Back in November 2025, the Commission tabled a proposal for a digital omnibus regulation on AI, which aims to relax the requirements set out in Regulation (EU) 2024/1689 (hereinafter: Artificial Intelligence Act, or AIA for short) in terms of timing. For AI systems already covered by the EU’s sectoral legislation on safety and market surveillance, it is proposed to postpone the deadline for application from 2 August 2026 to 2 August 2028. The European Parliament recently approved this postponement by a large majority on 26 March 2026. In parallel with these efforts, on 16 December 2025 the Commission published a proposal for a regulation amending the MDR/IVDR, which, among other things, is intended to largely exempt AI-based medical devices from the application of the AIA requirements. Understandably, these legislative developments are raising a fundamental question within the medtech industry: whether, and to what extent, the AIA will continue to play a regulatory role in the long term in the development and use of AI-based medical devices.
This article addresses this question. To this end, it first provides an overview of the current regulatory status of AI-based medical devices (see Section I). It then examines in more detail the Commission’s draft amending regulation to the MDR/IVDR concerning the regulation of AI-based medical devices (see Section II). The need for action by the relevant stakeholders is then discussed on the basis of a scenario analysis (see Section III). The article concludes with a summary and an outlook (see Section V).
I. Regulation of AI-based medical devices – current situation
1. Parallel application of the MDR/IVDR and the AIA
Since its entry into force on 2 August 2024, the AIA has formed the central regulatory framework containing AI-specific requirements to regulate the use of AI in a horizontal and risk-based manner. From its (current) date of application on 2 August 2026, affected medical device manufacturers must comply with the requirements of the MDR and the AIA as soon as a medical device in the form of software (Art. 2(1) MDR) also constitutes an AI system within the meaning of Art. 2(1) AIA. The AIA is to be understood as a horizontal supplement to the (sectoral) safety and performance requirements standardised in the MDR, specifically for AI-based medical devices (software).
Article 6 of the AIA sets out, by means of two cumulative conditions that must be met, whether or not an AI system is to be classified as a high-risk AI system. The first cumulative condition: AI systems are considered high-risk under Article 6(1)(a) in conjunction with Annex I, Section A of the AI Act if, as a product or as a safety component embedded in that product, they fall within the scope of the legislative acts listed in Annex I. Under the current regulatory framework, the MDR/IVDR is also included among the listed legislative acts. The second cumulative requirement: The AI system itself, as a product, must undergo a third-party conformity assessment with a view to the placing on the market or putting into service of that product in accordance with the legal acts listed in Annex I of the IIA (Article 6(1)(b) of the IIA). As medical device software must generally undergo a third-party conformity assessment (see current Rule 11 of the MDR), AI-based medical devices fulfil the cumulative requirements set out in Article 6(1) of the AIA and are regularly classified as high-risk AI systems.
The consequence of this risk classification is that such medical devices must meet the substantive requirements of the AIA, which are set out in Article 8 et seq. of the AIA. These substantive requirements include, in particular, the establishment of a risk management system (Article 9 of the AIA), data and data governance (Article 10 of the AIA), the assurance of human oversight (Article 14 of the AIA), and compliance with accuracy, robustness and cybersecurity (Article 15 of the AIA). However, pursuant to Article 113(c) of the AIA, the central classification provision under Article 6(1) of the AIA and the resulting obligations (including compliance with the aforementioned substantive requirements under Article 8 et seq. of the AIA) shall only apply from 2 August 2027.
2. Substantive overlaps and divergences
As the MDR/IVDR already constitutes a highly regulated field in its own right, the parallel application of the AIA naturally gives rise to many overlaps in content. This applies in particular to overlaps with the substantive safety and performance requirements set out in Annex I of the MDR/IVDR. In view of this, it is not surprising that a detailed analysis of both sets of regulations reveals some substantive and conceptual divergences and inconsistencies. This stems in particular from the fact that sector-specific features, which are set out in the MDR, are not sufficiently taken into account in the horizontally structured AIA.
II. Planned amendments under the Commission’s draft
Due to the aforementioned overlaps and divergences in content, the Commission decided on 16 December 2025 to submit a proposal as part of the Commission draft amending the MDR/IVDR (COM (2025) 1023 final), to submit a proposal aimed at resolving the complex and, in some respects, contradictory regulatory framework in favour of a purely sector-specific regulation of AI-based medical devices.
