Economic operators (manufacturers, authorized representatives, importers and distributors) may only make safe in vitro diagnostic medical devices (IVDs) available on the market. They are responsible for ensuring that their products are designed in such a way that users and third parties are protected from risks to life and health. This is a significant contribution to the preventive protection of consumers and patients. The safety standard is based on EU legal requirements and European standards, which are decisive for the free movement of goods in the internal market. The European Regulation on In Vitro Diagnostic Medical Devices (IVDR) is relevant for in-vitro diagnostics. The IVDR has been mandatory since 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 supervisory authority
- investigates incident reports and complaints,
- withdraws unsafe in-vitro diagnostics from circulation,
- controls relevant economic operators by means of inspections,
- checks in-vitro diagnostics at trade fairs and exhibitions and in retail (including online retail) 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 the 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 Supervisory Office at the Government of Upper Palatinate directly.
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