The EUDAMED is the European database for medical devices . However, it is not only used to manage medical devices.

The Medical Device Regulation (MDR) relies on EUDAMED and defines which requirements must be stored in this database.

These regulations affect the work of manufacturers as well as those of authorities and notified bodies.

1. What purpose the EU is pursuing with EUDAMED

The EUDAMED is based on a decision of the EU Commission ( 2010/227 / EU). In it the EU formulates the purpose of EUDAMED:

“The European database for medical devices aims to improve market surveillance by giving competent authorities quick access to information on manufacturers and their authorized representatives, on products and certificates and on vigilance data; It is also intended to contribute to the exchange of information on clinical trial data and to the uniform application of the above guidelines, in particular with regard to the reporting requirements. "

This decision from April 2010 coincided with the ban on breast implants from the manufacturer PIP ( more on the PIP scandal ).

2. Regulatory requirements

The Medical Device Regulation MDR obliges manufacturers to store data about themselves and their products in EUDAMED:

  • Article 31 (1): “Before [ manufacturers, authorized representatives, importers ] place a product […] on the market, [they] enter the information specified in Annex VI, Part A, Section 1 into the electronic system referred to in Article 30 in order to obtain information register, unless you have already registered under this article. [...] "
  • Article 29 (4): “Before a product […] is placed on the market, the manufacturer shall enter the information specified in Annex VI, Part A, Section 2 - with the exception of Section 2.2 - in Eudamed or, if it has already been entered, check it , after; then he keeps this information up to date. "

For class III products and implants, Article 32 also requires a summary of safety and performance to be set in EUDAMED. The database should also be (partially) accessible to the public.

3. Data stored in the EUDAMED

The above EU decision also specifies which data the EUDAMED must save:

a) Actor (manufacturer, authorized representative)
  • ID (more on this below)
  • Surname
  • Street
  • location
  • Postal code
  • country
  • Telephone number or email address
b) product
  • Product Code
  • Product name, make
  • According to Article 24 and Annex V Part A, Section 2, the MDR also requires UDI , risk class, reusable product (y / n), with animal or human tissue (y / n), etc.
c) Certificate
  • Certificate number
  • Type of certificate
  • date of issue
  • End of validity
  • Manufacturer and, if applicable, authorized representative (see fields under "Actor")
  • Notified body (selected from the system)
  • General description of the validity and, if applicable, details of the product (see fields under point

    ...

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