MDAs and NIAIC publications

Medical device alerts

Medical Devices Alerts (MDAs) are the prime means of communicating safety information to HSC organisations and the wider healthcare environment on medical devices. MDA’s are prepared by the MHRA  and are distributed nationally with the same reference, content and format

About MDAs

An MDA may come about as a result investigation by any of the UK administrations where the manufacturer can not demonstrate they have taken appropriate action. Alternatively they can result through other information received by the MHRA from Competent Authorities around the world.

Medical Device Alerts are distributed to the HSC Board, HSC Trusts, and Agencies for direct action and for onward transmission were appropriate in accordance with local procedures. NIAIC arranges for the distribution to Primary Care Professionals.

Anyone accessing this information must bear in mind that this information is directed at health and social care professionals and has been prepared taking into account the specialist knowledge of these intended recipients. Members of the public should contact their GP, health advisor or NIAIC if the content of a notice causes personal concern.

Each alert is sent to HPSS organisations where action is required to be taken. Any member of the public requiring information on a particular notice is advised to contact their General Practitioner or NIAIC directly.

Subtopics

Other Safety Information

Disclaimer

Where documents on this page that have been produced by the MHRA, the UK Competent Authority for Medical Devices, the documents may contain references to legislation and statutory bodies applicable only in England. Northern Ireland readers should be aware that, while the intent of the guidance is applicable in Northern Ireland, they should refer to the appropriate legislation for the region.

NIAIC PUBLICATIONS

Original Reference

Date of Creation or Last Update

Document Name

Link

DB (NI)2010-01

Feb 2015

Managing Medical Devices

 

This document updates and replaces DB(NI)2010/01 and all previous versions.

Managing Medical Devices

 

DB 2006-06

Mar 2020

Bed Rails – Management and Safe Use.

 

This document updates and replaces DB 2006/06 v2 and all previous versions.

Bed rails: management and safe use.
Guidance on managing and using
bed rails safely.

DB 2006-03

Oct 2019

Blood Pressure Measurement Devices

 

This document updates and replaces DB 2006/03 v2 and all previous versions.

Blood pressure measurement devices
Guidance for healthcare professionals
on the use and management of blood
pressure management devices
.

DB 2010-02

Dec 2013

In vitro Diagnostic Point-of-Care Test Devices

 

This document updates and replaces DB 2010/02 and all previous versions.

 

Advice and guidance on the
management and use of point-of-care
testing (POCT) in vitro diagnostic
(IVD) devices.

 

DB 2008/03

Oct 2015

Lasers, intense light source systems and LEDs – guidance for safe use in medical, surgical, dental and aesthetic practices.

 

This document updates and replaces DB 2008/03 and all previous versions.

 

Lasers, intense light source systems
and LEDs – guidance for safe use in
medical, surgical, dental and
aesthetic practices

 

DB 2006/04

Oct 2019

Single-use medical devices: implications and consequences of reuse

 

This document updates and replaces DB 2006/04 and all previous versions.

 


Single-use medical devices: implications
and consequences of reuse

DB 2000-03

Dec 2013

Blood pressure measurement devices

 

This document updates and replaces DB 2000-03 and all previous versions.

 

Guidance for healthcare professionals on the use and management of blood pressure management devices.

 

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