Medical Device Regulatory Intelligence Glossary

The category

Regulatory intelligence

The practice of continuously collecting, consolidating and cross-referencing what regulators and the open market publish about your medical devices — adverse events, recalls, safety and enforcement notices, and unauthorized listings — so decisions are made from one current view rather than scattered manual searches. See the full category guide.

Regulatory intelligence software

The category of tools that automates regulatory intelligence: consolidated device lookups across regulators, continuous watchlist monitoring, open-market surveillance, and evidence capture feeding compliance reports. Complements a QMS (internal records) by covering external signals.

Gap Scan™ MedFortis term

MedFortis's free 30-minute diagnostic session: the platform is run live against a manufacturer's device lines to reveal what is currently surfacing across six regulators and the resale market — showing surveillance gaps before any commitment.

Obligations & reports

Post-market surveillance (PMS)

The systematic monitoring of a medical device after it reaches the market — collecting and analysing real-world data on safety and performance. A legal obligation under EU MDR Articles 83–92 and expected under FDA 21 CFR 820.

PMS plan

The document (EU MDR Article 84) defining how a manufacturer's post-market surveillance system collects and assesses data — sources, methods, thresholds and responsibilities.

PMS Report (PMSR)

The post-market surveillance summary required for Class I devices under EU MDR Article 85, updated when necessary and held for competent authorities on request. See PSUR vs PMS Report.

PSUR (Periodic Safety Update Report)

The more detailed periodic report required for Class IIa, IIb and III devices under EU MDR Article 86 — adding benefit-risk conclusions, PMCF findings and sales/usage data, on a fixed update cycle with Notified Body review for the highest-risk classes.

Adverse event

An incident where a medical device may have caused or contributed to a death, serious injury or malfunction. Manufacturers have mandatory reporting duties; the reports become public data in databases like FDA MAUDE.

CAPA (Corrective and Preventive Action)

The quality-system process for investigating and eliminating the causes of nonconformities. External signals surfaced by regulatory intelligence are a common CAPA trigger.

Data sources

FDA MAUDE

The FDA's Manufacturer and User Facility Device Experience database — the public repository of US medical device reports covering suspected device-associated deaths, injuries and malfunctions. See how to monitor MAUDE.

openFDA

The FDA's public API programme, giving programmatic access to adverse events, recalls, clearances and the GUDID device registry — the backbone of automated US monitoring.

Field safety notice (FSN)

The communication a manufacturer sends to customers about a field safety corrective action (FSCA) — published by regulators such as the UK's MHRA. A primary early-warning signal outside the US. See monitoring beyond the FDA.

EU Safety Gate

The EU's rapid alert system for dangerous non-food products. Broader than medical devices, but device alerts appear there — often catching consumer-channel and non-compliant products first.

EUDAMED

The EU's central medical-device database under the MDR — actor registration, UDI/device data, certificates, vigilance and market surveillance — rolling out in phases.

UDI / GUDID

Unique Device Identification: the global system for identifying devices through distribution and use. GUDID is the FDA's public UDI database, useful for bulk-importing a device portfolio into monitoring tools.

Grey market & enforcement

Grey-market device

A genuine medical device sold outside the manufacturer's authorised distribution channels — distinct from a counterfeit (a fake). Sources include diverted stock, decommissioned hospital equipment and uncontrolled returns. See the grey-market guide.

Diversion

The movement of product from its intended sales channel into an unauthorized one — e.g., stock bought at a discounted tender price resold at market rates elsewhere.

Shadow recall MedFortis usage

Recalled device units that persist on the open market — resale listings that outlive the recall notice, beyond the reach of the manufacturer's distribution records. The hardest units to retrieve, and a key argument for continuous marketplace monitoring.

Watchlist

The definition of what a monitoring system protects: device models, model families, serial patterns and keywords (including misspellings and multilingual variants) that scans are matched against.

AI vision verification

Using AI image analysis to confirm that a marketplace listing actually shows the watched device — device vs accessory, correct model, visible markings such as an Rx-only label — with a confidence score, so humans only review what needs judgment.

Seller-network mapping

Linking marketplace sellers into networks by shared traits and behaviour, so one confirmed violation exposes a coordinated or repeat seller's whole footprint.

Takedown

The formal request to a marketplace to remove an unauthorized or violating listing, tracked to closure and logged as part of the evidence trail.

Evidence trail / audit-ready

Findings captured at detection time — images, metadata, timestamps — hashed for tamper-evidence and preserved with a write-once action log, meeting the documentation standard of FDA 21 CFR Part 11. The difference between "we monitor" as a claim and as a demonstrable fact.