Updates on the Medical Device Regulation – The EU Takes Action (?)

At the international level, the regulatory landscape for medical devices is constantly changing. For all stakeholders, this means staying informed about new developments and adapting internal processes in a timely manner. With this brief “Update on the Medical Device Regulation,” we would like to summarize some important developments at the EU level.

Several EUDAMED systems have been operational since November 27, 2025 

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

(a) Product registration

(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 specific regulations of the MDR (e.g., Articles 29 and 31 of the MDR) determine who is required to submit which data to EUDAMED.

Although individual EUDAMED systems were already available, they were not yet officially “fully operational.” Consequently, the registration requirements were not yet binding.

And here is the update:

On November 27, 2025, the European Commission published a decision ((EU) 2025/2371) confirming that systems (a) through (d) and (g) are operational. In doing so, the commission “combines” the product registration systems (a) and the UDI database (b) into a single system. Economic operators have until May 27, 2026, to comply with their registration obligations (Art. 123(3)(d) MDR).

Distributors’ verification obligations under Art. 14 MDR before the ECJ (C 10/24)

At the end of 2023, the Federal Court of Justice (BGH) had to rule on the scope of distributors’ obligations under Art. 14 MDR. The BGH had doubts regarding the interpretation of the European regulation and referred the following questions, among others, to the European Court of Justice (ECJ) for a preliminary ruling:

1. Is a distributor required to verify whether a product is a medical device or accessory (and thus also to assess whether it bears the CE marking and is accompanied by a corresponding MDR declaration of conformity) if the manufacturer has not classified it as such?

2. Is it relevant to the first question whether the manufacturer has affixed a CE mark to the product at all, or whether it has done so as a medical device/accessory or as another type of product?

3. Must a distributor verify the classification of the product being sold as Class IIa and the resulting conformity requirements (e.g., the identification number of the Notified Body)?

The recently published Opinion of the Advocate General provides initial, tentative indications as to how the ECJ’s decision might ultimately turn out.

The Advocate General essentially argues that distributors are not required to conduct an in-depth examination of a product’s classification as a medical device within the meaning of the MDR. In summary, the Advocate General stated the following:

• With regard to questions 1 and 2, distributors would have to assess, based on the product information available to them, whether the CE marking and the EU Declaration of Conformity “clearly” refer to a medical device. Accordingly, distributors would be required, as part of their duty of care, to conduct a sort of “plausibility check” on the manufacturer’s classification of the product.
• Furthermore, regarding the third question, the Advocate General clarified that distributors are generally not required to verify the proper classification of the product. However, if it is apparent from the product information that the conformity assessment procedure requires the involvement of a Notified Body, the distributor must, in principle, verify that the identification number of the Notified Body is correctly stated.

It remains to be seen whether the ECJ will concur with these views. For the sake of legal clarity, it would at least be desirable for the ECJ to specify the requirements regarding the “obviousness” of a product’s classification as a medical device.

EU reform efforts under the Digital Omnibus

On November 19, 2025, the European Commission announced its proposals to streamline digital regulation (known as the Digital Omnibus). These proposals also include suggestions for revising the transition periods regarding 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 various variables, such as the availability of “support measures” (including, 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 under Annex I (and thus also on medical devices incorporating AI) should become binding by August 2, 2028, at the latest.

Overall, the proposed, complex deadline mechanism leads to planning difficulties for the affected industry. Should the European Commission’s proposal be enacted into law, the only definitive deadline would be August 2, 2028. Whether this implementation will actually take place remains to be seen. The European Commission’s full reform proposal for the AI Regulation is available here.

Update as of May 11, 2026

On May 7, 2026, the European Commission, the Council, and the European Parliament reached an agreement on a reform of the AI Regulation. In its press release, the European Commission inter alia announced a new timeline for the transition periods: regulations for systems used in certain high-risk sectors (e.g., critical infrastructure and education) are to take effect on December 2, 2027. Regulations for systems integrated into products (e.g., medical devices) are however not set to take effect until August 2, 2028. The agreement confirms the implementation timeline already proposed by the European Commission last year. The EU has thus now clarified its common goal—however, the formal and legally binding implementation of the aforementioned transition periods is still pending.

Supplement: Draft Implementing Regulation on the Obligations of Notified Bodies under Annex VII of the MDR

The requirements that Notified Bodies must meet and the procedures for cooperation between them and medical device manufacturers in the context of conformity assessment procedures are set forth (at least in outline) in Annex VII of the MDR. However, many manufacturers consider these regulations to be insufficient. They argue that these regulations do not provide a reliable and adequate legal basis for the cooperation between them and the respective Notified Body, which is further defined in private contracts. The industry primarily criticizes the lack of transparency regarding costs as well as schedules that are difficult to calculate. Costs and duration also hinder competitiveness (at least in part).

With the draft regulation to clarify Annex VII of the MDR, the European Commission is responding to these calls and aims to create greater uniformity and predictability with and among Notified Bodies. The recently published document (draft) provides, among other things, for the following binding deadlines:

• Review of manufacturer applications and contract signing (30 days),
• Audit of quality management systems (120 days),
• Product verification, in particular review of technical documentation (90 days),
• Final decision on certificate issuance following the final review of documents (15 days).

The draft also provides for structured rules regarding the suspension of these deadlines (so-called “clock-stop” mechanisms). Furthermore, the publication includes proposals for minimum content requirements for cost estimates, as well as monitoring obligations for Notified Bodies regarding the duration and costs of conformity assessments. Recertification is also intended to be more targeted in the future and to take place without a de facto “reassessment.”

The draft is a step in the right direction. However, these regulatory proposals are not yet final or binding. It therefore remains to be seen whether the draft will actually be adopted in this form. The full draft is available here.