9 docs tagged with "fundamentals"

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.

How medical device classification works under the UK Medical Devices Regulations 2002 — the rule-based system for general devices (Classes I, IIa, IIb, III), active implantable devices (AIMD), and IVDs (List A, List B, Self-test, General) — and why classification determines everything else.

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.

An overview of the post-market obligations for medical device manufacturers and economic operators under the UK Medical Devices Regulations 2002 — what continues after a device is placed on the GB market and why post-market compliance is as important as pre-market compliance.

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.

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.

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.

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.

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.