EU MDR regulatory intelligence
EU MDR monitoring should connect each regulatory signal to the device’s intended purpose, classification rationale, conformity route, technical documentation and post-market obligations.
Map the regulatory change
Determine whether the source changes a legal requirement, clarifies an existing expectation or introduces an implementation timeline. Record the relevant MDR article, annex, MDCG guidance or implementing act.
Review the technical-documentation impact
Where classification or intended-purpose interpretation may change, assess the controlled technical file rather than a single document in isolation.
- Annex II §1 device description and intended purpose
- Annex II §2 information supplied by the manufacturer
- Annex II §4 General Safety and Performance Requirements
- Annex II §§5–6 risk, verification and validation evidence
- Annex III PMS documentation and Annex XIV clinical/PMCF evidence
Link product and process decisions
Document whether regulatory intelligence, document control, change control, clinical evaluation, risk management, labeling and PMS procedures need revision. The result should state both the proposed action and why the source creates that action.