Navigating through the various provisions in this product category is no easy task. Meanwhile, the law lays out numerous requirements towards products marketed under the designation of “medical device” and the sanctions for failing to fulfil them are very severe. You need legal assistance.
Learn how we can support your business! What do we do?
- We consult in scope of qualifying a product as a “medical device” (borderline products)
- We verify and consult the product class
- We evaluate and prepare product labels
- We provide recommendations concerning product marketing communication
- We handle the medical device notification procedure
- We handle administrative processes, court and administrative processes, and court processes concerning medical devices
- We draft responses to complaints