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The 2026 MDR revision: What is set to change for clinical investigations – and why the deletion of Art. 82 widens a gap

Why deleting Art. 82 in the MDR is no solution for Europe's scientific community

On 16 December 2025, the European Commission presented a proposal, COM(2025) 1023, for a targeted revision of the MDR (EU) 2017/745 and the IVDR (EU) 2017/746. The stated aim is to simplify procedures, reduce administrative burdens and increase the predictability of certification – without lowering the level of protection for patients. More than three-quarters of the MDR articles are affected in terms of wording or content. For clinical investigations, the changes are manageable – with one exception that is being hotly debated in various committees.

What the Commission is proposing for clinical investigations

Clinical evidence (Art. 2(48), Art. 61, Annex XIV). The definition of clinical data is being expanded: in future, studies published in scientific literature, even if not necessarily peer-reviewed, will also count. The conditions for relying on data from equivalent products are being relaxed, and the contract with the manufacturer of the comparator product is no longer required. For products below the high-risk classes, it will be easier to base the demonstration of safety and performance on non-clinical data, including in-silico methods (New Approach Methodologies).

Obligation to conduct a clinical investigation (Art. 61(4)). The basic rule for implantable class IIb and class III products remains; the exceptions are being reformulated, including via the newly defined category of "well-established technologies" (Art. 2(72)), which replaces the previous product lists.

PMCF (Annex XIV Part B). The results of post-market clinical follow-up are to be incorporated directly into the updated clinical evaluation report; a separate PMCF evaluation report will no longer be required.

Combined studies (new Art. 79a). For studies that combine a clinical trial of a medicinal product under the CTR (EU) 536/2014 with a clinical investigation of a medical device or a performance study of an IVD, a single application should suffice, triggering a coordinated assessment under the CTR. If this route is chosen, the procedural rules of the MDR no longer apply.

Coordination (new Art. 106b). The EMA is to support the competent authorities in multinational clinical investigations – a step towards more uniform application of the coordinated assessment procedure under Art. 78.

Consultation procedure (Art. 54). The Clinical Evaluation Consultation Procedure will be limited to implantable class III products.

In-house manufacturing (Art. 5(5)). Health institutions are to be allowed to share in-house products with other institutions under certain conditions; the Commission explicitly intends this to also promote clinical research into such products.

The deletion of Art. 82 – a regulatory gap widens

The proposal, which is being widely discussed, provides for the deletion of Art. 82 MDR without replacement. No specific justification for this can be found in either the recitals or the Commission's justification table; the deletion likely falls under the general policy of removing "redundant" reference standards (Recital 16). In fact, the number of clinical investigations registered under Art. 82 is low.

Art. 82 governs "other clinical investigations" – studies with medical devices that do not serve the purpose of conformity assessment, but rather answer scientific or care-related questions. This is the typical form of academic, investigator-initiated or care-related research using CE-marked products. Art. 82(1) establishes an EU-wide minimum standard for these studies (protection of the rights, safety and dignity of study participants, scientific validity, ethics committee approval, informed consent); Art. 82(2) obliges Member States to set additional national requirements. Germany has implemented this in § 3 no. 4 and §§ 47 et seq. of the MPDG, including the notification requirement to the BfArM under § 53 MPDG. As a result, the administrative burden for such studies is almost as high as for clinical investigations under Art. 62, making them virtually impossible for scientific institutions to implement, both in terms of personnel and finances.

Removing Article 82 would not simplify matters; instead, it would create a vacuum for three reasons:

Firstly, it would remove the only anchor in Union law for this category of study. What was previously a European minimum standard would be shifted entirely back to national law. For multinational academic studies, this means 27 independent legal regimes – the exact opposite of the intended harmonisation.

Secondly, it remains unclear where these studies would legally belong. One interpretation would assign every clinical investigation not covered by Article 74 to the full procedure under Article 62 – requiring authorisation, a full clinical investigation plan according to Annex XV, sponsor obligations, EUDAMED registration, and vigilance under Article 80. For an observational study involving a CE-marked product used within its intended purpose, this would be a paradoxical tightening of requirements. The other interpretation would remove these studies from the MDR entirely, leaving only professional law, national law, and the Declaration of Helsinki to apply, with no defined sponsor responsibility, no minimum requirements for the investigation plan, and no structured reporting of serious adverse events. Both outcomes are worse than the status quo.

Thirdly, the MPDG would lose its reference standard. Sections 47 et seq. of the MPDG implement and refer to Article 82; without an adjustment to national law, a transition phase would emerge with an unclear legal basis for the very studies that clinics, universities, and research institutes conduct most frequently. The notification requirement to the BfArM – and thus the regulatory visibility of these studies – would no longer be covered by Union law.

Furthermore, there is a technical gap that the proposal fails to address: whether software – such as AI-supported image analysis, remote monitoring, or ePRO systems – is an investigational device or merely an investigational aid in a study remains unanswered. With the deletion, the boundary with Article 62 does not become clearer; it simply disappears.

What needs to be done now

For sponsors and clinical sites, nothing changes until the new rules come into force: other clinical investigations in Germany must continue to be planned in accordance with Sections 47 et seq. of the MPDG, notified to the BfArM, and assessed by the competent ethics committee. In practice, no clinical studies under Article 82 are being conducted in Germany, which is a significant disadvantage for Germany as a research location.

In the legislative process, the Parliament's draft report has not yet addressed Article 82. Academic societies and research institutions have warned of a regulatory gap for investigator-initiated research. The appropriate solution lies not in deletion, but in clarification: a uniform, Union-wide definition of "other clinical investigations" with graduated, risk-based requirements – and a clear distinction for software as an investigational device. As an independent research institute and CRO for medical devices, we will address this point in the further process and work together with others to advocate for a balanced implementation at the relevant decision-making levels.

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(As of September 2026)

Are you interested in whether and how MEDIACC, as a research institute or CRO, can support you with clinical investigations during the medical device approval process? Contactus for an initial consultation!

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