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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.
Online services & Forms
Online services
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Europäische Datenbank für Medizinprodukte - EUDAMEDEconomic operators can register in the European Database for Medical Devices (EUDAMED) via the "Actors Registration" module.
Forms
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Erklärung zur Informationssicherheit (liegt in verschiedenen Sprachen vor)
This form can be submitted electronically (e.g. via a secure contact form using your user account with login via the electronic ID function or the ELSTER certificate) or handwritten and signed in paper form to the responsible authority.
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Zusammenfassung des Mandats zwischen einem Drittstaathersteller und seinem Bevollmächtigten (Mandate Summary template for the registration in EUDAMED)(englische Version)
This form can be submitted electronically (e.g. via a secure contact form using your user account with login via the electronic ID function or the ELSTER certificate) or handwritten and signed in paper form to the responsible authority.
Responsible for you
Regierung der Oberpfalz - Dezernat 4 - Kompetenzzentrum Marktüberwachung
Secure contact form
Street address
Emmeramsplatz 8
93047 Regensburg
Postal address
Emmeramsplatz 8
93047 Regensburg
Phone
Opening hours
Standort im BayernAtlas
Route planner
Timetable for public transport
Procedure details
Description
On December 1, 2020, the European Commission (COM) activated the first of the six planned modules of the European Database for Medical Devices (EUDAMED) for "Actor Registration". This module enables the companies concerned and the competent authorities to fulfill their registration obligations as described in Article 31 of Regulation (EU) 2017/745 (MDR) and Article 28 of Regulation (EU) 2017/746 (IVDR) .
All economic operators (manufacturers, authorized representatives and importers) must register in EUDAMED before placing active medical devices (dependent on an energy source) on the market for the first time (dispensing against payment or free of charge).
Required documents
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Required Documents:
- Document identifying the organization
- current extract from the commercial register or
- document assigning the VAT number (Value Added Tax Identification Number) or
- Document assigning the EORI number (Economic Operators' Registration and Identification number)
- Information Security Declaration
The signed Information Security Declaration must be uploaded in EUDAMED as part of the application process. - Third country manufacturers only: Summary of the mandate of the authorised representative
- Document identifying the organization
Proceedings
The registration of manufacturers, authorized representatives and importers as well as the assignment of the Single Registration Number (SRN) is carried out by the respective competent authority via the EUDAMED module called "Actor Registration" activated by the European Commission (see link under "Online procedure").
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.
Legal bases
Related links
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Marktüberwachung - Aufgaben und Befugnisse der BehördenInformationen der Bayerischen Gewerbeaufsicht
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Deutsches Medizinprodukte-Informations- und Datenbanksystem (DMIDS)Informationen des Bundesinstituts für Arzneimittel und Medizinprodukte
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 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; 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.
Status: 22.10.2024
Editorially responsible for prodecure description: Bayerisches Staatsministerium für Umwelt und Verbraucherschutz
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