The MDR/IVDR Revision: Balancing Regulatory Efficiency with Patient Safety

Introduction 

The European regulatory framework for medical technologies has undergone a major transformation over the past decade. 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.  

Implementation has proven challenging. Manufacturers faced difficulties transitioning to the new framework, particularly due to the scale of clinical evidence requirements and limited NB capacity. These challenges raised concerns about potential device availability and market withdrawals, especially for niche or legacy technologies where patient demand is low. 

In response to these concerns, the European Commission began reviewing the regulations. A targeted consultation process was launched in 2025 to gather feedback on the effectiveness and implementation challenges of the regulations.  

The Commission then launched a targeted revision, including a call for evidence and the preparation of legislative amendments aimed at simplifying certain regulatory requirements.  

End 2025, the 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 MedTech sector.   

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 increase regulatory efficiency while preserving patients and public health. 

From the perspective of NBs – which play a significant role in assessing device safety and performance before market access – any revision must preserve 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

1.Lower Clinical Evidence Requirements Could Increase Patient Harm

MDR and IVDR significantly strengthened clinical evidence expectations for MD and IVDs. 

If revision dilutes these requirements, the potential consequences may be: 

• Devices reaching the market without robust clinical evidence (e.g., WET) being exempt from clinical investigations. 
• Increased risk of unexpected adverse events (e.g., change of the equivalence criteria).
• Reduction in transparency of clinical data to patients and healthcare professionals (e.g., removal of implant cards and SSCP for certain devices).

MD and IVDs play a direct role in diagnosis, monitoring, treatment, and prevention of disease. Insufficiently validated products can cause immediate health consequences.  

From a NB perspective, clinical evidence is central to verifying device safety and performance. 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/IVDR System

The MDR and IVDR were introduced to strengthen the previous regulatory framework to fully identify and manage emerging risks associated with MD and IVDs. The regulations include several key additional regulatory provisions, including enhanced scrutiny by NBs, 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 in 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. Addressing availability challenges by lowering safety requirements would shift risk to patients. 

Better solutions include: 

• Increasing NB 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 conformity assessment could create additional challenges for the introduction of new technologies. 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 innovation while maintaining patient trust. The support needed for start-ups 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 MD; in particular, where this could have an impact on patient care or public health. These provisions intend to improve transparency and allow authorities and healthcare providers to prepare for potential shortages. 

If such provisions were weakened or removed, several 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 reduced access to clinical data for device usage. 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 conducting tests or treatment.  
• Potential public health implications couldemerge, especially in areas where specific technologies are essential, such asCDx or devices used in critical care. 

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

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. Including further expanding NB 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 introduce 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.

Endnote

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 and have a fundamental right to.

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.