I. Rationale and Objectives of the Standard
ISO 18969 is intended to:
1) provide the “terminology, principles and a process” for clinical evaluation of medical devices；
2) cover the planning of clinical evaluation activities across the entire medical device lifecycle, supporting manufacturers insystematically determining “clinical benefit-risk”；
3) establish alignment with other standards within the ISO/TC 194 system (such as ISO 14155, ISO 14971, and ISO/TR 20416) formethods and process interfaces, improving consistency and auditability；
4) provide a common language for regulatory/market access requirements across different jurisdictions,reducing duplicatecompliance work.
II. Core Content of the Standard
A. Planning（Planning): clarify the scope of application, intended use,clinical question framework(e.g., population,/intervention,/comparator,/outcome,PICOand how these elements are substantively defined), data sources, and levels of evidence;
B. Evidence identification and appraisal（Appraisal): systematic searching, selection, and bias assessment; equivalence//comparability determination based on objective criteria, with bridging across biological, technical, and clinical dimensions;
C. Analysis and synthesis（Analysis and Synthesis): integrated assessment of relative effectiveness and safety, subgroup and sensitivity analyses,clinical benefit--risk evaluation；
D. report（Reporting): Clinical Evaluation Report (CER) structured presentation, traceability, and review requirements;
E. Maintenance and updates（Maintenance): linkage with Post-market Surveillance (PMS/PMCF), Real-World Evidence (RWE) periodic review and trigger mechanisms.
III. Corporate Compliance Perspective: Impact and Significance
1) from“registration-oriented clinical evaluation”upgraded to“lifecycle evidence management”：ISO 18969emphasizes process and principles, prompting enterprises to build a closed-loop system spanning R&D—registration—and Post-market Surveillance;
2) reduce cross-jurisdiction differences in“GAP”: usinginternational standards as the common language, providing a basis for alignment with the EUMDR、IMDRFframework and the clinical evaluation requirements of other markets;
3) improveCERconsistency and auditability: standardize terminology, methods, processes, and records, making communication with Notified Body (NB) smoother;
4）BenefitsHTAAlignment: A standardized evaluation process and terminology help mapCERresults more smoothly to market access/HTAassessment dimensions (such as relative effectiveness and safety), supporting(EU) 2025/2086subsequent steps and related activities;
5）Promote cross-functional collaboration:RA/QA/Clinical/Biostatistics/Medical Affairs/Market Access need to collaborate under unifiedSOPframeworks and templates to jointly produce deliverables.
IV. Reference points for proactive enterprise planning
A. andMDR/MDCGalignment:
• MDR Annex XIV impose mandatory requirements for clinical evaluation;MDCG 2020-6、2020-13and others provide“adequate clinical evidence”andCEARtemplate practices.
• EmbeddingISO 18969the methods and processes into the company'sSOPandCERtemplates can help meetNBbased onMDCGreview expectations.
B. withISO 14155/14971/20416synergy:
• clinical investigation data (ISO 14155), risk management (ISO 14971), and Post-market Surveillance (PMS) (ISO/TR 20416) together with clinical evaluation form an “evidence hierarchy”。
C. forHTA/JCA reuse:
• Use “comparability evidence” to organizeCER the key elements for subsequent reuse in(EU) 2025/2086 theJCA templates.
V. Challenges and significance of implementing the standard
Currently, medical device manufacturers face differences in clinical evaluation requirements across countries and regions, which makes compliance in global markets more complex. The introduction of ISO 18969 will help reduce these differences, provide a globally applicable clinical evaluation framework, and support consistent assessment and regulatory oversight of devices across international markets.
VI. Future outlook
The development of ISO 18969 will bring major positive changes to the medical device industry. It will not only facilitate communication between manufacturers and regulators, but also help ensure that devices undergo comprehensive performance and safety assessment before market access, ultimately providing better protection for patients. Although some time remains before final publication, the joint efforts of experts worldwide are ensuring the quality and applicability of this standard.
VII. Industry Commentary
• The industry generally views this as a “game changer” opportunity;
• Compared with existing EU, U.S., and other regulatory frameworks: the standard is intended to provide a “unified” and “structured” global framework, rather than one limited to a single region;
• Potential benefits for manufacturers include: reducing the burden of repeated clinical evaluations/reports caused by regional regulatory differences; improving process transparency and scientific rigor;
• Regulatory and compliance significance: as manufacturers expand into global markets, they may be able to cite this standard as a compliance basis or supporting documentation.
References
• ISO/DIS 18969 standard page (official): https://www.iso.org/standard/85514.html
• ISO/TC 194 (Biological and clinical evaluation of medical devices): https://www.iso.org/committee/54508.html
• Reference background standards:ISO 14155:2020（Medical device clinical trialsGCP） https://www.iso.org/standard/71690.html