ISO 18969: What’s Actually Changing in Clinical Evaluation (And When to Prepare)

Clinical evaluation has always been foundational to medical device regulation—it's how we demonstrate safety, performance, and that elusive but critical benefit-risk balance. MEDDEV 2.7/1 rev. 4 and the cascade of MDCG guidance documents have shaped EU MDR practices, but the reality is messier: variability across jurisdictions and constantly evolving regulatory expectations create ongoing compliance challenges. Enter ISO 18969, an international consensus-based standard designed to address exactly these pain points.

As of October 2025, ISO 18969 has reached Committee Draft approved for DIS registration (ISO stage 30.99) under ISO Technical Committee 194, meaning it's progressing through international ballot but remains under development. Final publication is realistically expected in 2026 or later. Here's the catch: until official publication and harmonization—which in regions like the EU can vary considerably based on Commission standardization requests and CEN/CENELEC workflows—manufacturers must continue full compliance with current regional and global requirements, including the MDR, MEDDEV 2.7/1 rev. 4, MDCG guidance, and FDA regulations where applicable.

What ISO 18969 Brings to the Table: Practical Framework

ISO 18969 essentially consolidates clinical evaluation into a lifecycle-embedded process that:

• Covers pre-market clinical data gathering, through routine post-market surveillance (PMS), to a structured post-market clinical follow-up (PMCF).
• Emphasizes scientific rigor and transparency to ensure clinical evidence supports a credible benefit-risk determination.
• Specifies a bi-directional feedback loop between clinical evaluation and ISO 14971-compliant risk management, ensuring clinical risks identified from real-world evidence actively inform risk controls and vice versa.
• Clearly delineates roles and responsibilities for manufacturers and clinical evaluators to support accountable, reproducible clinical evaluation reports.

How ISO 18969 Changes Current Practice: A Comparison

*Upon final publication and regulatory adoption in applicable jurisdictions.

**Reporting cadence follows MDR Annex XIV and MDCG guidance (2020-7 for plans, 2020-8 for reports), determined via risk-based agreement with notified bodies—not prescribed by ISO 18969 itself.

Ask any regulatory affairs professional about clinical equivalence assessments under MDR and you’ll likely hear frustration. The current approach invites inconsistent interpretations, inconsistent Notified Body expectations, and often prolongs approvals. ISO 18969 aims to fix this by establishing a clear, structured framework for equivalence comparisons across technical, biological, and clinical characteristics. This will significantly benefit manufacturers managing families of related devices, next-generation products, and legacy device variants by potentially reducing unnecessary clinical investigations without sacrificing safety.

Putting the Risk Management Linkage Into Perspective

ISO 18969 takes the position that risk management and clinical evaluation cannot operate in silos. Clinical risks extend beyond product malfunctions to encompass procedural and user-related risks.

Here’s where it gets practical: If PMCF data reveal, for example, that infection rates for an implantable device are higher than expected, that new information requires updating the risk management file, potentially triggering root cause investigations and design or labeling changes. This "feedback loop" means clinical evidence drives risk mitigation, and updated risks in turn refine clinical evaluation. This cycle supports a proactive safety assurance model.

PMCF: More Than a Checkbox

Manufacturers who have struggled with variable notified body expectations around PMCF will find the clarity they’ve long awaited. ISO 18969 specifies PMCF plans need to include:

• Clear objectives.
• Defined data sources spanning registries, clinical investigations, and real-world evidence.
• Transparent evaluation and reporting methods.
• Reporting that follows MDR Annex XIV timelines and MDCG guidance (2020-7 for plans, 2020-8 for reports), with cadence determined through risk-proportionate agreement with notified bodies rather than ISO-prescribed schedules.

All these need to be integrated into the overarching PMS plan for a cohesive safety strategy.

Device Classes and SaMD: A Modern Take

Class III and implantable devices? These require comprehensive clinical evaluation and detailed PMCF plans—no surprises there. For Class I/II devices, the clinical evidence approach is proportionate and streamlined. And Software as a Medical Device (SaMD) adds another layer, where clinical evaluation must adapt dynamically to rapid software releases, algorithm updates, and continuous learning systems—aligning with emerging FDA and IMDRF guidance.

Harmonization: What to Expect Next

Publication is just step one. After ISO releases the standard, regulatory bodies will deliberate on official harmonization. In the EU, harmonization timelines vary considerably depending on European Commission standardization requests and CEN/CENELEC workflows—ranging from 12 months to several years post-publication, with no guarantees of rapid Official Journal citation. FDA engagement has been limited, reflecting that US clinical evaluation requirements differ substantially from the EU’s, so US manufacturers should monitor voluntary consensus standards recognition closely. Global programs like MDSAP and IMDRF also weave into this complex landscape.

How Should Manufacturers Prepare?

How should manufacturers prepare for this transition while managing current compliance obligations? The strategy requires balancing immediate regulatory demands with strategic preparation:

• Keep ISO 18969 developments on your radar and track timelines closely.
• Conduct gap analyses to compare existing clinical evaluation practices against the ISO’s lifecycle approach.
• Most importantly, don’t drop the ball on current MDR, MEDDEV, MDCG, and FDA requirements.
• Update clinical evaluation and PMCF documentation with draft-aligned concepts where applicable.
• Engage notified bodies early to align on expectations during this transition phase.
• Train cross-functional teams—clinical evaluators, RA professionals, risk managers, PMS personnel—with around 4 to 8 hours of focused instruction.
• Consider a dual documentation approach to cover current methods plus ISO 18969-aligned strategies.
• For existing marketed devices, prioritize portfolio reviews by risk class, incorporating the new framework during upcoming CER revisions, especially for high-risk devices.

Anticipated CER Changes

Prepare for CER formats to evolve post-publication, likely featuring:

• More robust risk-benefit assessments linked intimately with risk management.
• Explicit equivalence evaluation documentation.
• Integrated sections capturing PMCF data and its influence on clinical conclusions.

To Wrap Up

ISO 18969 clearly promises to streamline and strengthen clinical evaluation by embedding it into a coherent, risk-integrated lifecycle framework. Adopt it early and smartly, and your clinical evidence will not only support safer devices but also smoother regulatory pathways globally.

The bottom line? Until ISO 18969 is published and harmonized, keep playing by current rules—but do your strategic homework now.

Sources

• ISO. Clinical Evaluation of Medical Devices – ISO/CD 18969, Committee Draft available 2025.
• Qserve Group. “A New ISO 18969 – Clinical Evaluation of Medical Devices Is on the Way.” December 2022.
• European Commission MDCG 2020-7 Guidance on PMCF.
• Naveen Agarwal PhD. “Understanding the Interface Between Clinical Evaluation and Risk Management.” May 2023.
• RAPS Convergence 2023 Reports on EU MDR Clinical Evidence.
• British Standards Institution (BSI). ISO 18969 Development Timeline.
• FDA Standards Engagement Reports, 2025.