Technical consumer protection; market surveillance of in vitro diagnostic medical devices

The mission of the Trade Supervisory Office at the Government of Upper Palatinate is to ensure safe products in the area of technical consumer protection. This includes, among others, active (dependent on an energy source) in-vitro diagnostics.

Description

Economic operators (manufacturers, authorised representatives, importers and distributors) shall only make available on the market safe in vitro diagnostic medical devices (IVDs). They are responsible for ensuring that their products are such as to protect users and third parties 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 the EU legal requirements and the European standards which are decisive for 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. The IVDR is mandatory from 26 May 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 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 EU-wide 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.

Special notes

The Bavarian State Ministry of Health and Care is responsible for monitoring the placing on the market of non-active medical devices, and the governments of Upper Bavaria and Upper Franconia (pharmaceutical departments) are responsible as enforcement authorities.

Status: 05.11.2021

Responsible for editing: Bayerisches Staatsministerium für Umwelt und Verbraucherschutz

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  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
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