The EU Commission has been busy – MDR Proposal and EUDAMED
In the run-up to Christmas, a lot happened- alongside holiday shopping, baking cookies and the end-of-year rush, the EU Commission advanced concrete requirements and potential innovations in two key areas. The most immediate development is Commission Decision (EU) 2025/2371, which declares four EUDAMED modules functional. As a result, their mandatory use will start on 28 May 2026.
Furthermore, the EU Commission has proposed extensive amendments to the MDR and IVDR aimed at reducing the burden on manufacturers. What these amendments would look like in practice – and whether they are likely to be adopted – is covered in this article.
Functionality of four EUDAMED modules
As anticipated for some time, the EU Commission has, with a four-month delay, formally declared important modules of the EUDAMED database to be operational.
This results in the following deadlines for the respective modules:
- Actor registration – registration as an economic operator – valid from 28 May 2026
- UDI/ Devices registration
- Product registration for all MDR products – valid from 28 May 2026
- For devices that still fall under the MDD transitional provisions and will continue to be placed on the market under the MDD after 28 May 2026, a transition period of 12 months applies, until 28 November 2026
- Notified Bodies and Certificates – valid from 28 May 2026
- Market Surveillance – valid from 28 May 2026
Access to the modules is provided via the EUDAMED landing page, where the latest updates are also published. Publicly available information can be retrieved directly through the database.
Over the course of the year, the vigilance module is also expected to be declared functional – according to the current timeline, this is planned for Q4 2026. If this timeline is met, mandatory use would start six months later, i.e. in Q2 2027.
Key updates and guidance are available in the EU Information Centre on the EUDAMED database. If these resources are not sufficient, we will be pleased to support you in preparing your datasets to ensure timely reporting in line with the deadlines.
The EU Commission’s MDR proposal
On 16 December 2025, the EU Commission presented a proposal to simplify Regulation MDR (EU) 2017/745 and IVDR (EU) 2017/746. The proposal includes extensive amendments and – hopefully – simplifications for manufacturers of medical devices and in vitro diagnostic medical devices.
The most significant /far-reaching proposed changes relate to the following areas:
- Article 10 General obligations of manufacturers
- Article 17 Single-use devices and reprocessing of devices that are not for single use
- Articles 27-31 UDI and EUDAMED-related articles
- Chapter VI Clinical evaluation and clinical investigations
- Annex VII Requirements to be fulfilled by notified bodies
- Annex VIII Classification
- Annex IX / X / XI Conformity assessment procedures
Particularly noteworthy are ideas and proposals such as the
- Regulatory Sandbox, a controlled environment established by a competent authority that enables manufacturers or potential manufacturers to develop, test, validate and, where appropriate, use an innovative product or technology that may fall within the scope of the MDR under a plan for a limited period of time under regulatory supervision;
- Well-established technology devices, products that belong to a generic product group that has already been on the market for a long time with a consistent design and has not posed any known safety risks in the past. These WET devices could also have an impact on the classification, reporting requirements and conformity assessment procedures for certain product categories.
- Technical documentation is the responsibility of the supplier: If manufacturers have products designed and manufactured by third parties, e.g. their suppliers, the manufacturer should be able to ensure that relevant parts of the technical documentation are prepared and kept by the supplier rather than by the manufacturer, and up to , and only providing them to the competent authorities upon request. Further chapters in accordance with Annex II, in particular the information to be provided by the manufacturer, must be created by the manufacturer and kept up to date.
- Structured dialogue: Introduction of a formal definition for structured dialogue between manufacturers and notified bodies prior to the conclusion of a contract and before, during and after submission of the documentation. So far, this has only been addressed in MDCG Guidance Documents 2022-14 and MDCG 2019-6. Incorporating it into the MDR could create additional opportunities to clarify misunderstandings.
- Elimination of certificate validity: the current maximum validity period of certificates will no longer be limited to 5 years. Furthermore, a periodic, risk-based review by the notified bodies is planned to ensure the validity of the certificate. In principle, a simplification of the conformity assessment procedures is planned.
- Cybersecurity is addressed as a clear requirement by means of a new standalone article and by clear inclusion in the General Safety and Performance Requirements.
Initial Reactions from the Medical Technology Industry
Overall, the proposals were received positively. In an initial statement, MedTech Europe welcomed the proposal, but concluded that the adjustments did not yet go far enough. BVMed also responded positively to many of the proposals, but immediately listed further areas for improvement. Taken together, the overall sentiment can be described as broadly positive. To date, more extensive statements from patient representative organisations have not yet been published.
What happens next and how likely is it that the proposals will be accepted?
First, this is a proposal by the EU Commission. It must be agreed with the Council of the EU and the European Parliament as part of the ordinary legislative procedure, including potential trilogue negotiations. At present, the Commission has opened a feedback period for comments from economic operators until 19 March 2026.
Medical devices and in vitro diagnostics – targeted revision of EU rules
Looking back at the original legislative process for the MDR and IVDR, one can only hope that the amendments will be adopted more quickly – the original process took over five years.
Whether the proposed changes will ultimately be implemented in exactly this form remains entirely open, particularly as the EU Parliament typically places a stronger emphasis on patient safety and may therefore reject some of the proposed simplification.
Are you not yet sufficiently prepared for the MDR/IVDR? Would you like to enter into dialogue with your notified body now, but are unsure how to proceed? We are pleased to support you with all matters relating to the implementation of the MDR and IVDR, regardless of which revision of the regulations is being discussed. Please feel free to contact us.
