UK approved bodies for medical devices
Updated 14 November 2024
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This publication is available at https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices
BSI Assurance UK Ltd (0086)
BSI Assurance UK Ltd
Kitemark Court
Davy Avenue
Milton Keynes
MK5 8PP
Contact: Vishal Thakker
Email: Vishal.Thakker@bsigroup.com
Email: 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 Body’s full designated scope
DEKRA Certification UK Ltd (8505)
DEKRA Certification UK Limited
Stokenchurch House
Oxford Road
Stokenchurch
HP14 3SX
Contact: Christopher Blue
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)
See the Approved Body’s full designated scope
LNE-GMED UK Limited (8521)
Suite A, First Floor
East Wing Focus 31 Mark Road
Hemel Hempstead
Hertfordshire
HP2 7BW
Contact: Teresa Perry
Email: UKenquiries@lne-gmed.com.
Designated scope – types of medical devices for which the approved body is permitted to issue UKCA certification:
-
Medical Devices (designation expires on 23rd 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)
-
Active Implantable Medical Devices (designation expires on 23rd January 2029)
- 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 23rd January 2029)
- 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 Body’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 Body’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 Body’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 Body’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 – 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 Body’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)
See the Approved Body’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 – 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)