EC proposes changes to AI in vitro medical device regulation

On 19 November 2025, the European Commission (EC) published a Proposal ¹ for a Regulation to amend the AI Act (AIA) (Digital Omnibus on AI).

This Proposal is intended to simplify the rules and reduce the burden on High-Risk Artificial Intelligence System (HRAIS) providers and deployers, in general. Most AI (In Vitro) Medical Devices ((IV)MD) would be subject to the HRAIS requirements.

On 16 December 2025, the EC published another Proposal ² , to simplify the Medical Devices Regulation (MDR) and the In Vitro Devices Regulation (IVDR) (MDR/IVDR Simplification). This Proposal introduces an amendment to the AIA, that would bring AI (IV)MD out of the scope of the AIA's HRAIS requirements.

As such, there are two Proposals that may impact AI (IV)MD. One proposal is lead by the EC's DG CONNECT, and, one is lead by the EC's DG SANTE.

The Proposals could be adopted as early as the summer of 2026 and as late as the second quarter of 2027.

This article will focus on AI (IV)MD. We provide a general overview of the Digital Omnibus (including data) here and will provide a general overview of the proposed changes to the MDR & IVDR soonest.

A. Most AI (IV)MD would be subject to requirements of both the AIA and the MDR or IVDR

Article 6 of the AIA provides that (IV)MD will be regulated as HRAIS if they fulfil certain conditions. If an (IV)MD:

1) Fulfils the definition of an AIS; and

2) Incorporates an AIS as a safety component or, is the AIS; and

3)  The (IV)MD is above Class I or A according to the MDR or IVDR;

Then, the AI (IV)MD will be subject to the AIA HRAIS requirements.

As a consequence, manufacturers would face the application of the AIA's HRAIS requirements on top of the  MDR/IVDR requirements, from 2 August 2027. This would include the completion of a Conformity Assessment Procedure (CAP) to the AIA.

However, the Proposals introduce a number of changes that would alleviate this burden.

¹ Proposal for a Regulation amending Regulations (EU) 2024/1689 and (EU) 2018/1139 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)
² Proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I

B. The MDR/IVDR Proposal would remove (IV)MD from the default scope of the AIA HRAIS requirements and from the automatic application of a dual Conformity Assessment Procedure

The Proposal to simplify the MDR & IVDR, introduces a change that would move the MDR and IVDR to Section B of Annex I to the AIA. Product safety legislation included in Section B of Annex I instead of Section A, is not subject to the HRAIS requirements. This is unless that, an EC Delegated or Implementing Act explicitly makes specific AIA HRAIS requirements applicable to (IV)MD.

If this part of the Proposal is retained and the EC does not adopt a Delegated or Implementing Act concerning HRAIS (IV)MD, then, the HRAIS requirements would no longer apply to IV(MD).

While the MDR/IVDR Proposal explicitly provides the EC with the possibility to adopt Delegated& Implementing Acts concerning HRAIS (IV)MD, there is currently no such draft Proposal in place.

This Proposal may be great news for AI (IV)MD manufacturers. Regulating (IV)MD as HRAIS may, arguably, have no or limited added value for product safety. This is because the MDR and IVDR do regulate (IV)MD software, including AI. To the extent that any (IV)MD AI specific changes may be necessary, the EC could adopt specific legislation in the future, or, issue relevant and specific guidance.

If this part of the Proposal is adopted, the below Proposal of DG CONNECT, would have limited impact on (IV)MD manufacturers. However, the Council of the EU and the European Parliament (EP), may reject the exclusion of (IV)MD from the scope of HRAIS. In such case, the changes included in the Digital Omnibus Proposal, may still be helpful for manufacturers. In this context, (IV)MD manufacturers may wish to closely follow the adoption process of the two Proposals.

C. The AI Omnibus Proposal would simplify procedures and provide more time to the EC, standardization bodies, NB and to manufacturers

Date of Application: The AI Omnibus Proposal introduces a more flexible date of application (DoA) for HRAIS. If the European Harmonized Standards (EN) are adopted early, the DoA will also apply earlier.

Specifically, the HRAIS DoA would be 12 months after the EC adopts a decision confirming adequate compliance measures are available, or, by 2 August 2028 at the latest

This proposed change provides the standardization bodies and the EC with more time, to develop and adopt the EN, while maintaining some pressure with a cut off date.

NB Designation Process: As seen with the MDR and the IVDR, the designation of NB to a new piece of legislation can take time. Moreover, building up capacity with those NB designated in time, can also take time. The consequence is, that there may be challenging bottlenecks and delays in CAPs. This may in turn, delay the market of entry of both legacy and new devices.

To alleviate the risk of bottlenecks, this Proposal simplifies the NB designation process. Among others, NB should be able to submit a single designation application, to both the AIA and the MDR.

Notified bodies already designated under MDR or IVDR must apply for designation to the AIA within 18 months from the entry into application of the Digital Omnibus on AI.

Single CAP: Further, the Proposal provides that the CAP to the MDR, is to incorporate the assessment of the HRAIS (IV)MD' conformity, to the AIA's HRAIS (Essential) Requirements. In other words, manufacturers would conduct a single CAP with an NB, rather than two CAPs in parallel.

Typology: Finally, the Proposal provides for the introduction of  a new typology system. The proposal introduces a multi-dimensional typology for NB designations, using codes to distinguish between types of AIS, that the NB is qualified to evaluate. This is necessary, because an NB that is designated to the AIA, will not necessarily have been accredited to evaluate every category or type of HRAIS. This approach is similar to the MDR&IVDR.

Clinical Investigations: The scope of Article 60 is expanded to allow real-world testing of HRAIS (IV)MD embedded in products regulated under harmonisation legislation in Section A of Annex I (including, currently, the MDR&IVDR), not just those listed in Annex III.

This should finally close any discussions on conducting clinical investigations with investigational HRAIS (IV)MD. Until now, a conflict of definitions of placing on the market has caused some debates, as to whether clinical investigations with investigational HRAIS MD, are permitted. The EC had previously confirmed that they are, albeit, the related rationale was somewhat vague. The proposed amendment would remove any related uncertainty. Clinical investigations with HRAIS (IV)MD would be subject to the MDR/IVDR rules governing clinical investigations.

D. Next Steps for adoption of the Proposal(s)

The next steps are for the Council of the EU (Council) and the European Parliament (EP) to review the Proposal(s) and negotiate any potential changes thereto. Once that the Council and the EP agree, the Proposal(s) can be adopted. As such, the exclusion of (IV)MD from the scope of the HRAIS requirements, is not yet, a fact.

The Proposals could be adopted as early as Q1 of 2026 and as late as the Q2 of 2027. In principle, the expectation is that the Proposal(s) will be adopted by mid-2026.