Guidance

UK approved bodies for medical devices

Updated 2 July 2024

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)

See the Approved Body’s full designated scope