Updates in medical device law – The EU takes action (?)

The regulatory landscape for medical devices is constantly changing on an international level. For all stakeholders, these changes make it necessary to stay informed permanently about new developments and adapting internal processes in a timely manner. This brief “update on the news in medical device law” summarizes some important developments at EU level.

Several EUDAMED systems have been operational since November 27, 2025

Article 33 of the Medical Device Regulation (EU) 2017/745 (“MDR”) regulates the establishment of the European Database on Medical Devices (EUDAMED). The following systems are integrated into EUDAMED:

(a) Registration of products
(b) UDI database
(c) Registration of economic operators
(d) Notified bodies and certificates of conformity
(e) Clinical investigations
(f) Vigilance and post-market surveillance
(g) Market surveillance

The individual provisions of the MDR (e.g., Articles 29 and 31 MDR) specify who must store which data in EUDAMED.

Individual EUDAMED systems were already available, but they were not yet officially “fully functional.” Registration requirements were therefore not binding until now.

The update

On November 27, 2025, the EU Commission published a decision ((EU) 2025/2371) according to which the systems (a) – (d) and (g) are functional. In doing so, the Commission combines the systems for registering products (a) and the UDI database (b) into one system. Economic operators have until May 27, 2026, to comply with their registration obligations (Art. 123(3) (d) MDR).

The verification obligations of distributors under Art. 14 MDR before the ECJ (C 10/24)

At the end of 2023, the Federal Court of Justice (Bundesgerichtshof - BGH) had to rule on the scope of distributor obligations under Art. 14 MDR. The BGH had doubts about the interpretation of the European regulation and inter alia referred the following questions to the European Court of Justice (ECJ) for a preliminary ruling:

1. Must a distributor verify the existence of a medical device or accessory (and therefore also with regard to the CE marking and the existence of a corresponding MDR declaration of conformity) if the manufacturer has not assessed it as such?
2. Is it relevant to question 1. whether the product has been CE marked by the manufacturer at all, as a medical device/accessory or as another product?
3. Must a distributor check the classification of the product being sold as class IIa and the resulting conformity requirements (e.g., identification number of the notified body)?

The opinion of the Advocate General responsible, which has now been published, provides initial indications as to how the ECJ's decision might ultimately turn out.

The Advocate General essentially argues that distributors should at least not be required to carry out an in-depth examination of the classification of a product as a medical device within the meaning of the MDR. In summary, the Advocate General stated as follows:

• With regard to questions 1 and 2, distributors should have to check, on the basis of the product information available to them, whether the CE marking and the EU declaration of conformity “clearly” refer to a medical device. Distributors should therefore carry out a “plausibility check” on the manufacturer's product classification in accordance with their duty of care.

• In addition, the Advocate General clarified with regard to the third question that distributors should not generally be required to check the correct classification of a product. However, if it were apparent from the product information that the conformity assessment procedure required the involvement of a notified body, the distributor should have to check that the identification number of the notified body was correct.

It is still uncertain whether the ECJ will endorse these views. For reasons of legal clarity, it would at least be desirable for the ECJ to specify the requirements for the “obviousness” of the existence of a medical device.

EU reform efforts within the framework of the Digital Omnibus

On November 19, 2025, the EU Commission announced its proposals for simplifying digital regulation (known as the Digital Omnibus). These also include suggestions for revising the transition periods for high-risk AI systems, which generally include medical AI.

The Commission has advocated linking the entry into force of the regulations on such high-risk AI systems flexibly to different variables, such as the availability of “support measures” (these include, for example, harmonized standards, common specifications, and Commission guidelines).

At the same time, the reform proposal provides for the inclusion of so-called backstop deadlines. In any case, the regulations on high-risk AI systems in accordance with Annex I (and thus also medical devices with AI) should be binding by August 2, 2028, at the latest.

Overall, the proposed complex deadline mechanism leads to planning difficulties for the affected industry. If the EU Commission's proposal is implemented into law, the only definitive deadline would be August 2, 2028. Whether this implementation will actually take place is still unclear.

The full reform proposal of the EU Commission on the AI Regulation is available here.

Draft implementing regulation on the obligations of notified bodies under Annex VII MDR

Annex VII of the MDR sets out the legal requirements that notified bodies must meet and how cooperation between them and medical device manufacturers should work within the framework of conformity assessment procedures. However, many manufacturers consider these regulations to be insufficient. They argue that they do not provide a reliable and adequate legal basis for the cooperation between them and the respective notified body, which is further specified in private contracts. The industry criticizes in particular the lack of transparency regarding costs and schedules that are difficult to calculate. Costs and duration also hinder competitiveness (at least in part).

With its draft regulation concerning Annex VII of the MDR, the European Commission is responding to these calls and pursuing the goal of creating more uniformity and predictability with and between notified bodies. The recently published document (draft) inter alia provides for the following binding deadlines,:

• Review of manufacturer applications and contract signing (30 days),
• Auditing of QM systems (120 days),
• Product verifications, in particular the review of technical documentation (90 days)
• Final decision on the issuance of certificates after the final review of the documents (15 days).

The draft also provides for structured rules regarding the interruption of these deadlines (so-called clock-stop mechanisms). The publication also contains proposals for the minimum content of cost estimates and monitoring obligations of notified bodies regarding the duration and costs of conformity assessments. In the future, recertification is also to be more targeted and without a de facto “reassessment.”

The draft is a step in the right direction. However, these regulatory proposals are not yet final and binding. It therefore remains unclear whether the draft will actually be adopted in its current form.

The complete draft is available here.