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Medical devices; monitoring of operators
The trade supervisory authorities inspect the operation of medical-technical devices.
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Forms
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Anzeige über die Durchführung messtechnischer Kontrollen
This form can be submitted electronically without signature (e.g. via a secure contact form or by e-mail) or in paper form to the responsible authority.
Responsible for you
Regierung der Oberpfalz - Dezernat 22 - Betriebssicherheit, Strahlenschutz, Medizinprodukte Betreiben, Arbeitsschutzmanagementsysteme
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Street address
Emmeramsplatz 8
93047 Regensburg
Postal address
Emmeramsplatz 8
93047 Regensburg
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Standort im BayernAtlas
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Procedure details
Description
It is the task of the trade supervisory authorities at the governments to ensure that neither users nor patients are endangered by the use of medical devices.
The trade supervisory authorities
- monitors the proper cleaning, disinfection and sterilization of used instruments and devices before they are used again.
- monitors the performance of technical inspections (safety inspections) of certain "active" (energy-operated) medical devices (e.g. mechanical ventilators, magnetic resonance devices).
- monitors the performance of metrological checks on certain medical devices with a measurement function (e.g. blood pressure monitors) to ensure that the measurement accuracy is within specified error limits.
- monitors the documentation obligations of operators, such as keeping an inventory or medical device books.
Legal bases
Appeal
Administrative Lawsuit
Related links
Related issues
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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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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.
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UV irradiation equipment; monitoring of operatorsThe trade supervisory authorities inspect the operation of tanning salons.
Status: 09.04.2025
Editorially responsible for prodecure description: Bayerisches Staatsministerium für Umwelt und Verbraucherschutz
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