Using overseas clinical data
The UK MDR 2002 does not restrict clinical data by geographic origin. MHRA accepts clinical data from any jurisdiction provided it meets appropriate quality standards. MEDDEV 2.7/1 Rev.4, endorsed by MHRA, provides methodology guidance applicable to data from any source.
Principle: data quality matters, not geography
UK MDR 2002 does not require that clinical evidence come from studies conducted in the UK, or in any specific jurisdiction. Clinical data generated anywhere in the world can be used in a UK CER — provided:
- The study was conducted to appropriate quality standards (GCP, ISO 14155, or equivalent)
- The data is relevant to the device's intended purpose and the intended patient population
- The data has been critically appraised (not just cited uncritically)
- Any differences between the overseas study population and the UK intended population are considered and addressed
Key overseas data sources
EU clinical data
Clinical data from EU-conducted investigations and post-market studies is directly applicable to UK CERs. EU MDR 2017/745 clinical investigation requirements (ISO 14155, GCP) are at least equivalent to UK standards. EU registry data, EUDAMED safety data, and MDCG-endorsed evidence can all be referenced.
For devices with EU MDR CE certification, the clinical evaluation conducted for EU MDR purposes (to the rigorous Annex XIV standards) will generally exceed what is required for UK MDR 2002 purposes. Manufacturers can leverage EU MDR clinical data directly for their UK technical file.
US FDA clinical data
US clinical data from IDE (Investigational Device Exemption) studies, 510(k) substantial equivalence data, or PMA clinical trial data is acceptable, subject to appraisal. FDA Summaries of Safety and Effectiveness Data (SSEDs) are publicly available and are a valuable data source.
Japanese clinical data
Data from PMDA (Pharmaceuticals and Medical Devices Agency) regulated studies in Japan is acceptable. Japan's clinical investigation requirements are broadly comparable to international GCP standards.
Australian, Canadian, and other IMDRF member data
Data from TGA (Australia), Health Canada, and other IMDRF member country investigations is generally acceptable. Regulatory submissions to these agencies often contain clinical data packages that can be referenced in a UK CER.
Considerations when using overseas data
| Consideration | Relevance |
|---|---|
| Patient population differences | Are the overseas subjects representative of the UK intended population? Genetic diversity, disease prevalence, healthcare practices |
| Healthcare setting differences | Is the clinical environment (hospital, community, home) comparable? |
| Device variant differences | Was the overseas study conducted on the same device model/configuration? |
| Follow-up duration | Is follow-up sufficient to address UK-market claims (e.g., long-term implant performance)? |
| Comparator used | Does the overseas comparator reflect UK standard of care? |
| Regulatory context | Was the study conducted to GCP / ISO 14155? Was it IRB/ethics approved? |
| Language | Non-English data must be translated and appraised; MHRA accepts translated study reports |
Using EU MDR clinical data for the UK market
For manufacturers with EU MDR certification, the clinical evaluation package developed for EU MDR Annex XIV purposes is typically more than sufficient for UK MDR 2002 purposes, because EU MDR requirements are more prescriptive and demanding. The same CER can generally serve both markets with:
- A UK-specific cover page and regulatory reference
- Minor adjustments to reflect UK MDR 2002 ER references rather than EU MDR GSPR
- Addition of any UK-specific post-market data if available
Related pages
Official references
| Reference | Description |
|---|---|
| MEDDEV 2.7/1 Rev.4 | Clinical evaluation methodology — applicable to data from any source |
| ISO 14155:2020 | International GCP standard for clinical investigations |
| MHRA: Clinical evaluation guidance | MHRA's position on clinical evidence sources |