NIAIC
Device Regulations
The Medicines and Healthcare Products Regulatory Agency (MHRA) is the
UK Competent Authority under the European medical devices Directives and has responsibility for:
- Implementing the Directives and ensuring that products on the UK market are safe
- Ensuring that the UK Regulations are enforced and that the market monitored to check compliance
- Assessing applications from manufacturers for clinical investigations of new devices
- Designating and monitoring Notified Bodies
The
MHRA published a series of Directives Bulletins and Guidance Notes to give advice and information for
medical device manufactures and users of medical devices. The text of MHRA Directives Bulletins and
Guidance Notes are available on the MHRA Internet Site at www.mhra.gov.uk
For guidance about individual publications please contact:
Northern Ireland Adverse Incident Centre (NIAIC)
Room A7
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast BT16 1US
Room A7
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast BT16 1US
