MHRA Updates List of UK Approved Bodies for Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance “Medical devices: list of UK approved bodies”, last updated on 15 July 2026.
The guidance provides details of the organisations currently approved to undertake conformity assessments for medical devices under the Medical Devices Regulations 2002 (UK MDR 2002).
Purpose of the List
UK approved bodies are responsible for carrying out conformity assessment activities for medical devices where required under the UK MDR 2002.
The MHRA guidance provides access to the approved scope documents for each organisation, allowing manufacturers to review which device areas and assessment activities each approved body is authorised to cover.
Organisations Listed
The updated MHRA page includes scope documents for several UK approved bodies, covering medical devices, active implantable medical devices and in vitro diagnostic medical devices.
The organisations listed include:
BSI Assurance UK Ltd;
DEKRA Certification UK Ltd;
Eurofins E&E CML Limited;
Scarlet NB UK Ltd;
SGS United Kingdom Limited;
TÜV Rheinland UK Limited;
TÜV SÜD BABT Unlimited;
UL International UK Ltd;
Intertek Medical Notified Body UK Ltd.
The page includes separate scope documents for different device areas, including medical devices, in vitro diagnostic medical devices and active implantable medical devices where applicable.
Relevance for Conformity Assessment
For manufacturers seeking UKCA marking or maintaining compliance in the UK market, the list is an important reference point for identifying suitable UK approved bodies.
Manufacturers should review the relevant scope documents carefully to confirm whether an approved body is authorised for the applicable device type, technology area and conformity assessment route.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers placing products on the UK market, the updated MHRA list reinforces the importance of checking approved body availability and scope before planning conformity assessment activities.
Manufacturers should pay particular attention to:
whether the selected UK approved body is listed by MHRA;
the specific scope of designation for the relevant device type;
differences between medical device, IVD and active implantable device scopes;
UKCA certification planning;
timelines for conformity assessment;
alignment with UK MDR 2002 requirements;
impact on market access and regulatory strategy.
For manufacturers with products already certified or under review, the updated list may also be relevant when confirming approved body status, planning renewals or assessing future UK regulatory pathways.
