Once the EUDAMED ‘Stakeholders’ module becomes fully mandatory, it will be necessary to have a SRN (Single Registration Number) It will no longer be optional and will become an essential requirement for marketing medical devices in the European Union.
This represents a key change to the regulatory framework set out in Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), which strengthens the traceability, transparency and safety of medical devices across the European market.
What happens if you don’t have an SRN?
The absence of an SRN by the time the system becomes fully mandatory will have direct and critical consequences for economic operators:
Loss of market access: Distributors, importers and healthcare centres will not be permitted to work with non-compliant operators, which may result in the direct loss of customers and contracts.
Suspension of trading on the European market: Without an SRN, manufacturers, importers and authorised representatives will not be able to operate legally within the system EUDAMED, thereby falling outside the scope of European regulatory framework.
Customs and supply chain issues: Medical devices may be detained or rejected at the border if there is no registered entity associated with them in EUDAMED.
Non-compliance with the MDR/IVDR: Without registration on EUDAMED, it is not possible to comply properly with essential obligations such as UDI traceability, post-market surveillance or communication with the competent authorities.
Risk of penalties: Member States may impose corrective measures, administrative penalties and even marketing bans in the event of non-compliance.
What exactly is it, and who is required to register?
The Single Registration Number (SRN) It is the unique identifier assigned by EUDAMED to each registered economic operator. This number serves as the “regulatory identity” within the European medical devices system.
Without it, an economic operator cannot be officially recognised in the EU market.
They must have an SRN:
- Manufacturers of medical devices and IVD products (within and outside the EU)
- Authorised representatives of non-European manufacturers
- Importers of medical devices in the EU
- Manufacturers of systems and procedure packs
An obligation that marks a turning point
The mandatory implementation of EUDAMED represents a structural change in European regulation. The SRN has become the first essential step for any economic operator wishing to continue marketing medical devices in the EU.
In addition to the mandatory nature of the ‘Stakeholders’ module, it is important to remember that EUDAMED comprises other modules that are fundamental to the life cycle of a medical device, such as UDI registration, notified body certificates, clinical investigations and market surveillance. Staying up to date with the implementation deadlines for each of these will be crucial for all companies in the sector in the coming years.
How should you prepare before the deadline?
With a view to 28 May 2026, economic operators who do not yet have an SRN should begin the EUDAMED registration process as soon as possible, as it may take several weeks for the competent authority to validate the application. Recommended steps include: checking whether the company already has a prior registration in any of the EUDAMED modules; gathering the necessary corporate and legal representation documentation; correctly designating the organisation’s role (manufacturer, authorised representative, importer or producer of systems and procedure packs) and keeping the contact details and those of the person responsible for regulatory compliance up to date.
Having access to specialist advice on the regulation of medical devices can significantly speed up this process and help avoid mistakes that might delay the issue of the registration number.
Getting ahead of the SRN’s mandatory implementation not only avoids penalties and trade barriers, but also provides a competitive advantage: operators who are already registered will be able to continue operating without disruption, build trust with distributors and healthcare facilities, and devote time to adapting to the other requirements of the MDR and the IVDR, rather than having to manage the registration process under last-minute pressure.
CONCLUSION
Failing to hold an SRN when EUDAMED becomes mandatory is not merely an administrative offence: it is a direct barrier to access to the European market.
Advance preparation is key to avoiding blockages, penalties and disruptions to business operations.
If you’re not sure whether you have it or would like to apply for it, please don’t hesitate to contact us https://mcamps.com/contacto/ We’ll help you through the process.
Mercè Camps Miró