The revision of the EU’s medical device rules is exposing a wider disagreement over how AI should be regulated in healthcare. While industry and some lawmakers argue for less duplication between the Medical Device Regulation and the AI Act, others warn against giving the Commission too much discretion over future requirements.
The dispute came into focus during a debate in the Committee on Public Health (SANT) on a draft report to simplify the rules for medical devices. These are the machines, implants and tests doctors rely on every day. The report’s author, rapporteur Oliver Schenk, wants faster, lighter rules. The sharpest intervention came from socialist MEP Tiemo Wölken. He questioned how much power the proposed approach would give the European Commission to set future AI requirements.
First, the shared diagnosis. Lawmakers across party lines agree that the 2017 Medical Device Regulation (MDR) tightened the rules so much that products disappeared from the market. According to Peter Liese (EPP/DEU) specific heart devices for children are no longer made “because the rules are so complicated and so expensive”. His verdict: “The current MDR is just not fit for purpose.”
It is like a screw. When you turn it, it’s getting tighter and tighter. Until this one moment when you overdo it. — Andreas Glück (Renew/DEU)
German Renew MEP and practising surgeon Andreas Glück put it plainly. “It is like a screw,” he said. “When you turn it, it’s getting tighter and tighter. Until this one moment when you overdo it, then suddenly the screw holds nothing.” And what should have contributed to patient safety turned into the opposite, he added.
The stakes are large. Mr Schenk told colleagues the sector covers 500,000 medical devices and products, thousands of companies, many of which are small and medium-sized enterprises (SMEs), and €170 billion in turnover.
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The question the report leaves open
In his intervention, Mr Schenk himself barely mentioned AI. He raised it only in his closing remarks, listing it among the “debates” still to come, alongside “the principle of equivalence” and “cutting red tape.” That is where the AI question will now play out.
Mr Wölken was clear. The Commission’s plan for AI in medical devices, he said, “it’s just not enough”. His objection: “they’re going to leave everything to an undefined delegated act. And really, I could not agree with that.” He wants the minimum standards for AI in medical devices reviewed.
Two rulebooks for one device
Here is the problem in plain terms. A medical device that runs on AI, software that reads a scan, for instance, now has to satisfy two EU rulebooks at once. One is the MDR, the long-standing safety regime for medical devices. The other is the AI Act, the EU’s 2024 law for “high-risk” AI.
It adds its own checks: testing for bias, keeping a human in control, extra documentation. The two were drafted by different parts of Brussels, and they overlap. Companies end up doing much of the same work twice.
They’re going to leave everything to an undefined delegated act. And really, I could not agree with that. — Tiemo Wölken (S&D/DEU)
The catch is that the two do not check the same things. The device rules were never built to catch AI-specific failures, such as an algorithm that works less well for some groups of patients than others.
Flora Giorgio, head of the Commission’s medical devices unit, said as much: “Human oversight, data integrity, bias, these are all elements which are currently not covered by MDR.”
Industry wants the duplication gone, ideally by following the MDR alone. Patient-safety advocates want the AI Act kept on top, precisely because the device rules do not test for those failures.
In December 2025 the Commission proposed a fix: lift medical devices out of most of the AI Act, then add specific AI requirements back later, one by one, through its own decisions. Those decisions, in EU jargon delegated or implementing acts, largely bypass the Parliament.
That is the blank cheque Mr Wölken is worried about. The Commission would decide later, with little public debate, what AI safety rules medical devices must actually follow.
Where things stand
EU governments rejected the exemption. On 7 May 2026, Parliament and member states agreed the Digital Omnibus reform of the AI Act. Machinery won a clean exemption. Medical devices did not. They stay under both rulebooks. The deadline for high-risk AI built into products, medical devices included, was pushed back to 2 August 2028.
The Commission does not undermine the AI Act. It is simply making the AI Act requirement more fit for purpose and targeted to medical devices. — Flora Giorgio, European Commission
But a softer version of the “Commission decides later” mechanism survived. The Commission can still switch off parts of the AI Act for medical devices where it judges the MDR already covers the same ground.
Not the only view
Others see it differently. András Kulja (EPP/HUN) defended the compromise. He said it “empowers the Commission through implementing acts to limit the application of certain AI requirements” where the MDR and also the In Vitro Diagnostic Medical Devices Regulation (IVDR) already provide an equivalent level of protection, warning against unnecessary duplication.
The Commission rejects the idea that it is weakening anything. “It does not undermine the AI Act,” Ms Giorgio told the committee. It is “simply making the AI Act requirement more fit for purpose and targeted” to medical devices, she said.
Industry and watchdogs weigh in
The debate extends well beyond the committee room. On 9 July 2026, the TIC Council, which represents testing and certification bodies, urged lawmakers to “keep AI-based medical devices within the AI Act”. Industry pulls the other way.
MedTech Europe, the sector’s trade body, called parallel compliance “not the outcome we sought”. It now sees the device revision as “the critical vehicle” to fix what the omnibus did not. DIGITALEUROPE, another industry group, described the outcome a “missed opportunity” that leaves medtech firms, 95 per cent of them small companies, facing “overlapping obligations”.
The deadline to table amendments is 20 July 2026. The committee is expected to vote in early December 2026, with a first Parliament position around mid-December, before talks with member states in spring 2027.
