What do the terms mean and what is required for medical devices?

Course description:

In order to be able to CE mark a medical device, support from clinical evidence is needed. For the vast majority of products, this means that clinical data must be available. A clinical evaluation assesses whether existing data are sufficient to establish that the product is safe and functions adequately when used as intended. During the entire life of the product, a renewed clinical evaluation must then be performed at regular intervals to ensure that there is still sufficient clinical evidence to keep the product on the market. During this webinar we give you an overview of the concepts.