Regulatory Links

Regulatory Links were found to be accurate on Jan 2022. If you find a broken Link or have suggestions for new Link, let us know.

Regulatory Organizations

Medical Device Adverse Incident Databases

While accessing device risk, or while determining the appropriateness of existing safety requirements, it can be useful to consider adverse incidents for similar products. The following links can be used to review reported adverse incidents.

US FDA - Manufacturer and User Facility Device Experience (MAUDE) Database

UK - MHRA Adverse Incident Reports

EUDAMED - European Database on Medical Devices (21 Jan 2022, doesn't appear to be searchable?)