I. Regulations/Purpose and positioning of the standard
• Implementing Regulation (EU) 2025/2086（JCAImplementing Regulation)
Purpose:Under theHTA parent Regulation (EU) 2021/2282 , establish an EU-level joint clinical assessment for medical devices andIVD (JCA)JCA-joint clinical assessments）processes, roles, timelines, and templates to scientifically compare relative effectiveness and safety and reduce duplicate assessments by Member States, and provide a harmonized clinical comparative evidence basis for Member States’ market accessdecisions.
Key points:Periodic decisions on the selection of product categories for inclusion; manufacturers7/60/100/165/30days and other hard deadlines;Annex I–V templates; the boundaries between confidentiality and disclosure; restart/update mechanism.
• ISO 18969（Clinical evaluation of medical devices）
Purpose:Providean internationally recognized process framework and methodological requirementsfor the clinical evaluation of medical devices throughout the product’sfull lifecycle(planning,→evidence collection,→evaluation,→reporting,→maintenance and updates), emphasizingrisk-clinical integrated judgment of benefit-risk andalignment with other standards (such asISO 14971、ISO 14155、ISO/TR 20416process alignment among these and similar standards).
Significance:Asan internationally recognized consensus standard, it provides manufacturers with“how to do it”methods and documentation requirements, facilitating alignment with regulatory requirements across multiple jurisdictions.
• MDRandMDCG guidance
MDR：the EU MDR, the foundational law for medical devices in the EU, which sets out clinical evaluation (Annex XIV), clinical evidence, andPMCFother mandatory requirements.
MDCG：WithinMDRthis framework, it provides operational guidance, such as:
MDCG 2020-6: determining whether legacy devices meet theMDRunder“sufficient clinical evidence”requirement;
MDCG 2020-13：CEARtemplates (NBassessment records for a company's clinical evaluation);
MDCG 2020-1: clinical/performance evaluation guidance for medical device software.
II.The relationship and key differences among the three
• MDR is mandatory“foundational regulation”；
• MDCG the guidance provides“underMDRhow to do it”forspecific explanations and templates；
• ISO 18969 providesinternationally accepted“methodologies and processes”standards, which can serve as a foundation for establishing an enterpriseQMS/clinical evaluation systembest practice；
• (EU) 2025/2086 takes the perspective of“market access/HTA”and, from that perspective,“how to organize cross-country joint comparative assessments (JCA）”providing processes and templates, and translating a company's clinical evidence into comparative conclusions that can be jointly adopted by Member States.
In short:MDR/MDCG ensures“can reach the market”；ISO 18969 ensures“Make clinical evaluation systematic and traceable”；2025/2086 Ensure“it can be assessed in a unified, standardized, and transparent manner for coordinated market access”。
3. Evidence loop and document linkage
The clinical evidence lifecycle (planning→generation→aggregation→assessment→maintenance) should be built systematically and reused across multiple areas:
• study/data layer: clinical trials (ISO 14155）、RWE/registration (ISO/TR 20416), risk management (ISO 14971）→ build a database;
• evaluation/report layer: conduct clinical evaluation according to ISO 18969 and produceCER(orPER）；
• review/compliance templates: use MDCG 2020-13 of theCEARTemplate supportNBreview; for legacy devices, use as a referenceMDCG 2020-6to assess adequacy;
• HTA/Access layer: turnbased onPICOrelative effectiveness/safety comparison evidence, reuse and output according to (EU) 2025/2086 theAnnex III/IV/V template for use inJCA。
IV. Corporate compliance strategy and early positioning
A. system setup
1) Establish“clinical evaluation managementSOP”: led byISO 18969, linked toISO 14971(risk),ISO 14155(clinical trial),ISO/TR 20416（PMS）mapping；
2) set up“JCAresponse team”: coordinate with(EU) 2025/2086timelines and templates; registration, clinical,HTAquality, statistics, and data engineering roles, and other compliance system setup;
3) Document engineering: transformCER/PERstatistical plans, search records,PMCFand standardize materials to ensure traceability and version control.
B. Evidence planning
1) with“futureJCAofPICO”as the core principle, assess whether the comparator/endpoints/and follow-up are adequate, and supplement with additional studies or registries when necessary;
2) PrebuildJCAdatabases: in accordance withAnnex I/II operations；
3) Confidential information management: establish standards for asserting trade secrets and alternative databases, and train the team on protection mechanisms.
C. Practical response
1) and member states/HTAecosystem engagement: use Joint Scientific Consultation (JSC) or early methodological exchanges to reducePICOmismatch risk;
2) Establish“milestone”a mechanism:7/60/100/165/30a countdown board and alerts, and assign backup owners;
3) RWE/Update strategy: for(EU) 2025/2086 the update of/preconfigure a restart mechanism with real-world data and follow-up milestones.
V. Typical Challenges and Strategies
• PICOMismatch → Early-stageJSC+Protocol strategy;
• Evidence“Sufficient for market access, but not for comparison” → Pre-specify comparative controls and patient-centered outcome measures in the clinical protocol (Safety&performance parameters &AC&Clinical Benefits& SOTA）；
• Document fragmentation → Establish a unified“evidence-to-template”evidence repository (CER→CEAR→JCA Annex）；
VI. References and Original Links
• (EU) 2025/2086（EUR-Lex OJ）：https://eur-lex.europa.eu/eli/reg_impl/2025/2086/oj/eng
• European Commission JCA Topic page:https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-clinical-assessments_en
• ISO 18969 (ISO official standard page): https://www.iso.org/standard/85514.html
• MDR (EU) 2017/745（EUR-Lex）：https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng
• MDCG 2020-6 (sufficient clinical evidence - legacy devices): https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_6_guidance_sufficient_clinical_evidence_en_0.pdf
• MDCG 2020-13 (CEAR template): https://health.ec.europa.eu/document/download/d1f5f404-0ab8-4ab6-9165-28885c645e74_en
• MDCG 2020-1 (clinical/performance evaluation for software): https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_1_guidance_clinic_eva_md_software_en_0.pdf