Consultation to Simplify EU Rules for Medical Devices

The European Commission has recently opened its consultation for the revision of the EU’s rules for medical devices and in vitro diagnostics. We outline how this initiative seeks to resolve the issues faced by manufacturers under the current regulatory framework. We also examine what the potential revision may mean for relevant stakeholders in the industry.

The European Commission launched its call for evidence, as part of an initiative to simplify EU rules for medical devices and in vitro diagnostics under the MDR/IVDR, on 8 September 2025. The call for evidence follows the Commission’s targeted evaluation of the EU rules on medical devices and in vitro diagnostics that was launched in late 2024. These revisions seek to reduce the administrative burden faced by developers of medical devices in the EU in order to streamline and future-proof the Union’s regulatory framework. The initiative plans to achieve this by tackling the key issues faced by manufacturers in the industry under the current regulations.

The initiative cites a lack of predictable timelines in the certification process and overly high costs and burdens as problems currently faced by medical device manufacturers operating under the current regulatory framework. In effect, these issues may result in the delay or discontinuance in the supply or launch of medical devices, which in turn may potentially impact the level of patient care and public health in the EU. Additionally, these consequences of the EU’s overly stringent rules may negatively impact the competitiveness of the EU on the global medical device market.

The initiative aims to simplify the regulatory framework by taking measures such as:

• Reducing the administrative burden for medical device manufacturers, including reporting obligations

• Enhancing the predictability and cost-efficiency of the certification processes, and

• Introducing greater extent of proportionality to conformity assessment requirements, particularly for low and medium risk devices.

Over the course of the consultation period, the Commission hopes to collect the views and insights of relevant stakeholders on the objectives of the proposed revisions. The consultation process includes the ongoing call for evidence for interested parties through the EU's Have Your Say platform. A series of targeted consultation activities, including surveys, workshops and dedicated meetings will then follow. While the initiative aims to place a particular focus on SMEs, the main stakeholder groups identified as part of the consultation process include:

• The competent authorities in EU Member States and EEA States

• Notified bodies involved in the conformity assessment of medical devices

• Economic operators in the medical devices field

• European bodies, including the European Medicines Agency

• Healthcare professionals

• Patients and consumers.

The initiative also invites input from researchers and academic organisations. Submissions may include scientific research, analyses or data that summarises the current state of knowledge in the relevant fields.

Next steps

The feedback period remains open until 6 October 2025, with adoption by Commission scheduled to take place in the fourth quarter of 2025. We encourage stakeholders to participate fully in the consultation, as any simplification of the rules and reduction in cost burdens will be widely welcomed by the industry.

For more information and expert advice, contact a member of our Products team.

The content of this article is provided for information purposes only and does not constitute legal or other advice.