Medical Device Regulation 2.0: Why stakeholder disagreement is bad for all

I have rarely, if ever, seen such a lack of consensus among stakeholders in the EU medical devices community as appears to exist at the moment. The proposals for Medical Device Regulation (MDR) 2.0, published in December 2025, aim to reduce and simplify rules on medical and in vitro diagnostic devices, but instead have exposed a thinly concealed divergence of opinions which will have serious downstream consequences if not resolved.

The importance of stakeholder consensus in regulatory reform

‘Consent of the governed’ has underpinned UK democratic political thinking since the writing of Thomas Locke in the mid-seventeenth century. It also extends to kings, queens and dictators who are perceived to have overstepped their mandate, causing them to be overthrown or forced into compromise, as seen with the Magna Carta of 1215 AD where the rights of citizens were codified in England, constraining royalty for centuries to come. As is seen throughout history, the contract between governors and those who are governed is delicate and becomes strained when parties think that the position of others is starkly at odds with their own interests.

This principle extends to all aspects of the law, including regulation which is designed to create the best outcomes for the population as a whole, but which needs to balance the concerns and constraints that apply to different stakeholders. Good outcomes are where there is broad consensus on the balance, accepting that no party gets everything that they want but all can live with the final position. Failure to achieve this outcome leads to recriminations and blame games when the regulatory system is challenged. This generally happens at a time when all stakeholders should be coming together to resolve the issue in a collaborative manner and learning from the experience.

The UK has been the home of many helpful reviews and guidance relating to good regulatory practice. These date back to the Hampton Report (‘Reducing administrative burdens: effective inspection and enforcement’) in 2005, the Macrory Review (‘Regulatory Justice: Making Sanctions Effective’) in 2006 and The Regulators’ Code (published by the Department for Business, Innovation and Skills) in 2014. All of these emphasise the importance of stakeholder engagement, built trust and the open exchange of information. Professor Christopher Hodges builds on these principles in his 2026 book ‘Regulation that Works’, where he stresses that shared ownership of the regulatory system ‘powerfully supports compliance and innovation in performance’.

Laws and regulations that are perceived to be unfair to any group of stakeholders are difficult to uphold, with people then feeling justified in breaking or bending the rules. Or, in the case of MDR 2.0, when the next product failure challenges the system, the European Parliament, the European Commission, Member States, notified bodies, industry and patient representatives will sharpen their teeth and engage in a lengthy round of internecine conflict, rather than pooling learning, fixing the problem and evolving both legislation and processes to ensure that the system is strengthened rather than reputationally damaged.

Lessons from the transition from MDD to MDR

It is true to say that events drive legislation for better or worse, and that good regulation is designed in a cool, considered environment away from crisis management situations. These contradictory statements are at the core of why the EU medical devices legislation is where it is today. Looking to past examples, the PIP breast implant scandal interrupted a sensible and timely legislative revision process which started as ‘the Recast of the Medical Device Directives’ in the early part of 2008. Sensible stakeholder engagement and methodical development of improved legislation was hijacked, and the end result, helped by major concerns about metal-on-metal hip implants, was a knee-jerk response to events which produced the Medical Device Regulation 2017/45. This legislation was an over-compensation for events that had hit the headlines, resulting in an excessively prescriptive and bureaucratic package which did little to enhance outcomes for patients. The focus on clinical evidence was entirely appropriate, but much could have been achieved by the effective implementation of MedDev 2.7.1 Rev 4. The many inconsistent interpretations of the Medical Device Directive (MDD) were highlighted in the MDR discussions, but it is not clear whether these have been resolved in the extensive tracts of either the MDR or MDR 2.0.

Arguably, the primary failure of the MDD was one of implementation, and there is a very real danger that this will be repeated with MDR and MDR 2.0. The inconsistent performance of notified bodies remains a major frustration within the system and requires more integrated management. The joint audit programme introduced in 2014 under the MDD was a good start but clearly didn’t resolve the problem. I would now advocate enhanced and centralised capacity for the supervision of notified bodies, acknowledging the legislative challenge that this brings under the New Legislative Framework (NLF). It is not clear that the proposals in MDR 2.0 do anything to improve the consistency of performance and may, in fact, drive increased divergence of interpretation.

