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Technical consumer protection; market surveillance of active medical devices
The task 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 active medical devices (dependent on an energy source).
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Regierung der Oberpfalz - Dezernat 4 - Kompetenzzentrum Marktüberwachung
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Emmeramsplatz 8
93047 Regensburg
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93047 Regensburg
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Description
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 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.
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 incident reports and complaints,
- withdraws unsafe medical devices from circulation,
- controls relevant economic operators by means of inspections,
- inspects medical devices at trade fairs and exhibitions and in retail (including online retail) by means of targeted spot checks,
- participates as a consumer protection authority in the Europe-wide EU Rapid Information System.
The product spectrum is wide, ranging from simple blood pressure monitors to software applications "medical apps" and highly complex medical systems.
If you have any questions about the requirements for active medical devices, or if you suspect that an active medical device does not meet the prescribed requirements, you can contact the Trade Supervisory 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, as are the governments of Upper Bavaria and Upper Franconia (Pharmacy departments) as enforcement authorities.
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Related links
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Marktüberwachung - Aufgaben und Befugnisse der BehördenInformationen der Bayerischen Gewerbeaufsicht
Related issues
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Medical devices; monitoring of operatorsThe trade supervisory authorities inspect the operation of medical-technical devices.
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Technical consumer protection; implementation of product safety measuresThe task of the trade supervisory authorities at the governments of Middle Franconia and Upper Bavaria is to ensure safe products in the area of technical consumer protection.
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Technical consumer protection; market surveillance Ecodesign / energy consumption labeling
The Trade Supervisory Office at the Government of Swabia is responsible for monitoring environmentally friendly design (ecodesign) and energy consumption labeling.
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Technical consumer protection; market surveillance of in-vitro diagnostics
The task 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 active (energy-dependent) in-vitro diagnostics.
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Technical consumer protection; registration of active medical devicesManufacturers who wish to place active medical devices on the market must first provide them with a Unique Device Identification (UDI) and register them in the UDI database.
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Technical consumer protection; registration of economic operators
Manufacturers, authorized representatives and importers (importers) of medical devices must register via the electronic system for the registration of economic operators (EUDAMED) before placing a product on the market.
Status: 22.10.2024
Editorially responsible for prodecure description: Bayerisches Staatsministerium für Umwelt und Verbraucherschutz
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