July, 2026: Brussels. The EUDAMED registration mandatory requirements for all medical device and IVD manufacturers began without much fanfare on 28 May 2026. Last November, according to Commission Decision 2025/2371, the European Commission confirmed that the first four EUDAMED modules are fully functional. According to that decision, all Economic Operators – manufacturers, authorised representatives, clinical investigation and (IVD) performance study sponsors, importers, and system and procedure pack producers needed to be registered with EUDAMED by 28 May 2026. EUDAMED registration includes:
- Registering via the Actor module
- If applicable, verification by the (registered) Authorised Representative, or relevant Competent Authority
- Obtaining a Single Registration Number (SRN)
In addition, depending on when the device is/was placed on the market, the manufacturer may need to obtain an EU UDI (not necessarily the same as the FDA UDI) number and register it in the UDI/Device module before placing on the EU Market. For legacy devices on the market prior to 28 May 2026, you have until 28 November 2026. For all new devices placed on the market on or after 28 May 2026, the EU UDI needs to be registered in the UDI/Device Module as of 28 May 2026.
If you currently manufacture legacy devices and still market or import them to the EU under the transitional provisions of the MDR/IVDR, but have not yet completed EUDAMED Actor registration, your Notified Body may issue a major NC for failure to comply with applicable regulatory requirements.
If you registered with EUDAMED prior to 28 May 2026, but have not obtained the SRN, or have released any new MDR or IVDR products into the EU on or after 28 May 2026 without registering them in the UDI/Device module, Competent Authorities may take enforcement action.
CRO Group is ready to assist you in implementing all applicable mandatory requirements, as well as in providing training, conducting internal assessments, and generating overall plans so that you don’t get ‘swamped’ during your MDR/IVDR journey. For more information, on available, please click here – or to obtain a quote, please click here.