Medical Device Directives - Pharmaceutical Regulation - Which one applies to my new idea?
Medical products and pharmaceuticals must be approved before they may be sold in the European Union. Basically, the type of effect and intended use of such products or pharmaceuticals determine whether they are subject to the Medical Device Directive or the Pharmaceutical Regulation. However, such categorization isn't always that simple, since there are combination products or medical products that also contain an active pharmaceutical substance.
To help out in such situations, the course provides an overview of the European Directives on various categories of medical products and on the Pharmaceutical Regulation. The course offers aids for determining which Directive is relevant, explains the conformity assessment procedure and the pharmaceutical marketing authorization application, and introduces the participating institutions for medical devices and pharmaceuticals.
The course explains the differences between the conformity assessment procedure and the pharmaceutical marketing authorization application as well as the procedures necessary for a combination of a medical device and a medicinal product, or for medical devices incorporating a medicinal substance having an ancillary action. Questions regarding the special requirements of pharmaceutical guidelines for combination devices will be answered: What has to be taken into consideration in the development phase, during routine production, and during the marketing phase? What documentation is needed? The course also provides an overview of the quality management system ISO 13485 (medical devices) versus EU-GMP (pharmaceuticals).
The course addresses the importance of taking the approval process into account early in the development stage, and discusses typical timelines. Several case studies illustrate the theoretical information and participants can apply their new knowledge in specific examples. |