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5 min read
Article 61 of the EU Medical Device Regulation (MDR) 2017/745 fundamentally reshaped expectations for clinical evaluation by placing explicit responsibility on manufacturers to demonstrate sufficient clinical evidence for conformity. Unlike previous regulatory frameworks, MDR requires manufacturers to actively justify the adequacy, relevance and robustness of their clinical evidence rather than relying on historical acceptance or procedural compliance.
For both legacy devices transitioning from the Medical Devices Directives (MDD/AIMDD) and newly developed devices, Article 61 has become a focal point of Notified Body scrutiny. Understanding how sufficiency is assessed, documented and defended is therefore became essential for MDR compliance.
What “Sufficient Clinical Evidence” Means Under Article 61
EU MDR Article 61 does not define sufficiency through fixed data thresholds. Notified Bodies primarily assess sufficiency in context, considering device risk class, intended purpose, clinical claims, state of the art (SOTA), availability of alternative treatments, and the extent to which clinical evidence demonstrates conformity with the applicable General Safety and Performance Requirements (GSPRs). These requirements must be understood within the broader framework of clinical evaluation and performance evaluation under EU MDR.
This reflects the MDR’s shift toward evidence-based decision-making, requiring clinical evidence to demonstrate intended clinical benefit and an acceptable benefit risk profile relative to current clinical practice. Accordingly, sufficiency is assessed in a proportionate and contextual manner, as reinforced by MDCG 2020-6, which emphasizes that manufacturers must justify the quality, relevance and adequacy of clinical evidence, not merely the quantity.
Challenges for Legacy Devices Transitioning to MDR
Clinical evaluation for legacy devices under Article 61 has historically relied on equivalence or long market history. Notified Bodies expecting manufacturers to reassess whether existing evidence remains sufficient considering current SOTA, evolving clinical practice and post-market experience.
Common challenges include the use of outdated literature, limited clinical investigation data and equivalence claims that no longer comply with the stricter requirements of the MDR. Reliance solely on market history is insufficient for clinical evaluation of medical devices, instead a structured and transparent reassessment of clinical evidence is mandatory, especially for higher-risk devices.
Clinical Evidence Expectations for New and Innovative Devices
For new devices, Article 61 expectations are equally demanding but take a different form. Notified Bodies expect manufacturers to demonstrate that clinical evidence has been generated proactively and systematically, rather than inferred from analogous products. Clinical investigations which are often mandatory for novel technologies or indications are scrutinized to ensure that study designs, endpoints and patient populations directly validate the intended clinical claims. In this context, sufficiency is closely tied to how well clinical evidence aligns with the defined SOTA.
The Role of Literature and SOTA in Evidence Sufficiency
Literature-based evidence remains a cornerstone of clinical evaluation, has evolved under Article 61. Notified Bodies now expect literature to be critically appraised and clearly linked to the device’s intended purpose and clinical claims.
Systematic identification and evaluation of relevant literature help establish both SOTA and contextual benchmarks for sufficiency. These expectations align with the methodological principles described in MEDDEV 2.7/1 Revision 4 – Clinical Evaluation, which continues to inform Notified Body assessments despite predating MDR.
Well-defined medical device literature search protocols and critical reviews are essential, particularly when clinical investigations are limited or when equivalence is used to supplement the evidence base.
Equivalence Under Article 61: Narrower and More Defensible
Equivalence remains permissible under MDR, but Article 61 significantly narrowed its practical applicability. Notified Bodies now require a comprehensive demonstration of technical, biological and clinical equivalence, supported by sufficient access to comparator data.
Where equivalence is claimed, manufacturers must justify why equivalence-based evidence remains sufficient relative to current SOTA. In many cases, equivalence alone is no longer enough and must be supplemented with post-market clinical follow-up or new clinical investigations.
This examination has made equivalence one of the most common sources of Article 61, related nonconformities during MDR assessments.
Lifecycle Integration and Ongoing Evidence Sufficiency
A defining feature of Article 61 is its lifecycle orientation. Clinical evidence sufficiency is not assessed only at initial certification; it must be maintained throughout the device’s market life.
Notified Bodies routinely assess whether Clinical Evaluation Reports remain aligned with post-market surveillance (PMS), periodic safety update reports (PSURs), and post-market clinical follow-up (PMCF) activities. These expectations are reflected in MDCG 2020-7 and broader MDCG guidance on PMS integration.
Embedding clinical evaluation within broader medical device lifecycle management practices ensure that emerging data is systematically assessed and incorporated into updated sufficiency justifications.
Special Considerations for SaMD and AI-Based Devices
For Software as a Medical Device (SaMD) and AI-enabled technologies, demonstrating sufficient clinical evidence under Article 61 presents additional complexity. Clinical performance may evolve over time due to algorithm updates, adaptive learning or expanded use environments.
Regulatory expectations in this area are shaped by IMDRF guidance on Software as a Medical Device (SaMD) and evolving perspectives from European Medicines Agency (EMA) on digital health and artificial intelligence. Manufacturers must clearly explain how evidence sufficiency is maintained as software evolves.
Conclusion: Making Article 61 Defensible in Practice
Article 61 has transformed clinical evaluation from a documentation exercise into a continuous, evidence driven regulatory discipline. Notified Bodies expect manufacturers to actively justify the sufficiency of clinical evidence, considering SOTA, clinical risk and post-market experience.
For both legacy and new devices, defensibility under Article 61 depends on transparent methodology, robust evidence appraisal and lifecycle integration. Manufacturers that approach sufficiency as an evolving obligation, rather than a one-time hurdle are better positioned to meet Notified Body expectations and sustain long-term MDR compliance.
How Freyr Supports Article 61 Clinical Evaluation
Demonstrating sufficient clinical evidence under Article 61 requires a structured, defensible approach tailored to both device maturity and clinical risk. At Freyr, we support manufacturers in assessing clinical evidence gaps, strengthening Clinical Evaluation Reports and aligning evidence strategies with state-of-the-art benchmarks and lifecycle requirements.
Freyr’s experts help manufacturers address Notified Body questions, remediate legacy device CERs and design evidence strategies for new and innovative technologies, including SaMD and AI-based devices. For support related to Article 61 compliance, CER development or clinical evidence strategy under EU MDR, speak to a Freyr expert to discuss your specific regulatory challenges.