1. Transfer of the MDR/IVDR to Annex I, Section B of the AIA
To this end, Article 4 of the Commission’s draft provides that the MDR and the IVDR are to be removed from Annex I, Section A of the AIA and instead added to Section B of the AIA. With this amendment, Article 2(2) of the AIA would be applicable in future. Accordingly, for AI systems classified as high-risk AI systems in accordance with Article 6(1) of the AIA and which are related to products covered by the legislative acts listed in Annex I, Section B, only
- Article 6(1) of the AIA (concerning the classification provision for high-risk AI systems),
- Articles 102 to 109 of the AIA (concerning the amendment of regulations by the AIA)
- and Article 112 of the AIA (concerning the evaluation and review of the list in Annex III and the list of prohibited practices in the field of AI).
Consequently, the regulatory implication of Article 2(2) of the AIA would be that AI-based medical devices, despite being classified as high-risk AI systems under Article 6(1) of the AIA, would no longer be required to meet the substantive requirements set out in Article 8 et seq. of the AIA (Chapter III, Section 2). Through this technical manoeuvre, the Commission aims to ensure that the matter can in future be regulated exclusively through the MDR/IVDR.
2. Implementing and delegated powers
The Commission also confirms this in Recital 23, paragraphs 2 and 3, of its draft. It correctly notes that the parallel application of the MDR or IVDR and the AIA could lead to overlapping requirements and thereby hinder innovation. To avoid such overlaps and simplify the legal framework for AI-based medical devices, the application of the AIA to these products is to be limited to the provisions set out in Article 2(2) of the AIA. Where necessary, the Commission may make use of its implementing and delegated powers to lay down specific requirements relating to artificial intelligence, taking into account the requirements set out in Chapter III, Section 2 of the AIA (Recital 23, p. 5 of the draft). This requirement is also reflected as a provision to be incorporated into the MDR. Pursuant to Article 1(5)(b)(8) of the Commission’s draft, which aims to recast Article 5(8) 8 MDR, the Commission is to take into account the requirements set out in Chapter III, Section 2 of the aforementioned Regulation when adopting implementing acts, delegated acts or common specifications relating to devices that use high-risk AI systems within the meaning of Article 6(1) of the AIA or high-risk AI systems as safety components.
The solution proposed by the Commission could, in future, lead to an overall simplification of the complex regulatory framework whilst enabling the introduction of requirements tailored to the specific characteristics of the development and use of AI-based medical devices. At the same time, it must not be overlooked that Recital 23, paragraph 5 of the draft seeks to permit the addition of AI-specific requirements in the form of implementing and delegated powers only to the extent that this is ‘necessary’.
III. Need for action by affected stakeholders?
Against the backdrop of this Commission proposal, the question is currently and quite rightly being raised within the medtech sector as to what action is required of affected stakeholders such as medical device manufacturers – in particular, whether the requirements of the AIA should be taken into account and preparations made for compliance.
When answering this question, the starting point is always the applicable law: under current legislation, the MDR/IVDR and AIA apply in parallel. The requirements for high-risk AI systems will apply from 2 August 2026 and 2 August 2027 respectively. This means that medical device manufacturers are already required to ensure that their AI-based products can meet the requirements by 2 August 2027 at the latest. It should also be noted that the Commission’s proposal is currently still undergoing the legislative process. As things stand, it is therefore not certain whether the Commission’s draft will be adopted in this form, and if so, whether the Commission will, in a second step, exercise its discretion at all and issue specific requirements for AI-based medical devices by means of delegated acts.
1. Possible scenarios
Against this background, the following scenarios arise, which affected stakeholders should currently take into account in their legal and operational decisions:
Scenario 1: The Commission’s draft fails completely in the legislative process, meaning that the current law remains in force unchanged. Affected medical device manufacturers would therefore be obliged to comply with the requirements of the AIA in addition to those of the MDR and IVDR by 2 August 2027 at the latest. Even if the proposal for a digital omnibus regulation on AI were to succeed in the legislative process and thus delay the entry into force of the AIA, those affected would ultimately still have to comply with the requirements of the AIA.
