Following the European Commission’s proposal to simplify the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), published on December 16, 2025, negotiations are progressing rapidly in the European Parliament (EP) and the Council of the European Union. The proposal aims to reduce the regulatory burden, improve device availability and support innovation and competitiveness while maintaining a high level of patient safety.
In the EP, MEP Oliver Schenk, rapporteur in the Committee on Public Health (SANT), published his draft report, setting out the Committee’s initial position. Member States are also examining the proposal in the Council, with both institutions seeking to advance negotiations quickly.
For people living with diabetes (PwD), the outcome will have direct implications. Devices such as blood glucose monitors, continuous glucose monitors (CGMs), insulin pumps and automated insulin delivery systems are essential to daily diabetes management. Given the important role that medical devices play in diabetes treatment and management, the revised framework should support continued innovation and ensure that new and existing devices can reach users in a timely manner. At the same time, it must guarantee that devices placed on the EU market are safe, reliable and supported by robust evidence.
Why is the MDR being revised?
The MDR and IVDR govern the assessment, certification and availability of medical devices and in vitro diagnostic devices across the European Union (EU). While the regulations were introduced to strengthen patient safety, their implementation has created challenges, including lengthy and unpredictable certification procedures, inconsistent approaches among notified bodies (the organisations authorised to assess and certify medical devices) and a high administrative burden. These difficulties have contributed to concerns about devices being withdrawn from the EU market thereby reducing patient access to vital devices. The Commission’s proposal seeks to address these challenges by simplifying certification procedures, reducing unnecessary requirements through a risk-based approach, improving predictability, accelerating pathways for breakthrough and orphan devices and strengthening EU-level coordination.
Greater efficiency must not come at the expense of safeguards ensuring patient safety
IDF Europe welcomes efforts to streamline procedures, improve regulatory consistency, strengthen coordination and EU level and support timely access to innovative technologies. The Commission proposal represents a broader shift towards simplified pre-market assessment and greater reliance on post-market oversight. This includes more flexible approaches to clinical evidence, the replacement of recertification with periodic reviews and reduced systematic scrutiny for some medium- and high-risk devices. However, post-market surveillance cannot be a substitute for a rigorous assessment of safety and performance before a device reaches users. Where pre-market requirements are simplified, post-market monitoring, transparency and incident-reporting systems must be reinforced accordingly. The current proposal does not yet provide all the safeguards necessary to achieve this balance.
IDF Europe is therefore calling for:
- EU-wide and device-specific requirements that promote consistent assessments across MS and notified bodies
- The proactive development of Common Specifications where harmonised standards are absent or insufficient
- Publicly accessible and comparable clinical, safety and performance information through EUDAMED
- Strong and user-friendly systems through which patients, carers and healthcare professionals (HCPs) can report device problems
- The systematic involvement of people with lived experience in expert panels and regulatory decision-making.
The SANT position: positive steps, but further changes are needed
The SANT draft report contains several welcome measures to improve regulatory efficiency and predictability alongside recognising that simplification must not come at the expense of patient safety. However, some proposed changes risk weakening essential safeguards and should be reconsidered.
In particular, IDF Europe is concerned by proposals to allow information for devices intended exclusively for professional users to be provided only in English. Language requirements are not merely an administrative matter; they are essential to the safe and accurate use of medical devices. HCPs should have access to information in their working language, as their ability to understand complex safety and operating information in English cannot be assumed. Member States should therefore retain responsibility for determining appropriate language requirements within their healthcare systems.
We are also concerned by proposals to reduce the frequency of Periodic Safety Update Reports (PSURs) for non-implantable class IIb devices. These reports require manufacturers to assess real-world safety and performance data and help determine whether devices continue to perform safely after entering the market. Reducing their frequency could create gaps in oversight for technologies such as CGMs, which are used every day and directly inform treatment decisions. A device being non-implantable does not necessarily mean it has less impact on patient safety, and the rules should reflect how devices are used in practice.
Finally, the SANT amendments propose that notified bodies should accept evidence from previous assessments carried out by the same or another notified body. While drawing on existing evidence can help avoid unnecessary duplication, notified bodies must still exercise independent judgement. Requiring them to accept earlier assessments could allow weaknesses or inconsistencies in the original evaluation to be carried forward rather than identified and corrected.
Beyond these specific concerns, greater ambition is required to improve transparency. The obligation to publish a Summary of Safety and Clinical Performance should continue to cover all class IIb devices. Structured public summaries of post-market safety findings should also be made available through EUDAMED, allowing users and HCPs to understand whether devices continue to perform as expected after entering the market.
An opportunity to build a more balanced framework that supports innovation and patient safety
The revision of the MDR and IVDR is an opportunity to address regulatory bottlenecks and strengthen Europe’s capacity to develop and provide access to innovative medical technologies. However, efficiency, competitiveness and patient safety should not be treated as competing objectives. A predictable and well-functioning framework, underpinned by high and consistent safety standards, can support all three.
As negotiations continue, we call on the EP and MS to ensure that simplification does not weaken the safeguards on which patients rely. For PwD and other users of devices, trust in medical devices depends not only on their availability, but on confidence that they have been rigorously assessed, remain subject to effective oversight and continue to perform safely and reliably in everyday use.
