What is a medical device?
The legal definition of a medical device under the UK Medical Devices Regulations 2002 (SI 2002/618), the intended purpose principle, mode of action exclusion, and how to determine whether your product requires MHRA compliance.
What is an IVD?
The legal definition of an in vitro diagnostic medical device (IVD) under Part III of the UK Medical Devices Regulations 2002, IVD classification categories, and how IVD regulation differs from general medical devices.
What is not a medical device?
Products that are not medical devices under the UK Medical Devices Regulations 2002 — exclusions, borderline categories, lifestyle and wellness products, and how MHRA approaches products on the boundary of the definition.
Regulatory framework overview
A structured overview of the UK medical device regulatory framework — the MHRA, the UK MDR 2002, UKCA marking, UK Approved Bodies, the Northern Ireland dual-market position, and how the framework compares to the EU MDR/IVDR.
Great Britain vs Northern Ireland
How the UK's exit from the EU created two distinct medical device regulatory regimes within the United Kingdom — UK MDR 2002 and UKCA marking for Great Britain, and EU MDR/IVDR and CE marking for Northern Ireland under the Windsor Framework.
Who needs to comply?
The economic operators with obligations under the UK Medical Devices Regulations 2002 — manufacturers, UK Responsible Persons (UKRPs), importers, distributors, and authorised representatives — and what each role requires.
Lifecycle of a medical device in the UK
A stage-by-stage overview of the regulatory lifecycle of a medical device in Great Britain — from concept and classification through pre-market conformity assessment and MHRA registration to post-market surveillance, vigilance, and end-of-life obligations under the UK MDR 2002.
Post-Brexit transition timeline
A chronological overview of the key regulatory transitions affecting medical device manufacturers operating in the UK market since Brexit — UKCA implementation, CE marking grace periods, MHRA registration deadlines, and the Northern Ireland Windsor Framework.
Glossary of key terms
Plain English definitions of the key regulatory terms used in the UK Medical Devices Regulations 2002 and MHRA guidance — from AIMD and Declaration of Conformity to UKCA marking, UKRP, and vigilance reporting.