UK MDR 2002 — overview & structure
Overview of the UK Medical Devices Regulations 2002 (SI 2002/618 as amended) — its three Parts, key provisions, post-Brexit amendments, and how it fits within the wider UK regulatory framework for medical devices.
How to read UK legislation
A practical guide to navigating legislation.gov.uk to find, read, and interpret the UK MDR 2002 and its amendments — including the difference between the original and revised (consolidated) text.
Post-Brexit amending instruments
The statutory instruments that have amended the UK MDR 2002 since Brexit — principally SI 2019/791 and subsequent instruments extending transitional arrangements and introducing regulatory changes.
Schedule 1 — Essential Requirements
Schedule 1 of the UK MDR 2002 contains the Essential Requirements for general medical devices and AIMDs. Schedule 1A (Part III) contains the ERs for IVD medical devices.
Schedule 2 — Classification rules
Schedule 2 of the UK MDR 2002 contains the 18 classification rules for general medical devices. These rules are applied by manufacturers to determine whether a device is Class I, IIa, IIb, or III.
Schedule 3 — Conformity assessment
Schedule 3 of the UK MDR 2002 contains the conformity assessment annexes (Annexes I–VII equivalent) for general medical devices. Equivalent provisions for AIMDs are in Part II Schedule 3, and for IVDs in Part III Schedule 3.
UK-designated standards
UK-designated standards for medical devices — the list of standards that provide a presumption of conformity with the Essential Requirements of the UK MDR 2002, including ISO 13485, ISO 14971, and the IEC 60601 series.