The Eudamed database is a European regulation and can apply without any national transposition needed. There are clear instructions in the MDR about the application and transition of EUDAMED, however, the MDR will function without Eudamed.
Eudamed has been made available on a voluntary basis, but it is not required.
According to Article 34 (3)
“3. The Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European Union.”
The following is missing for Eudamed to be mandatory:
- It needs to be fully functional
- It needs to be validated
- It needs to be published in the Official Journal of the EU.
Publication of a fully functional Eudamed is planned in 2022
In addition, once it is published, the registration of actors (Article 31) shall apply even six months after the implementation of Eudamed. This is provided by Article 123 (d):
“ … the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3). The provisions referred to in the preceding sentence are: …
The German Ministry (BMG) issued a statement that the applicable Competent Authorities (CA) should not issue the SRN. They see significant legal uncertainties with the voluntary release of Eudamed.
The BMG first wants to clarify all aspects, validate the system and implement legal provisions. Whether these will be voluntary or mandatory may have to be seen. The earliest this may happen is May 26, 2021.
The SRN, or even the whole Eudamed, is not needed for the MDR to function. For example, certificates are now issued on a daily basis by the Notified Bodies without the SRN and according to the wording in Annex IV:
“ANNEX IV EU DECLARATION OF CONFORMITY The EU declaration of conformity shall contain all of the following information: 1. Name, registered trade name or registered trade mark and, if already issued, SRN as referred to in Article 31 …“
Therefore, if the SRN is not issued, then you do not- or for that matter, you cannot - disclose the SRN on any DOC. However, even if it already applies, you will not have to do it immediately.
Here is the MDCG document.
MDSS monitors the developments and will inform clients immediately.