As a manufacturer, but also as an importer or distributor of medical devices, you are subject to a complex legal system made up of European and domestic regulations. The same applies to your sales.
The European Medical Device Regulation (MDR) entered into force on 26 May 2021 and gives manufacturers a “transition time”, depending on the risk class of their device, up to 31 December 2027 or 31 December 2028 respectively. The regulation poses various new questions both for many legal manufacturers and other economic actors, such as the classification and labelling of products or in the context of conformity evaluation processes or hospital assessments.
I am happy to help you with any questions you may have concerning medical device law.
- Support for market launches (conformity assessments, certification processes and questions of refunds)
- Help in upholding compliance requirements under constantly changing legal rules and regulatory constraints
- Compliance with and consideration of sector-specific codes of conduct
- Implementing product call-backs and liability cases
- Clarifying questions of delimitation involving pharmaceuticals, biocide products, cosmetics and combination products
- Advice on the design of advertising vehicles and on the product presentation, labelling and instructions for use (IFU)
- Legal representation both in court and extrajudicial proceedings