🔄 Update (29 October 2026): 28 May 2026 has now passed, so registration in the EUDAMED actors module described below is already mandatory rather than an upcoming deadline. If your company has not yet registered or obtained its SRN, do not delay any further. We summarise the status of the mandatory modules in the news item EUDAMED mandatory since 28 May 2026. The November deadline for devices already on the market is explained in our EUDAMED registration guide. If you have any questions about your case, write to us at info@medev.es.
👉 This is the page for mandatory registration: EUDAMED release 2.27.0.
🔗EUDAMED actors 🔗EUDAMED public site
The main new features are:
– The Market Surveillance module
– The Clinical Evaluation Consultation Procedure (CECP) function in the Notified Bodies and Certificates module
– The Mechanism for Scrutiny (MfS) function in the Notified Bodies and Certificates module.
👀All economic operators:
– Medical device manufacturers (“legal” manufacturers; contract manufacturers producing for third parties are not included) – Require a prior AEMPS licence
– Medical device importers (“legal” importers; physical importers are not included) – Require a prior AEMPS licence
– Manufacturers of Class III custom-made devices – Require a prior licence from the CCAA (Spanish regional authorities)
– Producers of systems and procedure packs – Require a prior AEMPS licence
– EU-REP – do not require an AEMPS/CCAA licence
⚠️must register in the EUDAMED actors module before 28 May 2026
⚠️✔︎ For strategic regulatory consultancy, training and direct support in using the EUDAMED modules, the experts at MeDev Consulting are at your side. Contact us at: info@medev.es