EU MDR technical documentation for CE marking.
The EU Medical Device Regulation raised the evidence bar for the European market. REGARA compiles Annex II/III technical documentation your notified body can audit line by line.
The EU Medical Device Regulation (MDR 2017/745) replaced the older directives and significantly raised the requirements for placing a device on the European market. CE marking under the MDR requires a complete technical documentation file per Annexes II and III, conformity with the General Safety and Performance Requirements (GSPR), and, for most devices, review by a notified body.
The MDR strengthened expectations around clinical evaluation, post-market surveillance, and traceability (UDI/EUDAMED). Many manufacturers found existing files no longer sufficient, and notified-body capacity became a bottleneck as the transition deadlines approached.
REGARA compiles technical documentation to the MDR’s structure — mapping each GSPR to its evidence, keeping the clinical evaluation current, and making the whole file navigable for auditors.
- 01Annex II/III compilation
Structure the technical documentation exactly to the MDR annexes, so a notified-body reviewer finds what they expect where they expect it.
- 02GSPR conformity mapping
Map each General Safety and Performance Requirement to the standard, test, or rationale that demonstrates conformity — with gaps flagged.
- 03Clinical evaluation support
Keep the clinical evaluation report and its literature base current and traceable, aligned to MDR expectations.
- 04Post-market linkage
Connect PMS and PSUR obligations back to the technical file so surveillance evidence stays consistent with your claims.
Why the MDR is harder than the directives.
Clinical rigor.
The MDR demands stronger clinical evidence and ongoing evaluation. Thin legacy files no longer clear a notified-body audit.
Auditable by design.
Notified bodies review line by line. A file where every GSPR links to its evidence moves faster and with fewer findings.
The bottleneck.
Limited notified-body capacity rewards submissions that arrive complete and consistent. Rework is the enemy of a timeline.
- QWhat is EU MDR technical documentation?
Under the EU Medical Device Regulation, technical documentation (per Annexes II and III) is the complete file demonstrating a device’s conformity — device description, GSPR conformity, design and manufacturing information, clinical evaluation, and post-market surveillance. A notified body reviews it before CE marking for most devices.
- QWhat are the GSPR?
The General Safety and Performance Requirements are the essential requirements in MDR Annex I that every device must meet. Manufacturers demonstrate conformity by mapping each applicable requirement to a harmonized standard, test result, or documented rationale.
- QHow is the MDR different from the old MDD?
The MDR raised requirements across clinical evidence, post-market surveillance, traceability (UDI/EUDAMED), and notified-body oversight. Many devices need stronger clinical data and more thorough documentation than the previous directives required.
- QHow does REGARA help with CE marking?
REGARA compiles technical documentation to the MDR annex structure, maps every GSPR to its supporting evidence with gaps flagged, keeps the clinical evaluation current, and links post-market obligations back to the file — producing an auditable technical file for your notified body.
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Make your MDR file audit-ready.
Bring a device. In a 30-minute working session we’ll map GSPRs to evidence and structure your Annex II file.