The EU has just turned a corner in the medical device regulatory journey. Two legal instruments: Regulation (EU) 2024/1860 and the recent Commission Decision (EU) 2025/2371, together move EUDAMED from a long-in-the-making database into operational reality. This transition sets timelines and the way economic operators, notified bodies and competent authorities interact. Let’s break down the key elements: the essentials, practical implications and pragmatic next steps.
Regulation (EU) 2024/1860 amended the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) to allow a phased roll-out of EUDAMED and to introduce certain transitional and supply-continuity measures.
Commission Decision (EU) 2025/2371, published in the Official Journal of the European Union (OJEU) on 27 November 2025, formally confirms that the first four EUDAMED modules: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates and Market Surveillance, meet the established functional specifications. Publication in the OJEU triggered a six-month transition period – mandatory use therefore begins 28 May 2026.
This shift introduces enforceability for the four modules that are ready now, while leaving more complex pieces (Vigilance/PMS and Clinical Investigations/Performance Studies modules) to come live later.
Manufacturers | Authorised Representatives | Importers | System and Procedure Pack Producers
With most actors already registered and holding SRNs, the requirement becomes fully non-optional: any economic operator not yet registered must do so before placing devices on the market after 28 May 2026.
New devices placed on the market after the mandatory use date must be entered in the UDI/Device module prior to first placement. Devices already on the market have defined windows for registration (we’ll explore this further in the next section).
Certificates issued after the mandatory use date must be uploaded into EUDAMED immediately. For certificates existing prior to the enforceable date, Notified Bodies are given a defined period to populate information in EUDAMED.
Competent Authorities & Market Surveillance
Market surveillance tools will now leverage centralised actor, device and certification data. Accurate, timely submissions by economic operators will be essential for efficient oversight.
Here is a table summarising the first four EUDAMED modules and the associated timelines for different device categories: ‘Regulation devices’ (devices under MDR/IVDR) and ‘legacy/Directive devices’ (MDD/AIMDD/IVDD), whether already on the market or newly placed on the market.
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EUDAMED Module and Mandatory Use Date |
Obligation – New Regulation Devices placed on market after mandatory date |
Obligation – Regulation Devices already on the market at mandatory date |
Obligation – Legacy/Directive Devices still placed on the market after mandatory date |
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Actor Registration 28 May 2026 |
All economic operators (MF, AR, IM, SPPP) must register and obtain SRN before placing devices on the market. |
Must register (if not already) before the mandatory date to cover continued activity. |
Likewise, must register (if not already) if continuing to market devices post‑mandatory date. |
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UDI / Device Registration 28 May 2026 |
Registration before first placing on the EU market. |
Devices already on the market at that date must be registered within 12 months after OJEU notice (by 28 November 2026) if they will continue to be placed on the market. |
If the “same device” (shared UDI-DI, catalogue number / trade name, same characteristics) is already registered under MDR/IVDR, no separate registration is required. Otherwise, registration within 12 months after OJEU notice. |
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Notified Bodies & Certificates 28 May 2026 |
Certificates issued after mandatory date must be registered in EUDAMED immediately (as part of conformity assessment workflow). |
Certificates existing before mandatory date must be uploaded within 18 months after OJEU notice (by 28 May 2027). This concerns their latest revision and subsequent decisions, if relevant. |
For legacy devices under old directives with no new MDR/IVDR certificate, registration of certificates is not required. |
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Market Surveillance 28 May 2026 |
Competent authorities will use MS module for market surveillance tasks. From Economic Operator perspective, this does not impose new obligations beyond actor / device / certificate registration. |
Economic Operators must ensure that their data (actors / devices / certificates) is valid. |
Legacy devices continuing to be placed on the market must have adequate registration entries. |
Regulation 2024/1860 addressed other regulatory concerns beyond EUDAMED. It extended transitional periods for certain in vitro diagnostic devices that had not yet obtained conformity under IVDR. This measure was motivated by concerns over insufficient notified bodies capacity and the risk of supply shortages for critical IVDs. Manufacturers should re-check whether their specific devices benefit from extended timelines and plan accordingly.
Practical checklist
Even with careful planning, the phased rollout of EUDAMED introduces several areas where challenges may arise. Here are potential points of vulnerability that stakeholders should anticipate and address proactively to avoid delays or compliance issues.
Regulation (EU) 2024/1860 and Commission Decision (EU) 2025/2371 move EUDAMED from a voluntary use to an operational requirement for the first four modules. The publications introduce a cascade of deadlines and interdependencies that require focused project planning.
28 May 2026 is a firm compliance checkpoint – now’s a good time to make sure your SRN, UDI and certificate workflows are in order.
Navigating EUDAMED compliance can be demanding. Qserve helps economic operators and notified bodies:
We’re here to assist – reach out if you need help with compliance or regulatory intelligence.