Schedule 1 — Essential Requirements
This page covers official UK legislation. Always verify against the current consolidated text at legislation.gov.uk.
This site provides general information only and does not constitute legal or regulatory advice.
Overview
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 1 structure
Schedule 1 is divided into two sections:
Section I — General requirements (ERs 1–6): Apply to all devices regardless of type. Cover safety, risk-benefit balance, performance, durability, transport/storage, and acceptable side effects. See General requirements — ER 1–6.
Section II — Requirements for specific device types (ERs 7–18): Additional requirements for devices with particular characteristics. Cover biocompatibility (ER 7), sterilisation and infection control (ER 8), measuring function (ER 9), energy sources (ER 10–13), software (ER 14), AIMDs (ER 15), devices incorporating substances (ER 16–17), and labelling/IFU (ER 18).
See Essential Requirements overview and Design and construction requirements for detailed guidance.
Schedule 1A — IVD Essential Requirements
Schedule 1A (Part III) contains Essential Requirements specific to IVD medical devices, covering analytical and clinical performance, design, calibration traceability, and IFU requirements. See IVD Essential Requirements.
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Schedule 1 | Full text — ERs for general devices |
| UK MDR 2002, Part III, Schedule 1A | ERs for IVDs |