Medical devices: how to comply with legal requirements in Great Britain
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What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
Adapted edition
- Document type
- Reference Guide
- Format
- DOCX
- Pages
- 6
- Language
- English
- Version
- 1.0
- Updated
- 2026-09-16
- Category
- Safety & operations
- Licence
- Open Government Licence v3.0
Description
What you need to do before your product can be placed on the Great Britain market with a UKCA mark. Consult the original guidance for current legal and operational details.
Contents
- Overview
- Definition of a medical device
- Medical device types and their associated Part
- Active implantable medical devices
- In vitro diagnostic devices
- General medical devices
- Complying with the legal requirements
- Classification of medical devices
- General medical devices and active implantable devices
- In vitro diagnostic medical devices (IVDs)
- Conformity assessment and UKCA marking
- Assessment route for general medical devices and active implantable devices
- Assessment route for IVDs
- Clinical data and clinical investigations
- Post-market monitoring and surveillance
Source and licence
Medicines and Healthcare products Regulatory Agency
AttributionMedicines and Healthcare products Regulatory Agency, ‘Medical devices: how to comply with legal requirements in Great Britain’ (updated 15 January 2025), reused under the Open Government Licence v3.0.
ChangesNeutral text-only adaptation from the official GOV.UK Content API body: headings, paragraphs, ordered and unordered list items and clickable source-link destinations in an appendix preserved. Images, logos, page design, accessible-format request widgets and linked attachments excluded; normalised whitespace, invisible format marks and typography.
Version history
- v1.016/09/2026