Economic operators (manufacturers, authorized representatives, importers and distributors) may only make safe medical devices 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 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 requirements of EU law and the European standards that govern the free movement of goods in the internal market.
In order to ensure that only safe medical devices 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 reports of incidents and complaints,
- withdraws unsafe medical devices from circulation,
- controls relevant economic actors by means of inspections,
- inspects medical devices at trade fairs and exhibitions and in the trade (including online trade) by means of targeted spot checks,
- participates as a consumer protection authority in the Europe-wide EU rapid information system.
The product spectrum is large, ranging from simple blood pressure measuring devices to software applications "medical apps" and highly complex medical equipment.
If you have questions about requirements for active medical devices, or suspect that an active medical device does not meet the prescribed requirements, you can contact the Trade Inspectorate at the Government of Upper Palatinate directly.
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