The MDR/IVDR Revision: Impact on Clinical Evaluations and Clinical Investigations

Balancing Regulatory Simplification with Patient Safety

The European Commission has proposed revisions to the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). While these proposals aim to improve proportionality and reduce administrative burden, they are not yet law and will undergo extensive discussion before any adoption. 

Simplification is necessary in parts of the current system. However, efficiency gains must not come at the expense of clinical evidence and patient safety. From a Notified Body perspective, several elements of the proposal introduce structural risks that could weaken the clinical evaluation framework and reduce oversight of devices entering the European market. 

A central concern is the expansion of the Well-Established Technology (WET) concept, which creates a pathway for reduced requirements across multiple areas: clinical investigations, transparency tools, traceability, and notified body assessment. Taken together, these changes risk enabling market access based on assumptions rather than evidence. 

WET Expansion: From Proportionality to Rising Risk

The intention behind WET list expansion is understandable: long-established technologies with proven safety should not be subject to unnecessary regulatory burden. However, the proposed definition lacks sufficient precision and safeguards. 

In its current form, manufacturers may be able to classify devices as WET based on broad “generic device group” arguments, even where there is limited or no direct clinical evidence for the specific device. This creates a strong incentive to pursue WET status not because a technology is well established, but because it allows to limit the application of key regulatory obligations. 

Without clearer boundaries, the WET concept risks becoming a pathway through which higher-risk or insufficiently evidenced devices can enter the market. 

Clinical Investigation Exemption: A Shift Away From Evidence

One of the most significant consequences of WET expansion is the exemption from clinical investigations. Clinical investigations remain the most reliable method to demonstrate safety and performance in real-world conditions. Allowing devices – particularly those claiming clinical benefit – to bypass this requirement introduces a fundamental evidence gap at the point of market entry. 

In such cases, clinicians are left without robust data to support decision-making. The absence of comparison data, limited understanding of device-specific risks, and lack of validated performance claims make it difficult to determine which device is most appropriate for patients. This effectively shifts the burden of evidence generation from the pre-market phase to post-market use, where risks are borne directly by patients.

Reduced Notified Body Scrutiny: The Sampling Problem

The proposal also introduces a fundamental change in how high-risk WET devices are assessed. Instead of product certification – where all devices in a product family are reviewed prior to approval – the system would rely on quality management system (QMS) certification with sampling. 

Under this model, only one device is assessed at the time of certification, with additional devices reviewed periodically, potentially at a rate of one per year. The remaining devices may enter the market without prior notified body assessment, sometimes for extended periods. 

This creates a substantial oversight gap. For manufacturers with large portfolios, it may take decades before all devices are independently reviewed. During this time, devices (including implantable and high-risk products) may be used in patients without verification of their clinical evidence or performance. 

Removal of SSCPs: Loss of Clinical Transparency

The expansion of WET device eligibility means that technologies meeting these criteria will no longer require a Summary of Safety and Clinical Performance (SSCP). The proposed exemption from SSCP requirements further compounds the problem. SSCPs play a critical role in translating complex clinical data into accessible information for clinicians and patients. They enable comparison between devices, support informed clinical decisions, and provide transparency on the strength of available evidence. Removing this requirement reduces visibility into the clinical basis of devices, particularly in areas where multiple products exist for the same indication. In such an environment, clinicians may be unable to distinguish between devices supported by robust data and those relying on limited or indirect evidence. A more proportionate approach would be to simplify SSCPs – ensuring they remain concise and accessible – rather than removing them entirely. 

Implant Card Exemption: Practical Risks for Patients

Expanding WET device eligibility would lead to the removal of implant card requirements, thereby introducing immediate and tangible risks to patient safety. Implant cards provide essential information about the device, including identification, traceability, and critical safety considerations such as MRI compatibility. They are particularly important in emergency situations or when patients receive care outside their original treatment centre. Without this information, clinicians may lack the data needed to make safe decisions during medical procedures. The risks associated with implants (such as device interference or contraindications) do not disappear because a device is classified as WET.

Clinical Evaluation: Normalising the Absence of Data

Changes to Article 61(10) and related clinical evaluation provisions suggest a broader shift away from evidence-based requirements. By removing the notion of “exception” and allowing greater reliance on preclinical data and generic device group information, the proposal risks making the absence of clinical data a more common and accepted pathway – particularly for Class IIa and IIb devices. This introduces ambiguity and inconsistency. Manufacturers may design clinical evaluation strategies that avoid generating data, while notified bodies may still expect evidence at the point of assessment. The result is inefficiency, misalignment, and potential delays – alongside increased clinical risk. At its core, clinical evaluation should remain grounded in a simple principle: devices should be supported by clinical data demonstrating their safety and performance. Departures from this principle should remain rare and well justified. 

Equivalence: Weakening the Scientific Basis

The proposed shift from “same” to “same or similar” across technical, biological, and clinical characteristics significantly weakens the concept of equivalence. Equivalence is intended to allow the use of existing clinical data where devices are truly comparable. Expanding this to “similar” risks undermining the scientific validity of that comparison. If devices differ in design, materials, or intended use – even to a moderate degree – their clinical performance may also differ. Relying on such data introduces uncertainty and increases the risk that safety or performance issues remain undetected. Moreover, the subjective nature of “similarity” is likely to lead to divergent interpretations across stakeholders, resulting in inconsistent levels of patient protection across Europe. 

PMCF: Reduced Structure, Reduced Accountability

Post-market clinical follow-up (PMCF) remains a cornerstone of the clinical evidence lifecycle. It provides real-world data that confirms long-term safety and identifies emerging risks. While integrating PMCF into the Clinical Evaluation Report may reduce administrative burden, the removal of a dedicated PMCF evaluation report risks reducing visibility and accountability. Without a clearly defined structure, there is a greater likelihood that new evidence is not fully captured or adequately reflected in benefit–risk assessments. Flexibility in reporting timelines is appropriate, but it must be balanced with mechanisms that ensure completeness, traceability, and timely evaluation of emerging data. 

Clinical Consultation: Gaps in Independent Oversight

The proposed changes to the clinical consultation procedure risk further weakening independent scrutiny of high-risk devices. By narrowing the scope of devices subject to expert panel review and maintaining misalignment between expert panels and notified bodies, the system may fail to identify critical clinical issues at an early stage. A more effective approach would strengthen collaboration, ensuring that expert input is integrated both early and throughout the assessment process, particularly for novel or high-risk technologies. 

Protecting the Clinical Foundation of the Regulatory System

The MDR/IVDR revision presents an opportunity to improve efficiency and proportionality within the regulatory system. However, some of the proposed changes risk undermining the clinical evidence framework that ensures patient safety. Expanding WET without strict definition, reducing clinical investigation requirements, weakening equivalence criteria, and removing transparency tools collectively shift the system toward reduced evidence and oversight. Patient safety depends on maintaining a clear principle: every device placed on the market should be supported by sufficient, device-specific clinical evidence. Efficiency should refine this process – not replace it. 

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.