UK Statutory Instrument SI 2024/1368 United Kingdom

Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024

These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618) (“the 2002 Regulations”) to insert new post-market surveillance requirements. The 2002 Regulations were made under section 2(2) of the European Communities Act 1972 to implement Directives 90/385/EEC, 93/42/EEC and 98/79/EC.

Read it on legislation.gov.uk (opens in a new tab)
Enforced by
MHRA
Status
In Force
Penalty ceiling
Regulated

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer1

Other Acts binding the same actors

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Manufacturer — also bound by 502 other Acts

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

s.004 New Part 4A (post-market surveillance requirements) Regulated
  • Maintain post-market surveillance system and comply with reporting dutiesManufacturer
5 other provisions — procedural and definitional
s.001 Citation, commencement, extent and application
s.002 Amendments to the Medical Devices Regulations 2002
s.003 Amendment to regulation 2 (interpretation)
s.005 Amendment to Schedule 2A
s.006 Saving provision

Help complying

Guvnor’s practical routes through this instrument.

Placing a medical device on the GB market

End-to-end learning path for manufacturers bringing a medical device to the Great Britain market for the first time. Covers pre-market steps (classification, …

Medical device compliance quick check

Quick compliance verification for experienced medical device manufacturers. Check your device classification, registration status, marking validity, PMS system, and vigilance reporting readiness.

Selling medical devices in both GB and Northern Ireland

How to achieve dual-market access for medical devices across Great Britain and Northern Ireland. Covers the different regulatory frameworks, marking options, conformity …

Responding to a medical device safety incident

Immediate actions when a serious incident occurs involving your medical device. Covers incident identification, reporting timeline determination, MORE portal submission, investigation requirements, …

Post-market surveillance for medical devices

How to establish and maintain a post-market surveillance system for medical devices on the GB market under the enhanced requirements in force …

Report a medical device safety incident to MHRA

Step-by-step guide to reporting serious medical device incidents to MHRA via the MORE portal. Covers incident identification, timeline classification (2, 10, or …
1 more guide that reference this instrument
Medical device compliance checklist

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.