Regulatory topic

UK medical device registration, explained and searchable

Since Brexit, medical devices placed on the Great Britain market must be registered with the MHRA, and manufacturers based outside the UK must appoint a UK Responsible Person. MedTech Signal imports the MHRA's public registration database and device safety alerts, and lines them up with US, Canadian and EU records.

Who has to register

Manufacturers of general medical devices, IVDs and custom-made devices must register with the MHRA before placing them on the Great Britain market. Manufacturers outside the UK register through a UK Responsible Person, who is named on the public record.

UKCA and CE marking

Great Britain accepts both UKCA and CE marked devices for a transition period that the UK government has extended several times. Northern Ireland follows EU rules. Check current MHRA guidance for the dates that apply to your device class.

Safety alerts

The MHRA publishes field safety notices, device safety information and national patient safety alerts on GOV.UK. MedTech Signal holds that history, searchable by title and summary, with a link to each notice.

The four-market view

For each UK manufacturer, MedTech Signal shows whether a company with the same cleaned name appears in FDA, Health Canada or EUDAMED records, labelled as a match, a possible match or no apparent match. Reviewers can claim and confirm links privately.

Sources: the MHRA Public Access Registration Database (PARD) and GOV.UK device safety alerts, refreshed on a schedule. Device lists load manufacturer by manufacturer over several days. A missing UK record is never read as "not registered".

MedTech Signal organizes published regulator records for information only. Confirm anything you rely on against the linked regulator record.