to ensure the routine review of the clinical safety and performance of the medical device, so that also rare adverse events and risks that occur only in the context of a broad and long-term use are recorded and evaluated.
With regard to the increasing regulatory requirements – in particular in the detection of clinical performance and safety of your medical device, both before and after the market launch, the Dr. Notghi Contract Research GmbH is your competent partner in the successful implementation.
We are in regular dialogue with a notified body. You too can benefit from our extensive know-how, we gladly support you in the planning and execution of tasks in the field of clinical contract research (clinical evaluation, clinical examination, post-market surveillance). Enhance your education and visit one of our events on current topics.
You have a need for flexible and efficient solutions? Then you are exactly right here! It is our pleasure to advise you personally. We look forward to your call or message.