New Medical Device And IVD Registration And Transparency Requirements To Apply In 2026

On 27 November 2025, the European Commission published a notice in the Official Journal confirming that the first four modules of the European database on medical devices (EUDAMED) are fully functional. The notice starts a 6 month transition period at the end of which companies in the medical devices supply chain, as well as Notified Bodies and competent authorities, will need to comply with a range of new obligations regarding registrations and data submission under the Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), as applicable. These include mandatory registration of devices and of economic operators.

What is EUDAMED?

The new EUDAMED is the EU's centralised database for information on medical devices and IVDs on the market in the EU. It is intended to help with implementing strengthened transparency, traceability and post-market surveillance requirements under the MDR and IVDR. EUDAMED comprises several different electronic systems or modules each designed to implement different aspects of these requirements.

Obligations under MDR and IVDR that are reliant on one of the systems within EUDAMED only become applicable following transition periods triggered by the Commission's notice that the relevant system is fully operational.

The development of parts of EUDAMED have been significantly delayed. To help avoid any unnecessary delay in the application of new obligations, each of MDR and IVDR were amended to allow for the gradual roll-out of EUDAMED on a modular basis.

What obligations will come into application?

The Commission's notice indicates that four modules of EUDAMED are now fully operational, meaning the regulatory obligations contingent on those modules will start to apply from 28 May 2026 (or later for certain requirements). These are in summary:

• Device registration and Unique Device Identifier (UDI) database: This module has been available on a voluntary basis for some time but the registrations will become mandatory. From 28 May 2026, all new devices, systems and procedure packs must be registered in EUDAMED prior to the first placing on the market of that new model. For product models where the first sales unit was placed on the market before 28 May 2026, manufacturers will need to register these in the database by 12 months following the Commission's notice. In each case, the UDI data and certain other information will need to be included in the database.

• Registration of economic operators: It will be mandatory for all manufacturers (other than manufacturers of custom-made devices), authorised representatives and importers to be registered in the 'actor' module of EUDAMED prior to the placing on the market of a device. The entity will need to obtain a Single Registration Number (SRN). The SRN will be required where applying to a Notified Body and for accessing certain other aspects of EUDAMED to comply with other obligations. Certain other entities will also need to register in this module in order to perform other obligations for which they must use EUDAMED (e.g. system and procedure pack producers).

• Database on Notified Bodies and Certificates: From 28 May 2026, Notified Bodies must upload all information regarding certificates they issue, including amendments, and regarding suspensions, reinstatements, withdrawals or refusals of certificates and restrictions imposed on certificates. Initially, only information on new certification decisions needs to be uploaded. However, by 28 May 2027, Notified Bodies are required to upload information on certain certificates issued before 28 May 2026 where the product is still placed on the market on or after that date. This database will eventually be generally accessible, so for the first time it will be possible to access information on competitors' certificates in a systematic manner.

• Market-surveillance: Member State competent authorities will be required to carry out certain of their market-surveillance obligations using the relevant EUDAMED module.

What steps should companies take?

Certain elements of the system are already operational and companies may have been complying on a voluntary basis. However, companies will need to ensure that they have submitted all necessary data to the relevant modules of EUDAMED by the deadlines and must allocate appropriate resources. Companies must also ensure that they have systems in place to submit any new information they generate to EUDAMED as required.

In the case of importers and authorised representatives, they will also need to start verifying that the manufacturer of a device has complied with its registration obligations.

Companies must re-confirm the accuracy of certain information submitted to EUDAMED at regular intervals. Companies will therefore need to have systems in place for re-confirmation.

Once the database containing Notified Body certificate information, companies may find the newly available information on competitor certificates useful, for example in the context of disputes.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.