Technical documentation is the foundation of EU MDR compliance. Every medical device placed on the EU market must have a complete technical file prepared by the manufacturer before CE marking. Without it, there is no CE mark — and no market access.
EU MDR Annex II defines the required content of the technical documentation that every manufacturer must compile before placing a device on the market. Annex III covers the technical documentation specifically related to post-market surveillance. Together they define everything your technical file must contain.
Self-declaration by manufacturer. Full Annex II technical file required. No Notified Body involvement for Class I unless sterile, measuring or reusable surgical.
Notified Body audit of quality management system required. Technical documentation reviewed by Notified Body on a sample basis. PSUR every two years.
Full Notified Body assessment of QMS and technical documentation. PSUR annually. For active devices intended to administer/remove medicines — clinical evaluation consultation with expert panels.
Most stringent requirements. Full design examination by Notified Body. Premarket clinical investigation generally required. Annual PSUR. Summary of safety and clinical performance mandatory.
We confirm your device classification under Annex VIII and identify the exact documentation requirements and conformity assessment route applicable to your device.
We map each General Safety and Performance Requirement in Annex I to your device and identify the standards, tests and evidence needed to demonstrate conformity with each requirement.
We prepare or review all Annex II technical documentation sections — device description, labelling, risk management file, GSPR checklist, verification and validation summary, and clinical evaluation.
We prepare the Annex III post-market surveillance documentation — PMS plan, PSUR or PMS report, and PMCF plan where required.
We prepare the EU Declaration of Conformity and ensure it accurately references the applicable MDR articles, standards and Notified Body where required.
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