What is a medical device in the EU?

The New Medical Devices and IVD legislation was adopted in May 2017. It brought significant changes with impact on a wide range of companies dealing with medical devices. If they want to continue to market medical devices in the EU they will have to adapt their working processes and meet new requirements. A lot of work is to be done in a short (transitional) period of time. It's a challenge also for companies planning to enter the EU market. 

Medical devices companies should make their regulatory strategy their priority and gain the knowledge and understanding of the new rules and requirements and make an individual plan for achieving the compliance. 

Gaining knowledge and understanding of over 600 pages of the new legislation related to medical devices and IVD require significant time, efforts and resources, but it's a precondition for proper planning and performing your activities. 

Our pool of seminars is designed to save time and resources and enable you quick and simple understanding of EU rules and requirements on medical devices.  

The starting point is understanding of what a medical device or IVD is in the EU. The scope of regulations on medical devices and IVD is changed in the new legislation adopted in May 2017 (MDR 745/2017 and IVDR 746/2017). Changing the definition of a medical device and an IVD device has consequences. Some products that were not covered by previous directives are now included into the new definition. On the other hand, some products that were excluded from Directive 93/42/EEC or otherwise out of the scope of the directives are now explicitly included into the scope of the Regulations. In addition, some products are explicitly excluded from the scope of the new Regulation on medical devices.

This seminar will help you in a simple and comprehensive way to understand the scope of products regulated by Medical Devices and IVD regulations, to interpret correctly the definitions including products' medical purposes and mode of action as well as to understand inclusion-exclusion rules. It also explains categorisation of combination products between medical devices and IVD and between medical devices and medicinal products.