EUDAMED Company Registration and User Management
The European Commission has stated that December 1st 2020 MDR EUDAMED will go live for economic operators to register on a voluntary basis. Early registration is recommended to receive your SRN as soon as possible. Receiving your SRN means you can prepare your MDR required labelling designs and your certificates can be completed by displaying the SRN. Click for the EC decision.
All economic operators are obliged to register. Medical device Manufacturers, Authorised Representatives, Importers, and System or Procedure Pack Producers must register. If your company holds more than one of these roles then you must register multiple times, once per role and you will receive multiple SRN’s.
For non-EU companies, your selected Authorised Representative must register before you so please ensure they are aware of the EUDAMED dates.
Our annual registration subscription service includes EUDAMED role registration, user base management, adding/removing of the person(s) responsible for regulatory compliance, and ongoing company information and communication preferences management.
Note: Some competent authorities are charging for the EUDAMED validation process, for any costs invoiced to Eudamed.eu for company validations we will invoice the registering company plus the credit card processing fee. These competent authority fees are completely beyond our control. For example, Swiss Medic have stated “Fees for validating SRN and the required proof documents will be billed on the basis of the work involved in accordance with Art. 4 FeeO-Swissmedic. The hourly rate for the fee according to expenditure is CHF 200 in accordance with Art. 4 Para. 2 FeeO-Swissmedic. For manufacturers domiciled outside the Union, the cost of assigning an SRN will be billed to the mandated authorised representative.”
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