👉 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