Information - Services - Formalities by subjects - Anlagen, Waren und Stoffe - Verbraucherschutz - Technical consumer protection; registration of economic operators - Dienstleistungsportal Bayern

Description

On 1 December 2020, the European Commission (COM) launched the first of the six planned modules of the European Database for Medical Devices (EUDAMED) for "Actor Registration". This module will allow concerned companies as well as competent authorities to comply with their registration obligations described in Article 31 of Regulation (EU) 2017/745 (MDR).

All economic operators (manufacturers, authorised 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).

Procedure

The registration of manufacturers, authorised representatives and importers as well as the allocation of the Single Registration Number (SRN) is carried out by the respective competent authority via the EUDAMED module called "Actor Registration", which has been released by the European Commission (for link see "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, and the governments of Upper Bavaria and Upper Franconia (pharmaceutical departments) are responsible as enforcement authorities.

Required documents

• 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

Forms

• Form, Bavaria-wide: Erklärung zur Informationssicherheit (liegt in verschiedenen Sprachen vor)

  Please note

  This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.

• Form, Bavaria-wide: Zusammenfassung des Mandats zwischen einem Drittstaathersteller und seinem Bevollmächtigten (Mandate Summary template for the registration in EUDAMED)

  Please note

  This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.

  (englische Version)

Online procedures

• Europäische Datenbank für Medizinprodukte - EUDAMED

  Economic operators can register in the European Database for Medical Devices (EUDAMED) via the "Actors Registration" module.

Legal bases

• Verordnung (EU) 2017/745 - Europäische Medizinprodukteverordnung (MDR)
• Gesetz zur Durchführung unionsrechtlicher Vorschriften betreffend Medizinprodukte (Medizinprodukterecht-Durchführungsgesetz - MPDG)

Links to more information

• Marktüberwachung - Aufgaben und Befugnisse der Behörden

  Informationen der Bayerischen Gewerbeaufsicht

• Deutsches Medizinprodukte-Informations- und Datenbanksystem (DMIDS)

  Informationen des Bundesinstituts für Arzneimittel und Medizinprodukte

• Medical Devices - EUDAMED
• Regierung der Oberpfalz - Gewerbeaufsichtsamt

Related issues

• Medical devices; monitoring of operators
• Technical consumer protection; market surveillance of active medical devices
• Technical consumer protection; market surveillance Product safety
• Technical consumer protection; market surveillance of in vitro diagnostic medical devices
• Technical consumer protection; registration of active medical devices