Evidence may carry over; an approval does not

Testing, risk-management records, quality-system evidence, clinical or performance data, software documentation, complaint trends and post-market records may all support an EU review. Their value depends on whether they cover the same legal manufacturer, device configuration, intended purpose and claims proposed for the Union market.

The required EU technical-documentation structure is set out in Annexes II and III of the MDR and IVDR.

Use a three-way evidence map

Reuse

Current test reports, design records or post-market data may be referenced directly when their scope, methods, device identity and conclusions support the proposed EU device.

Adapt

Home-market documents often need an EU-specific rationale, terminology, cross-reference or gap analysis. A strong FDA, Health Canada or Swissmedic record can be an excellent input without being the final MDR or IVDR document.

Create

The EU classification rationale, general safety and performance requirements mapping, EU declaration of conformity, EC REP mandate, Union labelling, applicable UDI data and EUDAMED workstream remain jurisdiction-specific.

Where evidence mapping usually fails

• the home-market product family is broader or narrower than the proposed EU portfolio;
• the intended purpose or promotional claims differ;
• the tested configuration is not the configuration to be sold in the EU;
• clinical, performance or post-market evidence is outdated or cannot be traced to controlled records;
• local registration is treated as a substitute for EU conformity assessment.