The European regulatory framework for medical technologies has undergone a major transformation over the past decade. In 2017 the MDR and IVDR were adopted to strengthen regulatory scrutiny and oversight of medical devices and diagnostics in the EU.
The regulations significantly strengthened requirements for clinical evidence, post-market surveillance, traceability, and oversight by Notified Bodies. The aim was to improve patient safety and restore public confidence in the regulatory system following several high-profile device safety incidents.
However, implementation has proven challenging. Many manufacturers faced difficulties transitioning to the new framework, particularly due to the scale of clinical evidence requirements and limited Notified Body capacity. These challenges raised concerns about potential device availability and market withdrawals, especially for niche or legacy technologies where patient demand is low, for example orphan devices.
In response to these concerns, the European Commission began reviewing MDR and IVDR earlier than originally planned. A targeted consultation process was launched in 2025 to gather stakeholder feedback on the effectiveness and implementation challenges of the regulations.
Following this consultation, the Commission launched a targeted revision initiative, including a call for evidence and the preparation of legislative amendments aimed at simplifying certain regulatory requirements while maintaining safety standards.
At the end of 2025, the European Commission published a proposal for a targeted revision of the MDR and IVDR framework. This revision is intended to streamline regulatory procedures, improve predictability of certification processes, and support innovation and supply resilience in the European medical technology sector.
Some of the elements discussed in the revision include:
- Simplifying regulatory procedures.
- Reducing certain administrative obligations.
- Modifying conformity-assessment requirements.
- Introducing additional flexibility for specific device categories.
While these objectives aim to address genuine implementation challenges, the revision process also raises important questions; namely about how to balance regulatory efficiency with the fundamental objective of protecting patients and public health.
From the perspective of Notified Bodies, which play a significant role in assessing device safety and performance before market access, it is essential that any revision preserves the core safeguards introduced by MDR and IVDR. While improvements are needed, revisions that weaken key safeguards could create significant risks for patients and public health.
MDR/IVDR Revision - Potential Risks for Patients and Public Health
1. Lower clinical evidence requirements could increase patient harm
MDR and IVDR significantly strengthened clinical evidence expectations for medical devices and in vitro diagnostics.
If revision dilutes these requirements the potential consequences may be:
- Devices reaching the market without robust clinical evidence (e.g., Well-Established Technologies) being exempt from clinical investigations.
- Increased risk of unexpected adverse events (e.g., with the change of the equivalence criteria).
- Reduction in transparency of clinical data to patients and healthcare professionals (e.g., removal of implant cards and summary of safety and clinical performance for certain devices).
Medical devices and IVDs play a direct role in diagnosis, monitoring, treatment, and prevention of disease, so insufficiently validated products can cause immediate health consequences.
From a Notified Body perspective, clinical evidence is central to verifying device safety and performance, and any reduction in these requirements could weaken the credibility and trustworthiness of the regulatory system.
2. Reduced oversight could recreate the failures of the pre-MDR system
The MDR and IVDR were introduced to strengthen aspects of the previous regulatory framework to fully identify and manage emerging risks associated with medical devices and diagnostics. The regulations include several key additional regulatory provisions, including enhanced scrutiny by Notified Bodies, the involvement of expert panels, and strengthened post-market surveillance requirements.
The regulations revision is expected to reduce some regulatory provisions; however, there are risks, including:
- Inconsistent conformity assessment.
- Weakened safety surveillance by reducing the number of audits.
- Increased variability across the system as simplification can often lead to more ambiguity on interpretation.
The result could be regulatory fragmentation and uneven patient safety across the EU.
3. Ensuring Device Supply Without Compromising Safety
A key driver behind the revision debate is concern about device availability and certification bottlenecks. Stakeholders report delays in certification, manufacturer withdrawals, and risk of device shortages. However, addressing availability challenges by lowering safety requirements would shift risk to patients.
Better solutions include:
- Increasing Notified Body capacity.
- Improving guidance and regulatory clarity.
- Streamlining administrative processes without weakening evidence requirements.
4. Does the MDR/IVDR Revision Foster Innovation?
Although some have expressed concerns about the potential impact of MDR and IVDR on innovation, a decreased scrutiny over devices conformity assessment could create additional challenges for the development and introduction of new technologies. For example, reduced global confidence in EU certification, fragmented regulatory interpretations across Member States, or increased uncertainty around regulatory expectations could lead companies to prioritize markets with more predictable frameworks.
In this context, a predictable and robust regulatory environment remains a key factor for supporting sustainable innovation while maintaining patient trust. The support needed for start-up companies goes far beyond the MDR and IVDR. Much more is needed in this ecosystem to support earlier on key aspects, such as education and setting expectations on regulatory pathways alongside the post certification process such as reimbursement considerations.
5. Risks to public health from reduced supply transparency
Recent legislative updates have introduced obligations for manufacturers to notify competent authorities in advance of anticipated interruptions or discontinuations in the supply of certain medical devices; in particular where this could have an impact on patient care or public health. These provisions are intended to improve transparency and allow authorities and healthcare providers to prepare for potential shortages.
If such provisions were weakened or removed as part of the revision process, a number of potential consequences could arise:
- Publicly available information on the clinical data of standard of care devices will be reduced (SSCP/SSPs) meaning patients and healthcare professionals will have less access to the clinical data for the devices they use. Interruptions to diagnostic testing or treatment pathways could occur, particularly in the case where implant cards are not required to be provided, this could introduce a level of unacceptable harm to patients or delay treatments whilst further information is needed by the healthcare professionals before conducting tests or treatment.
- Potential public health implications could emerge, especially in areas where specific technologies are essential, such as companion diagnostics or devices used in critical care settings.
Maintaining transparency around potential supply interruptions is a crucial element in supporting healthcare system preparedness and protecting patients.
The Notified Body perspective: where revision should focus
From a Notified Body perspective, any revision of the regulatory framework should primarily focus on improving the efficiency and functioning of the system, while maintaining the exacting standards of safety and performance established by the regulations.
Capacity and predictability
Strengthening system capacity and improving predictability remain important priorities. This includes further expanding Notified Body capacity to meet the demand for conformity assessments and promoting greater harmonization in the interpretation and application of regulatory requirements across Member States.
Regulatory clarity
Greater regulatory clarity could also support more efficient implementation of the framework. Clearer guidance on clinical evidence expectations, together with more consistent interpretation of key MDR and IVDR provisions, would help manufacturers better understand regulatory expectations and facilitate smoother conformity assessment processes.
Targeted flexibility
The revision could also consider introducing targeted mechanisms to address specific categories of technologies that face challenges under the current framework. For example, dedicated pathways or tailored approaches could be explored for orphan devices, breakthrough technologies, or situations involving public health emergencies, while maintaining appropriate levels of oversight.
Digital infrastructure
Finally, continued progress in the development and implementation of digital infrastructure will be important for improving transparency and regulatory efficiency. In particular, the full implementation of EUDAMED could play a significant role in enhancing traceability, information sharing, and overall system transparency.
Conclusion
The ongoing revision of MDR and IVDR presents an opportunity to improve the efficiency and sustainability of the EU regulatory framework.
However, the central principle must remain clear: patient safety and public health cannot be compromised. The challenge for policymakers is not to roll back the regulatory framework, but to focus on what adds value in our system for patients and what can be improved while preserving the high standards and transparency that patients expect have a fundamental right to.
Authors:
Richard Holborow, Head of Clinical Compliance BSI
Ester Leoni, Global Regulatory Communication Manager BSI