Addressing structural weaknesses in the EU medical device system

At the core of the implementation challenges for both MDD and MDR is a combination of a lack of resources dedicated to coordinating and running the system, and a fundamental flaw in the architecture of the EU. The European Commission, Parliament and Member States share responsibility for the running of the system and, as a consequence, there is no clear leadership or accountability. In the pharmaceutical sector, there is capacity and capability under the leadership of the European Medicines Agency. This, via its Management Board, provides the badly needed ‘glue’ to hold the disparate Member State interests together and act as a source of expertise. Such ‘glue’ is entirely absent for medical devices. The technological and risk management challenges for medical devices are arguably as complex and demanding as for medicines, but the capacity, capability and leadership for devices from within the system are nowhere near comparable.

MDR 2.0 is potentially another inevitable knee-jerk reaction to the excesses of MDR. Prior to MDR, Europe was the favoured launch pad for many innovative technologies, with the US being seen as an expensive, slow and uncertain environment despite the size of its market. Under enlightened leadership at the US Food and Drug Administration, this situation was reversed over a ten-year period. This was achieved without recourse to significant legislative change, but instead by using available levers in a pragmatic way. MDR 2.0 gives the impression of trying to achieve a reversal of what took ten years in the US, but in just six months, and it does little to address the implementation deficiencies that characterised previous cycles of legislative change. Without stakeholder collaboration and broad agreement, this ‘mid-course’ adjustment of the MDR will fail to achieve its intended outcomes and Europe will not realise its aim of delivering rapid innovation to improve patient and system outcomes.

Political pressure to push MDR 2.0 through without broad consensus may lead to flaws in the architecture and precipitate the next public health challenge. Perceived inequities will result in unhelpful strains on the system. The most obvious of these is an apparent shift of accountability further in the direction of notified bodies, while stripping away elements of the system that allow them to manage the risks they are overseeing. This needs careful consideration if the European Commission, Member States and notified bodies are going to work in harmony to manage the risk and opportunity afforded by rapidly evolving medical technology.

This challenge is amplified by the explosion of software and Artificial Intelligence applied to both the care of patients and embedded in regulatory processes. The opportunity is huge, but only if the various bodies responsible for medical device regulation work together in a spirit of collaboration and mutual respect. Because of the complexity and diversity of technologies under the regulatory umbrella, it is also essential that industry representation and expertise is effectively integrated into any regulatory change and new approaches devised for future technologies.

Creating a sustainable future for MDR 2.0

MDR changes should not be rushed and successful outcomes need to be built using data-driven, evidence-based approaches which build both consensus and long-term collaboration among stakeholders. This is particularly important in the absence of effective impact assessment that should accompany any major shift in legislation.

In my opinion, the key elements of the system that need addressing are as follows:

• The leadership vacuum: This is partly a function of the structure of the EU, where responsibility is shared between the European Parliament, the Commission and the Member States. Leadership and accountability go together and ambiguity builds potential for conflict
• Capacity and capability: The system is fundamentally under-resourced to achieve the goals built into the legislation. Member States, in particular, need more capacity and capability if they are to play a full role in counter-balancing the power conferred upon the European Commission while making a prominent contribution to running the system
• Institutional ‘glue’: This is needed to allow the participants to function effectively. The European Medicines Agency serves this purpose for medicines regulation, but would need wholesale reconfiguration if asked to perform the same role for devices (see my previous piece on the future of regulatory affairs)
• Centralised activities: Consistency of legislative and guidance interpretation requires more activities to be centralised. The most important of these is the supervision of notified bodies in order to reduce inconsistencies exacerbated by variable supervisory capability at Member State level and the paucity of unambiguous operational guidance

As Europe seeks to find the perfect balance between risk and reward, the ‘consent by the governed’ principle needs to be remembered. Collaboration is the only way forward. Anything that looks like ‘win-lose’ will falter in the long run, as will legislative ‘quick fixes’ that yield to political pressures. A focus on what delivers better outcomes for patients needs to be at the core of everyone’s objectives.