Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.

Browse 6 other sections — procedural / definitional / commencement

s.001

Citation, commencement, extent and application

s.002

Amendments to the Medical Devices Regulations 2002

s.003

Amendment to regulation 2 (interpretation)

s.004

New Part 4A (post-market surveillance requirements)

s.005

Amendment to Schedule 2A

s.006

Saving provision

Official guidance

Authoritative sources published by regulators or government explaining this legislation.

Yellow Card Scheme (for healthcare professionals and patients) (opens in a new tab) Detailed Guidance
MHRA enforcement process for medical devices (opens in a new tab) Publication
Vigilance reporting requirements (opens in a new tab) Publication

Enforcement and responsible bodies

The regulators that administer or enforce this legislation.

MHRA

Medicines and Healthcare products Regulatory Agency

Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.

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

At a glance

Step-by-step journeys using this legislation

Placing a medical device on the GB market

Medical device compliance quick check

Selling medical devices in both GB and Northern Ireland

Responding to a medical device safety incident

Relevant guidance

Direct — cites this Act

Post-market surveillance for medical devices

Report a medical device safety incident to MHRA

Mentioned in related content

What this Act requires