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Using international clinical data

Applies to

Both MDR 2017/745 and IVDR 2017/746. International clinical data — generated outside the EU — can be used in clinical evaluations and performance evaluations, subject to certain conditions.

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.

Can international clinical data be used?​

Yes — MDR and IVDR do not restrict clinical or performance evidence to EU-generated data. International data (e.g. from US FDA studies, Australian TGA submissions, Japanese PMDA trials) can be used, provided the data is relevant to the EU intended population and use context and meets the scientific standards expected by notified bodies.

In practice, much global device development occurs under US, Japanese, or other non-EU frameworks, and manufacturers routinely use this data in EU clinical evaluations.

What makes international data acceptable?​

Good Clinical Practice (GCP) compliance​

Studies must have been conducted to a standard equivalent to EN ISO 14155:2020 (Good Clinical Practice for medical device clinical investigations) or, for IVDs, the equivalent performance study standards. GCP-equivalent standards from other jurisdictions (FDA 21 CFR Part 812, ICH E6) are generally considered acceptable.

Population relevance​

Clinical data generated in non-EU populations is acceptable only where the patient population is clinically comparable to the EU intended population. Factors to consider:

FactorConsiderations
Ethnicity and geneticsRelevant for pharmacogenomics, certain IVD analytes, or disease presentations that vary by ancestry
Healthcare systemStandard of care differences may affect the clinical context in which the device is used
Disease prevalencePrevalence differences affect PPV/NPV for IVDs; may affect expected clinical benefit
Regulatory oversightWas the study conducted to an adequate ethical and regulatory standard?

Where population differences exist, the manufacturer must assess and document whether they are clinically significant for the specific device and intended use.

Study design and data quality​

The same critical appraisal standards apply to international data as to EU data:

  • Study design (RCT, cohort, case-control, retrospective)
  • Sample size and power
  • Endpoint relevance
  • Risk of bias
  • Statistical analysis appropriateness

Using FDA pivotal study data​

Many manufacturers seek EU CE marking after obtaining FDA clearance (510(k)) or approval (PMA). FDA pivotal studies are commonly used as a primary data source in EU clinical evaluations. Key considerations:

MDR/IVDR contextRelevance of FDA data
Clinical performanceFDA clinical data is often directly usable if the intended use is the same in both markets
EquivalenceFDA 510(k) predicates are not automatically MDR-equivalent devices; must be assessed against all three MDR criteria
Population differencesUS patient population is generally comparable for most device types; exceptions exist (genetic tests, certain infectious disease assays)
Regulatory scrutinyFDA IDE/PMA studies are GCP-equivalent and well-accepted by EU notified bodies

The FDA Summary of Safety and Effectiveness Data (SSED) for PMA devices is a publicly available source of clinical data. However, for equivalence claims, access to the full technical documentation of the predicate device (if different from the manufacturer's own device) remains required.

Data from countries with recognised regulatory systems​

Data from comparable overseas regulators can be used:

  • Australia (TGA)
  • Japan (PMDA)
  • Canada (Health Canada)
  • USA (FDA)
  • UK (MHRA)

These regulatory systems apply GCP-equivalent standards and their clinical study outputs are acceptable to EU notified bodies, subject to the same relevance assessment.

Literature data from international sources​

Published clinical literature from non-EU studies is explicitly permitted and widely used. The same systematic literature search methodology applies regardless of geographic origin:

  • Databases: PubMed, EMBASE, Cochrane, regional databases (e.g. CiNII for Japan)
  • Language: studies in languages other than English should be translated if potentially relevant and high-quality

Documenting use of international data in the CER/PER​

The CER or performance evaluation report must explicitly:

  1. Identify data sources that are international
  2. State where the data was generated and under what regulatory framework
  3. Assess population relevance and any limitations
  4. Explain why any population differences do not undermine the validity of the evidence for the EU intended use
  5. Confirm the data meets applicable GCP or equivalent standards

Official references​

ReferenceDescription
MDR Annex XIV §5Clinical data sources
MDCG 2020-5Clinical evaluation guidance — international data
EN ISO 14155:2020GCP standard — international baseline
MDCG 2021-6Sufficient clinical evidence — legacy devices with global data