Medical Devices (Amendment ) (EU Exit) Regulations 2019
Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
What this means for your business
- Enforced by
- MHRA
- Applies to
- United Kingdom
- On this page
- 6 practical guides
Practical guidance
Our guides explain how to comply with the requirements above.
MHRA authorisation for medicines and medical devices
How to obtain MHRA authorisation for medicines and medical devices in the UK. Covers Marketing Authorisations, wholesale dealer licences, manufacturer …
Medical devices and equipment compliance
Regulatory requirements for medical devices including vigilance reporting and equipment maintenance.
MHRA licensing for medicines and medical devices
MHRA licensing requirements for manufacturing, distributing, and importing medicines and medical devices in the UK.
Placing medical devices on the Northern Ireland market
How to comply with the Northern Ireland medical device regime under the Windsor Framework. Covers EU MDR/IVDR requirements, CE marking, …
UKCA and CE marking for medical devices
How to choose between UKCA and CE marking for your medical device on the GB market. Covers UKCA marking via …
Medical devices: placing on the GB market
How to comply with the UK Medical Devices Regulations 2002 when placing medical devices on the Great Britain market. Covers …
Sections and provisions
12 classified provisions from this legislation.