EU progresses targeted revision of medical device rules amid industry pressure

The European Commission has initiated a call for evidence on its targeted revision of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), marking a significant response to mounting industry pressure for regulatory reform. The consultation, which closes on 6 October, aims to gather stakeholder input on simplifying the regulatory framework while maintaining patient safety standards.

It represents the Commission's acknowledgment that the current rules, while achieving their safety objectives, have created unintended market access barriers and administrative burdens that threaten device availability and innovation across the European Union.

Revision initiatives

The targeted revision emerges from persistent implementation challenges since the MDR became applicable in May 2021 and the IVDR in May 2022, along with complex transition timelines. According to the Commission's call for evidence, the regulatory framework has faced criticism for imposing much more demanding requirements that also apply to existing devices, alongside the limited capacities of notified bodies and the insufficient preparedness of manufacturers, leading to the risk of shortages and the disappearance of critical devices from the market.

These challenges have necessitated multiple extensions of transitional periods through a number of regulations. These include regulation 2024/1860, which imposed new supply chain notifications, phased Eudamed roll-out and revised IVDR deadlines. Current transition deadlines extend to December 2027, 2028, or 2029 depending on device type and risk classification. The Commission has been conducting a targeted evaluation of the regulations since 2024, following requests from the European Parliament underscoring the urgent need to revise the framework, numerous Member States, and industry stakeholders to simplify the medical device regulatory framework.

The call for evidence specifically notes that stakeholder groups and institutional actors have highlighted that unpredictable certification timelines and inconsistent practices across the EU are eroding the efficiency of the CE marking process, and that some regulatory requirements exceed the actual risk profile of devices, generating unnecessary costs and burdens.

Reform objectives

The Commission's initiative aims to achieve multiple objectives while preserving the fundamental structure of the current MDR and IVDR framework.

The call for evidence identifies administrative burden reduction, including reporting obligations, as a primary target for reform. The initiative also seeks to enhance the predictability and cost-efficiency of notified body certification processes. Conformity assessment requirements would be made more proportionate, particularly for low- and medium-risk devices and those serving special patient needs. Further digitalisation of procedures represents another key focus area. The Commission also aims to streamline various procedures and governance arrangements across the regulatory system. International cooperation opportunities, including reliance mechanisms where appropriate, would be expanded to benefit the EU medical device sector. Finally, the initiative seeks to better align the medical device regulatory framework with other relevant EU legislation.

The Commission expects these changes to generate "positive economic impacts across the EU" by reducing administrative burden on manufacturers and other economic operators, thereby reducing compliance costs, supporting innovation, and enabling greater device variety to reach the market more quickly. The initiative is also intended to increase EU competitiveness in medical devices and make the region more attractive for investors whilst ensuring more efficient use of notified body resources and reducing administrative burden on health institutions and Member State authorities.

EU industry response

MedTech Europe, representing the medical technology industry across Europe, has provided detailed feedback to Olivér Várhelyi , the European commissioner for health, through a letter dated 19 September 2025, outlining the organisation's priorities for the revision process.

The industry association acknowledges the immense strain on Europe's medical technology sector and emphasises that ensuring the consistent availability of a full range of existing and innovative devices to European patients represents a critical challenge. MedTech Europe argues that the EU's regulatory pathway for medical technologies must significantly improve its global competitiveness to ensure patients continue to benefit from medtech product availability, which requires substantially reducing high lifecycle costs and addressing other unintended effects of the MDR and IVDR.

MedTech Europe outlines a dual approach requiring both comprehensive legislative reform and immediate relief measures. The organisation expresses strong support for the Commission's legislative revision initiative, though this support is conditional upon delivering a regulatory framework that promotes efficiency, innovation, adaptability and sound governance. The association emphasises that meaningful reform must address both MDR and IVDR and recognise the distinct characteristics and challenges of each sector.

Central to MedTech Europe's position is the view that the notified body system is fundamental to the regulatory framework. The association advocates for its continued central role in future reforms and proposes establishing unified and accountable governance structures that would simultaneously enhance operational efficiency and strengthen the global competitiveness of the CE marking system.

For immediate relief, MedTech Europe calls for three urgent parallel measures alongside the legislative revision. The first involves harmonising notified body regulations through implementing acts that establish maximum assessment timelines, clarify notification requirements for changes, eliminate duplicative vigilance reviews, facilitate early manufacturer dialogues to set clinical expectations, and reduce re-certification burdens. The second measure encompasses pilot programmes for specialised regulatory pathways targeting orphan devices, paediatric devices, and breakthrough innovations, with expedited procedures ultimately incorporated into the revised framework to sustain investment in cutting-edge technologies. The third urgent action involves postponing recertification requirements for devices already certified under the medical technology regulations to prevent additional bottlenecks during the 2028 transition period and maintain device availability.

Implementation timeline

The Commission has established an indicative timeline of the fourth quarter this year for adoption of the revision proposal, although industry experts suggest a revision proposal in the first quarter of 2026.

The call for evidence consultation period opened on 8 September and runs to 6 October, following which the Commission will analyse stakeholder input alongside evidence collected during the targeted evaluation process.

Rather than conducting a full impact assessment, the Commission will prepare the proposal alongside an analytical staff working document that will explain the proposed measures, present supporting evidence and stakeholder perspectives, and estimate potential cost savings. This approach reflects the Commission's assessment that the revision involves focused simplification measures with limited alternatives, aimed at reducing regulatory burden and improving framework predictability while maintaining the existing legislative objectives unchanged.

The consultation strategy includes both the public call for evidence and targeted consultation activities such as surveys, workshops, and dedicated meetings, with particular focus on involving small and medium enterprises. The Commission has identified multiple stakeholder groups for engagement, including competent authorities in EU Member States and EEA states, notified bodies, economic operators and their representative associations, healthcare professionals and their associations, patient and consumer organisations, civil society organisations, independent academic experts, regulatory affairs specialists, European bodies including the European Medicines Agency, international organisations, and non-EU countries.

Osborne Clarke comment

The Commission's targeted revision initiative signals recognition that regulatory ambition must be balanced with practical implementation realities. Although the MDR and IVDR have successfully elevated safety standards, the unintended consequences on market access and innovation capacity have prompted this necessary recalibration.

MedTech Europe's comprehensive response highlights persistent industry concerns about regulatory predictability and proportionality. The organisation's emphasis on immediate relief measures alongside longer-term reform suggests that the current regulatory pressures may intensify before comprehensive solutions take effect.

The Commission's decision to forgo a full impact assessment in favour of targeted simplification measures indicates confidence that the problems are well-understood and the solutions relatively straightforward. However, the challenge lies in achieving meaningful burden reduction while maintaining the credibility of a safety and performance framework that has taken years to establish.

Businesses operating in the medical device and diagnostics sectors may find value in engaging with the consultation process, particularly given the Commission's emphasis on gathering practical examples and cost-saving estimates. The tight timeline of the fourth quarter to the first quarter of next year suggests that stakeholder input during this consultation window could significantly influence the final proposal's scope and approach.

The parallel development of immediate relief measures through implementing acts and pilot programmes may provide some breathing space, though the effectiveness of such measures will likely depend on Member State implementation and notified body capacity. Companies might consider how best to position themselves for both the short-term relief measures and the longer-term regulatory framework that emerges from this revision process.