🇬🇧United Kingdom Medical Device Regulations

Medical Devices (Post-market Surveillance) Amendment Regulations 2024

Clarifies and strengthens post-market surveillance requirements for medical devices in Great Britain. Effective June 16, 2025.

Implementation of Future Medical Device Regulations

Planned new UK medical device legislation introducing international reliance pathways and enhanced pre-market requirements. Statutory instruments expected 2025-2026.

Medical Devices Regulations 2002 - Consolidated Version

Consolidated version of UK MDR 2002 showing all amendments in a single document. CE marking accepted until June 30, 2030 under transitional arrangements.

Guidance on Software as a Medical Device

MHRA guidance on standalone software qualifying as medical devices. Covers classification, clinical evidence, and AI/ML considerations.

Register Medical Devices to Place on the UK Market

Requirements for registering medical devices with MHRA. All devices must be registered before placing on GB market. Non-UK manufacturers must appoint a UK Responsible Person.

UKCA Marking for Medical Devices

Requirements for UKCA marking on medical devices for Great Britain market. CE marking accepted under transitional provisions until June 30, 2030.

UK Approved Bodies for Medical Devices

List and requirements for UK Approved Bodies that conduct conformity assessments for medical devices. Equivalent to EU Notified Bodies for UKCA marking.

Clinical Investigations of Medical Devices

Requirements for conducting clinical investigations of medical devices in the UK. Covers ethical approval, notification, and reporting requirements.

The Medical Devices Regulations 2002

Primary UK regulation for medical devices implementing EU Directives. Covers general medical devices (Part II), active implantable devices (Part III), and IVDs (Part IV). Amended multiple times since Brexit.