Economic operators (manufacturers, authorized representatives, importers and distributors) may only make safe in vitro diagnostic (IVD) devices available on the market. They are responsible for ensuring that their products are such that users and third parties are protected from hazards to life and health. This is a significant contribution to the preventive protection of consumers and patients. The safety standard is based on the EU legal requirements and the European standards that govern the free movement of goods in the internal market. For in vitro diagnostic medical devices, the European Regulation for In Vitro Diagnostic Medical Devices (IVDR) is relevant. Application of the IVDR is mandatory as of May 26, 2022.
In order to ensure that only safe IVDs that meet the high European standards are placed on the market (i.e. reach the consumer / patient), the Bavarian Trade Inspectorate performs the following tasks in particular.
The Trade Inspectorate
- investigates incident reports and complaints,
- withdraws unsafe in vitro diagnostic products from circulation,
- controls relevant economic actors by means of inspections,
- controls in-vitro diagnostics at trade fairs and exhibitions and in trade (including online trade) by means of targeted spot checks, and
- participates as a consumer protection authority in the Europe-wide EU rapid information system.
If you have any questions about requirements for active in vitro diagnostic medical devices, or if you suspect that an active in vitro diagnostic medical device does not meet the prescribed requirements, you can contact the Trade Inspection Office at the Government of Upper Palatinate directly.