Essential Requirements — overview
The Essential Requirements under the UK Medical Devices Regulations 2002 — what they are, where they are found (Schedule 1 and Schedule 1A), how to demonstrate conformity, the role of UK-designated standards, and the checklist and traceability matrix approach.
General requirements — ER 1–6
A detailed examination of the six general Essential Requirements in Section I of Schedule 1 of the UK Medical Devices Regulations 2002 — the safety, performance, risk management, and design principles that apply to every medical device placed on the GB market.
Design & construction requirements — ER 7–17
The specific design and construction Essential Requirements in Section II of Schedule 1 of the UK Medical Devices Regulations 2002 — covering chemical and biological properties, infection control, measuring function, radiation, software, and labelling.
IVD Essential Requirements (Schedule 1A)
The Essential Requirements specific to in vitro diagnostic medical devices under Schedule 1A of Part III of the UK Medical Devices Regulations 2002 — analytical performance, clinical performance, labelling, and instructions for use requirements.
Checklist & compliance matrix
How to structure an Essential Requirements checklist and traceability matrix for a UK MDR 2002 technical file — with a worked example framework, common pitfalls, and guidance on maintaining the checklist throughout the device lifecycle.