List of UK approved bodies for medical devices
Updated 23 May 2025
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BSI Assurance UK Ltd (0086)
BSI Assurance UK Ltd
Kitemark Court
Davy Avenue
Milton Keynes
MK5 8PP
Contact: Vishal Thakker
Email:Â Vishal.Thakker@bsigroup.com
Email:Â BSIMedDev.NB0086@bsigroup.com
Tel : 0845 080 9000
Designated scope - types of medical devices for which the approved body is permitted to issue UKCA certification:
- Medical Devices (designation expires on 31 December 2025)
- Under Part II of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
- Active Implantable Medical Devices (designation expires on 31 December 2025)
- Under Part III of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
- In-vitro Diagnostics Medical Devices
- Under Part IV of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
See the Approved Body바카라 사이트™s full designated scope
DEKRA Certification UK Ltd (8505)
DEKRA Certification UK Limited
Stokenchurch House
Oxford Road
Stokenchurch
HP14 3SX
Contact: Danielle Pixton
Email: certification.uk@dekra.com
Designated scope - types of medical devices for which the approved body is permitted to issue UKCA certification:
- Medical Devices (designation expires on 1 September 2027)
- Under Part II of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
- Active Implantable Medical Devices (designation expires on 1st September 2027)
- Under Part III of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
- In Vitro Diagnostic Medical Devices (designation expires on 1st September 2027)
- Under Part IV of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
See the Approved Body바카라 사이트™s full designated scope
Eurofins E&E CML Limited (2503)
Eurofins E&E CML Ltd
Newport Business Park,
New Port Road, Ellesmere Port
CH65 4LZ
United Kingdom
Contact: Cheryl O바카라 사이트™Rourke
Email:Â cheryl.orourke@cpt.eurofinseu.com
Designated scope - types of medical devices for which the approved body is permitted to issue UKCA certification:
- Medical Devices (designation expires on 22nd April 2030)
- Under Part II of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
See the Approved Body바카라 사이트™s full designated scope
INTERTEK MEDICAL NOTIFIED BODY UK Ltd (8532)
Academy Place
1-9 Brook Street
Brentwood
Essex
CM14 5NQ
Contact: Sharmila Gardner
Email: IMNB@intertek.com
Tel : 01277 321234 / 07875 633460
Designated scope 바카라 사이트“ types of medical devices for which the approved body is permitted to issue UKCA certification:
-
Medical Devices (designation expires on 24 August 2028)
-
Under Part II of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
See the Approved Body바카라 사이트™s full designated scope
Scarlet NB UK Ltd (8536)
Scarlet NB UK Ltd
12 New Fetter Lane
London
EC4A 1JP
United Kingdom
Contact: James Dewar
Email: regulatory@scarletcomply.com
Designated scope - types of medical devices for which the approved body is permitted to issue UKCA certification:
- Medical Devices (designation expires on 25th January 2029)
- Under Part II of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
See the Approved Body바카라 사이트™s full designated scope
SGS United Kingdom Ltd (0120)
SGS United Kingdom Limited
Rossmore Business Park
Ellesmere Port
Cheshire
CH65 3EN
Contact: Lynn Henderson
Email: UKCAmedicalAB0120@sgs.com
Tel : +44 (0)121 541 4743
Designated scope - types of medical devices for which the approved body is permitted to issue UKCA certification:
- Medical Devices (designation expires on 16 March 2027)
- Under Part II of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
- In vitro Diagnostic Medical Devices
- Under Part IV of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
See the Approved Body바카라 사이트™s full designated scope
UL International (UK) Ltd (0843)
UL International (UK) Ltd
Unit 1-4 Horizon
Wade Road
Kingsland Business Park
Basingstoke
Hampshire
RG24 8AH
Contact: Paul Daysh
Email: Paul.Daysh@ul.com
Email: inform.regulatory@ul.com
Tel : 01483 302130
Fax : 01483 302230
Designated scope - types of medical devices for which the approved body is permitted to issue UKCA certification:
- In-vitro Diagnostic Medical Devices
- Under Part IV of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
- Medical Devices (designation expires on 21 December 2028)
- Under Part II of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
See the Approved Body바카라 사이트™s full designated scope
TUV Rheinland UK Ltd (2571)
TUV Rheinland UK Ltd
Friars Gate (3rd Floor)
1011 Stratford Road
Shirley
Solihull
B90 4BN
Contact: Justin Morgan
Email: safety@uk.tuv.com
Tel : +44 (0)121 796 9400
Designated scope 바카라 사이트“ types of medical devices for which the approved body is permitted to issue UKCA certification:
- Medical Devices (designation expires on 11 August 2028)
- Under Part II of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
- In-vitro Diagnostic Medical Devices
- Under Part IV of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
See the Approved Body바카라 사이트™s full designated scope
TUV SUD BABT Unlimited (0168)
TUV SUD BABT Unlimited
Octagon House
Concorde Way
Fareham
Hampshire
PO15 5RL
Contact: Monisha Phillips
Email: ukmdr.mhs.info@tuvsud.com
Tel: +44 (0) 1489 558100
Designated scope - types of medical devices for which the approved body is permitted to issue UKCA certification:
- Medical Devices (designation expires on 11th August 2028)
- Under Part II of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
- Active Implantable Medical Devices (designation expires on 11th August 2028)
- Under Part III of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)