The European Database on Medical Devices (“EUDAMED”) was conceived as the central structural and governance instrument of European medical device law and was intended to serve as a Union-wide database for medical devices and in vitro diagnostic devices (“IVD”), creating transparency, strengthening market surveillance, and replacing the fragmented reporting and information systems of the Member States. Since the entry into force of Regulation (EU) 2017/745 on medical devices (“MDR”) on 26 May 2021 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”) on 26 May 2022, EUDAMED has been, at least conceptual, the digital backbone of the European medical device regime.
For years, the regulatory reality was characterised by a tension: on the one hand, MDR and IVDR established far-reaching obligations that explicitly hinged on the use of EUDAMED; on the other hand, the database was not fully available from a technical and functional perspective. The European legislator responded with transitional solutions, optional use of individual modules, and the toleration of national reporting channels. For economic operators concerned, this resulted in legal uncertainty, parallel structures, and a significant additional administrative burden.
With the Commission’s confirmation of the functionality of EUDAMED Modules 1, 2, 3 and 5, adopted as Commission Decision (EU) 2025/2371 of 26 November 2025, a years-long state of suspension has come to an end. What for years was perceived as a fragmented IT project has now been granted the legal status that marks the transition from voluntary use to mandatory application. The declaration of functionality is more than a technical progress report; it is a normative act. With the publication of the declaration of functionality in the Official Journal of the European Union on 27 November 2025, the six-month transitional period laid down in Article 123(3)(d) to (ec) MDR and Article 113(3)(f) to (fd) IVDR is triggered. Upon its expiry, as of 28 May 2026, the use of these four modules becomes mandatory—entailing far-reaching consequences for manufacturers, authorised representatives, importers, notified bodies and, not least, market surveillance authorities. EUDAMED thus moves from a phase of regulatory provisionality into a phase of binding application.
Module 1: Registration of (Economic) Operators
Module 1, which concerns the registration of economic operators, forms the foundation of EUDAMED. It answers the seemingly banal, yet legally central, question of who is actually participating in the European medical device market. Manufacturers, authorised representatives, importers (but not distributors) and—within specific roles—also notified bodies are assigned a unique electronic identity.
The legal basis is found in Article 30 MDR and Article 27 IVDR. Registration is a prerequisite for virtually any further interaction with the system. Without a Single Registration Number (SRN), neither products nor certificates can be lawfully represented in EUDAMED.
For manufacturers, this means that corporate structures can no longer be mapped informally or pragmatically. Intragroup role allocations, contract manufacturing arrangements or EU establishments must be assigned in a regulatorily unambiguous manner. The SRN thus becomes the point of reference for legal responsibility, for example in the context of recalls, safety measures or administrative orders.
Authorised representatives and importers likewise move more strongly into the spotlight. MDR and IVDR deliberately enhanced their role. For authorised representatives and importers, the focus shifts from a mere contractual relationship towards independent regulatory visibility, with the consequence that compliance deficits can no longer be concealed within supply chains. Incorrect registrations or delayed updates are not merely formal infringements, but may give rise to liability and administrative fines. The functionality of this module therefore definitively removes the ground from the previous practice of regulatory invisibility.
Distributors or importers who carry out an activity within the meaning of Article 16(1) MDR/IVDR that has an impact on the conformity of the products are subsequently subject to the obligations addressed to manufacturers under the MDR/IVDR, including the obligation to register in EUDAMED as a manufacturer. Where the activities concerned do not result in a modification of the medical device/IVD, cf. Article 16(2) MDR/IVDR, the obligation of the responsible distributor or importer to register as a manufacturer does not apply. For importers (but not distributors), however, the general obligation under Article 31 MDR or Article 28 IVDR to register as an economic operator in Module 1 remains applicable even in this case.
Caveat: EUDAMED Module 1 has already been mandatory at national level for German manufacturers, authorised representatives and importers of medical devices since 26 May 2021, based on the notification of the Federal Ministry of Health (notification pursuant to Section 97 MPDG of 26 May 2021, Federal Gazette AT of 28 May 2021 B6), and, in case of IVDs, since 26 May 2022 (notification pursuant to Section 96a MPDG of 16 May 2022, Federal Gazette AT of 27 May 2022 B4). For economic operators established in other EU Member States, any existing national transitional provisions that already mandated registration in Module 1 prior to the present communication on the functionality of EUDAMED must therefore also be taken into account.
