Registration for the EUDAMED Single Registration Number Services (SRN Eudamed) for the 27 countries of the European Union, Iceland, Liechtenstein and Norway is underway as of 1 December.
As we told you in our blog, EUDAMED (European database on medical device) is the database of information on medical devices developed by the European Commission. In addition, the competent national authorities of other countries may be registered from a later date.
HOW TO OBTAIN YOUR EUDAMED SRN FOR YOUR COMPANY AS A MANUFACTURER, IMPORTER OR AUTHORISED REPRESENTATIVE OF MEDICAL DEVICES?
EUDAMED is divided into two parts, one with private information and one with public information, and is composed of five modules related to:
- registration of agents
- product registration and UDI
- notified and certified bodies,
- clinical assessments and assessment of functioning
- post-market surveillance and monitoring activities
To register as an economic operator of medical devices, you must first apply for the SRN (Single Registration Number) to be included in the database. From there, two different paths can be followed. It all depends on whether the operator belongs to the EU or not, as detailed in the Commission’s recently published quick guide.
Once the economic operator is registered as an operator, indicating whether he is a manufacturer, authorised representative or importer, the information requested by the system has to be added.
The documents attached to the operator registration application will be based on a PDF template available on the EUDAMED medical device sector website. The Commission provides a user guide for economic operators and the CA quick guide, as well as infographics.
Read More About: GUDID Services
WHO ARE CONSIDERED ECONOMIC OPERATORS?
A medical device economic operator is an EU manufacturer, procedure kit manufacturer, authorised representative and importer of both medical devices and in vitro medical devices.
However, according to the Commission, non-EU manufacturers will only be able to register if their authorised representative is established in one of the 27 EU countries, Iceland, Liechtenstein or Norway.
Economic operators from the UK, Switzerland and Turkey will only be able to submit applications at a later stage after December 2020 and once their authorised representative has completed their registration.
It should be considered that the same legal entity may use several trade names. In such a case the registration is made separately for each of their names. Although each manufacturer will have only one SRN for each trade name, there is no limitation on the number of importers that can be linked to a manufacturer.
Distributors, on the other hand, cannot register with EUDAMED because there is no operator role for the distributor and therefore no SRN for them.