Law on Medical Products
The principal legal framework comprises Regulation (EU) 2017/745 on medical devices (MDR), Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), and the German Medical Devices Implementation Act (MPDG). Product liability, advertising and unfair competition law may also apply.
Requirements for manufacture, conformity assessment and distribution depend on the intended purpose, risk class and economic operator’s role. Transitional provisions must be assessed for each product. Medical devices should not be described as invariably easier to bring to market than medicinal products.
Advertising and marketing of medical devices
Placing on the market a medical product and its advertisement is better if legally supported. For this reason, we carry out the following legal services in medical products law:
- General consultation on medical product law,
- Advice and representation on individual questions concerning the MDR, IVDR and MPDG
- Marketability examination of medical products and their qualification as medical devices,
- Distribution law for medical products (GTC law, labelling requirements, CE marketing, EU distribution and non-European distribution),
- Work regulations for medical devices producers,
- Contract manufacturing of medical products,
- Certification procedures, conformity procedures, consultation procedures etc.,
- MDR, IVDR, MPDG, German Therapeutic Products Advertising Act (HWG) and German Act against Unfair Competition (UWG)