Module 2 – UDI and Product Registration as a Market Access Prerequisite
The second functional module concerns UDI and product registration pursuant to Articles 28 and 29 MDR and Articles 25 and 26 IVDR and shifts the regulatory focus from the operator to the product itself. UDI and product registration make visible which medical devices and IVDs are placed on the market, in which configurations they are offered, and how they can be uniquely identified. In this way, a core objective of the MDR/IVDR is operationalised: seamless traceability throughout the entire lifecycle.
For manufacturers, this constitutes a substantial structural challenge—and it is a heavy workload. Product portfolios must be prepared at a granular level, Basic UDI-DIs must be assigned consistently, and changes must be tracked throughout the entire product lifecycle. The data requirements go far beyond what has previously been maintained in national registers or internal systems. EUDAMED does not function merely as an archive, but as an active regulatory control instrument.
Transitional periods play a central role here. For legacy medical devices that were already placed on the market with a specific UDI-DI before 28 May 2026, the transitional provisions of Article 123(3)(e) MDR apply. These products are subject to a transitional period of 12 months and must therefore be entered into the UDI product module by 27 November 2026 if they are to continue to be distributed with that UDI-DI beyond that date.
Caveat: Pursuant to Article 113(3)(fa) IVDR, a transitional period of six months applies to legacy IVDs, meaning that they must be registered in Module 2 by 27 May 2026.
This module also has implications for importers and distributors. The obligation to verify product registration under Articles 13(2)(d) and 14(2)(d) MDR/IVDR is no longer theoretical, but can be verified by importers and distributors using the database. Market surveillance authorities gain an instrument to efficiently identify the placing on the market of unregistered products. For companies, this increases the risk of being held accountable for omissions in upstream supply chains.
Module 3 – Certificates (and Notified Bodies) in the Digital Shop Window
With Module 3 for notified bodies and certificates, a previously confidential area of the conformity assessment procedure becomes publicly traceable. The legal basis is Article 57 MDR and Article 52 IVDR. Certificates, their period of validity, restrictions, suspensions or withdrawals become visible through EUDAMED.
For manufacturers, this significantly alters the strategic starting position. Certificates are no longer merely bilateral documents between the company and the notified body, but part of a transparent system. Delays in recertification or conditions imposed by notified bodies can no longer be managed discreetly. They become part of a publicly accessible system that can be used alike by authorities, market participants and competitors.
Legacy certificates must also be entered into EUDAMED. For medical devices, Article 123(3)(ea) MDR provides a period of 18 months, i.e. no later than 27 May 2027; for IVDs, Article 113(3)(fa) IVDR provides a period of 12 months, i.e. no later than 27 November 2026. Failures to comply may have immediate effects on the market availability of entire product lines.
Module 5 – Market Surveillance Without Borders
The fourth functional module concerns market surveillance, governed by Article 100 MDR and Article 95 IVDR. It is the sharpest instrument within EUDAMED, as this is where safety-relevant information converges.
For manufacturers and other economic operators, this entails a new quality of reporting obligations. Safety reports, corrective actions or recalls no longer have merely national effect, but become visible across the Union. National protective spaces effectively cease to exist.
Market surveillance authorities, in turn, receive a coordinated early warning system. Measures taken by one Member State can trigger follow-up reactions throughout the Union. For companies, this increases the risk of cascading enforcement measures if structural deficiencies become visible in this way.
Not Yet at the Finish Line: EUDAMED Between Binding Force and Completion
With the functionality of the first four modules, EUDAMED is not yet complete. The two remaining modules on post-market surveillance/vigilance (Module 4) and on clinical investigations and performance studies (Module 6) have not yet been confirmed, but will further deepen the integration of the pre- and post-market phases.
In order to fulfil the vigilance obligations laid down in Articles 80 et seq. MDR and Articles 76 et seq. IVDR, national reporting channels must continue to be used until the functionality of Module 4 is confirmed (depending on the product, vis-à-vis the BfArM or the PEI). Applications for the authorisation of clinical investigations with medical devices or performance studies (and any notification or reporting obligations existing in this context) pursuant to Articles 70 et seq. MDR and Articles 66 et seq. IVDR must, on a transitional basis, continue to be submitted via the German Medical Devices Information and Database System (DMIDS).
However, these continuing national transitional solutions are explicitly designed not as permanent parallel structures, but as temporary fallback mechanisms.
With regard to EUDAMED Modules 1, 2, 3 and 5, 28 May 2026 serves as a legal fixed point. From this date onwards, evasive moves into national systems or provisional solutions are no longer envisaged. Companies that have so far treated EUDAMED as a project of the future risk falling behind both operationally and legally. The perpetual construction site has become regulatory reality—and that reality rewards preparation just as reliably as it sanctions omissions.