Scenario 2: Article 4 of the Commission’s draft successfully passes through the legislative process and is implemented without amendments. In this scenario, affected medical device manufacturers would be exempt from the obligation to comply with both the requirements of the MDR and IVDR and those of the AIA. Instead, in this scenario, AI-based medical devices would be developed and placed on the market exclusively in accordance with the provisions of the MDR and IVDR. In this scenario, the Commission continues to conclude that there is no need for further clarification in the form of implementing or delegated acts. Uncertainties regarding AI-specific issues would thus resurface, which were the initial trigger for the implementation of medical devices under the AIA.
Scenario 3: Article 4 of the Commission’s draft successfully passes through the legislative process and is implemented without amendments. In this scenario, the Commission continues to conclude that there is a need for further clarification in the form of implementing or delegated acts. Sub-scenarios arise here regarding the content of the implementing or delegated acts:
- Sub-scenario 1: Specific AI requirements are very closely aligned with the AIA.
- Sub-scenario 2: Specific AI requirements are based on Chapter III, Section 2 of the AIA, but take appropriate account of the specific features of medical device law.
2. Scenario analysis
Whether and to what extent action is required by affected medical device manufacturers ultimately depends heavily on how the legislative process regarding the MDR reform unfolds.
Scenario 1
What is certain, in any case, is that gap analyses in the past have shown that the MDR/IVDR does indeed contain regulatory gaps regarding the use of AI technology; however, these should be addressed in a manner that is aligned with existing sector-specific regulations. Not least for this reason, the horizontally chosen ‘ ’ regulatory approach met with widespread opposition from the medtech industry as early as the legislative process for the AIA (see Schreitmüller, ‘Regulation of Intelligent Medical Devices’, for details). With the Commission’s current initiative, the concerns of the medtech industry raised during the legislative process for the AIA appear to have finally been heard, which is why Scenario 1 can be tentatively ruled out with cautious optimism. This is also supported by the Commission’s parallel efforts to delay the entry into force of the AIA through the proposal for a Digital Omnibus Regulation.
Scenario 2
This leaves scenarios 2 and 3 for the medical device manufacturers concerned. Taking into account the wording in Recital 23 of the Commission’s draft (“…where necessary…”), one might be inclined to think that the Commission assumes the MDR and IVDR are, in principle, suitable for adequately addressing AI-specific issues. However, Scenario 2 seems rather unlikely, given that the MDR/IVDR would not have been incorporated into the AIA had the Union legislator not identified any regulatory gaps from the outset.
Scenario 3
For these reasons, Scenario 3 appears the most likely. However, AI-specific requirements that are very closely aligned with the provisions of the AIA are very unlikely to be developed, given the complex legislative process required to provide an appropriate sectoral regulatory approach. Otherwise, the existing regulation could have been left in the AIA; a particular criticism in this context is that sector-specific characteristics are not sufficiently taken into account in the AIA, such as the requirements for human oversight, which are entirely alien to medical device law. A direct transposition of the AIA requirements into the MDR therefore seems highly implausible.
Rather, AI-specific requirements that take sufficient and appropriate account of the specific features of medical device law are desirable and, in all likelihood, also the Commission’s long-term objective. These are expected to be drafted in such a way that they incorporate the substantive requirements underlying the AIA, at least as cornerstones for the delegated act. Affected medical device manufacturers should therefore already familiarise themselves sufficiently with the aspects of transparency, risk assessment, traceability, human oversight and data governance.
However, it would be short-sighted to assume that AI-based medical devices will be deregulated as a result. Rather, the aim – quite rightly – is to regulate AI-based medical devices consistently and in a manner tailored to sector-specific characteristics. Even if a reduction in the substantive requirements does not appear likely at this stage, there should nevertheless remain hope that, despite numerous requirements, the nature and content of the requirements will be easier to implement, as they will be better drafted and more harmonised from a legislative perspective.
Conclusion and outlook
Taken as a whole, adopting a wait-and-see approach and hoping that the Commission’s proposal will be implemented into law as intended is not entirely naive; however, this initiative should not be interpreted as a measure aimed at deregulation. , AI-based medical devices will in future most likely no longer be regulated in parallel by the MDR, IVDR and AIA, but will instead be regulated at a purely sectoral level in a more granular manner than has been the case to date.
It remains to be seen, therefore, whether the AI-specific guidelines to be developed in the future will be convincing in terms of content and quality, and whether they can lead to greater legal certainty and, ultimately, to a noticeable reduction in the regulatory burden for the medical device manufacturers concerned.
Do you have any questions about this news, or would you like to discuss it with the author? Please contact: Dr. Zeynep Schreitmüller
