UK-designated standards
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
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.
What are UK-designated standards?
UK-designated standards are published standards (British Standards, ISO standards, IEC standards, and others) that have been designated by MHRA/BSI as providing a presumption of conformity with the Essential Requirements to which they relate. This is the UK equivalent of harmonised standards in the EU.
When a manufacturer applies a UK-designated standard in full, they benefit from a presumption that the device meets the relevant Essential Requirements — they do not need to demonstrate conformity through other means for those requirements.
Key UK-designated standards
| Standard | Scope | Essential Requirements addressed |
|---|---|---|
| ISO 13485:2016 | Quality management systems for medical devices | Design controls, manufacturing quality |
| ISO 14971:2019 | Risk management for medical devices | ER 2 (risk minimisation) |
| IEC 60601-1 | Electrical safety of active medical devices | ERs 10–13 (electrical safety, EMC) |
| IEC 60601-1-2 | EMC for medical devices | ER 13 (EMC) |
| IEC 62304:2006+AMD1 | Software lifecycle processes | ER 14 (software) |
| IEC 62366-1:2015 | Usability engineering | ER 1, 2 (safety related to use) |
| ISO 10993-1:2018 | Biological evaluation — risk-based framework | ER 7 (biocompatibility) |
| ISO 11135:2014 | EO sterilisation | ER 8 (sterility) |
| ISO 11137 series | Radiation sterilisation | ER 8 (sterility) |
| ISO 11607 series | Sterile barrier packaging | ERs 5, 8 (packaging, sterility) |
| ISO 15223-1 | Symbols for medical device labelling | ER 18 (labelling) |
Where to find the current list
MHRA publishes the current list of UK-designated standards at: gov.uk/government/publications/designated-standards-for-medical-devices
Not all EU harmonised standards are automatically UK-designated. Check MHRA's current list — do not assume EU harmonised status equals UK-designated status.
Official references
| Reference | Description |
|---|---|
| MHRA: Designated standards for medical devices | Current list of UK-designated standards |
| BSI | British Standards Institution — UK standards body |