Regulatory Intelligence & Knowledge Centre

What stays FDA-specific. The regulation keeps requirements beyond ISO 13485, including content requirements for complaint and servicing records, UDI, and labelling and packaging controls, and links to medical device reporting and corrections and removals.

Terminology. The QSR terms design history file, device master record and device history record are no longer defined. Legacy records remain useful, but their content must satisfy the ISO 13485 clauses that now apply.

Four practical steps. Review management review records as if an investigator will read them. Reconcile legacy DHF, DMR and DHR content. Check that complaint records capture the MDR reportability determination. Run a QMSR-style mock inspection.

Scientific validity shows the association between the analyte and the clinical condition or physiological state, from literature, consensus and proof-of-concept data.

Analytical performance shows the device detects or measures the analyte correctly: precision, trueness, limits of detection and quantitation, analytical specificity, interference, measuring range and stability.

Clinical performance shows results correlate with the clinical condition in the intended population: diagnostic sensitivity and specificity, predictive values and expected values.

Common gaps. Scientific validity resting on a single source; analytical studies on one reagent lot; clinical claims beyond the studied population; PMPF plans not linked to residual uncertainties.

Protocol first. Agree questions, databases, search strings and inclusion criteria before searching, and record any deviations.

Reproducible searches. Record databases, dates, full strings and hit counts so anyone can repeat the search.

Appraisal and traceability. Document why each source was included or excluded, how it was appraised and which conclusion it supports.

Common gaps. Strings that cannot be rerun, no appraisal criteria, favourable sources only, and conclusions with no traceable source.

Where AI helps. Consistent coding, first-pass seriousness screening, surfacing similar past events and tracking every clock that applies to one event.

Where people decide. Judgements about seriousness, causality and whether an event could have led to serious harm. These need clinical and regulatory judgement, and the manufacturer owns the decision.

What does not change. The manufacturer's legal reporting obligations, whatever tools and service providers it uses.

What transfers. Test data, risk management and a QMS aligned with ISO 13485 through Ministerial Ordinance No. 169.

What changes. MDR Annex II documentation structure, clinical evaluation and PMCF expectations, FDA predicate logic for 510(k), and an EU Authorised Representative or US Agent.

Our route. AI-assisted gap assessment of the existing dossier, expert delta review, targeted remediation, submission support until certification, then post-market and complaint handling.