UK Notified Bodies under the Medical Devices Directives

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This page includes details of the UK Notified Bodies listed under the various Medical Devices Directives.

Amtac Certification Services Ltd (0473)
Davy Avenue Knowlhill Milton Keynes MK5 8NL	Contact : Mr Ron Nash Tel : 01908 857750 Fax : 01908 857751	Medical Devices Directive 93/42/EEC including 2003/32/EC Product range under Annexes II, V and VI: All Medical Devices - including medical devices utilising tissue or derivatives originating from animals In Vitro Diagnostic Medical Devices Directive 98/79/EEC Product range under Annex III : Own Brand labelling of all self-test devices which have existing NB certification via their original manufacturer. Product range under Annexes IV, V, VI and VII : Own Brand Labelling of all Annex II List A devices which have existing NB certification via their original manufacturer. Own Brand Labelling of all Annex II List B devices which have existing NB certification via their original manufacturer. Own Brand Labelling of all self-test devices which have existing NB certification via their original manufacturer.

BSI Healthcare (0086)
Medical Devices Certification BSI Healthcare Kitemark Court Davy Avenue Milton Keynes MK5 8PP	Contact : Mr John Howlett Tel : 0845 080 9000	Medical Devices Directive 93/42/EEC including 2000/70/EC and 2003/32/EC Product range under Annexes II, III and V: All Medical Devices - including medical devices incorporating human blood derivatives - including medical devices utilising tissue or derivatives originating from animals Product range under Annexes IV and VI: All Medical Devices Active Implantable Medical Device Directive 90/385/EC Product range under Annexes II, III and V : All active implantable medical devices In Vitro Diagnostic Medical Devices Directive 98/79/EC Product Range Under Annex IV, V & VII IVDs on List A IVD 0101 ABO System IVD 0102 Rhesus (C, c, D, E, e) IVD 0103 Anti-Kell IVD 0201 HIV infection (HIV 1 and 2) IVD 0202 HTLV I and II IVD 0203 Hepatitis B, C and D Product Range under Annex IV, V & VII IVDs on List B IVD 0301 Anti-Duffy and anti-Kidd IVD 0302 Irregular anti-erythrocytic antibodies IVD 0303 Congenital infections: rubella, toxoplasmosis IVD 0304 Hereditary disease: phenylketonuria IVD 0305 Human infections: cytomegalovirus, chlamydia IVD 0306 HLA tissue groups: DR, A, B IVD 0307 Tumoral marker: PSA IVD 0308 Risk of trisomy 21 (incl. software) IVD 0309 Device for self-diagnosis: device for the measurement of blood sugar Product Range under Annex III, IV, V, VI, VII IVDs for self-test (excluding those in Annex II) IVD 0401 Clinical chemistry IVD 0402 Haematology IVD 0403 Immunology IVD 0405 Pregnancy and ovulation IVD 0406 Specimen receptacles IVD Specifics MDS 7206 IVDs in sterile condition MDS 7208 IVDs utilising nanomaterials MDS 7209 IVDs utilising biological active coating and/or material MDS 7210 IVDs utilising material of human origin

BSI Healthcare (0086)

Medical Devices Certification
BSI Healthcare
Kitemark Court
Davy Avenue

Milton Keynes

MK5 8PP

Contact : Mr John Howlett

Tel : 0845 080 9000

Medical Devices Directive 93/42/EEC including 2000/70/EC and 2003/32/EC
Product range under Annexes II, III and V:
All Medical Devices
- including medical devices incorporating human blood derivatives
- including medical devices utilising tissue or derivatives originating from animals
Product range under Annexes IV and VI:
All Medical Devices
Active Implantable Medical Device Directive 90/385/EC
Product range under Annexes II, III and V :
All active implantable medical devices

In Vitro Diagnostic Medical Devices Directive 98/79/EC
Product Range Under Annex IV, V & VII
IVDs on List A
IVD 0101 ABO System
IVD 0102 Rhesus (C, c, D, E, e)
IVD 0103 Anti-Kell IVD 0201 HIV infection (HIV 1 and 2)
IVD 0202 HTLV I and II
IVD 0203 Hepatitis B, C and D

Product Range under Annex IV, V & VII
IVDs on List B
IVD 0301 Anti-Duffy and anti-Kidd
IVD 0302 Irregular anti-erythrocytic antibodies
IVD 0303 Congenital infections: rubella, toxoplasmosis
IVD 0304 Hereditary disease: phenylketonuria
IVD 0305 Human infections: cytomegalovirus, chlamydia
IVD 0306 HLA tissue groups: DR, A, B IVD 0307 Tumoral marker: PSA
IVD 0308 Risk of trisomy 21 (incl. software)
IVD 0309 Device for self-diagnosis: device for the measurement of blood sugar

Product Range under Annex III, IV, V, VI, VII
IVDs for self-test (excluding those in Annex II)
IVD 0401 Clinical chemistry
IVD 0402 Haematology
IVD 0403 Immunology
IVD 0405 Pregnancy and ovulation
IVD 0406 Specimen receptacles

IVD Specifics
MDS 7206 IVDs in sterile condition
MDS 7208 IVDs utilising nanomaterials
MDS 7209 IVDs utilising biological active coating and/or material
MDS 7210 IVDs utilising material of human origin

Intertek Testing and Certification Ltd (0359)
Intertek Testing & Certification Ltd Intertek House Cleeve Road Leatherhead Surrey KT22 7SB	Contact : Mr Geoff Hines Tel : 01372 370900 Fax : 01372 370999	Medical Devices Directive 93/42/EEC Product range under Annexes IV: Active Medical Devices but excluding Extracorporeal Blood Treatment Equipment Blood Gas Analysers Anaesthesia Machines Lung Ventilators Respiratory Therapy Equipment Breathing Systems Attachments and Components Electrosurgical Equipment Lasers Defibrillators Radiotherapy Radionuclide and Magnetic Resonance Imaging

Lloyd's Register Quality Assurance Ltd (0088)
LRQA Ltd LRQA Centre Hiramford Middlemarch Office Village Siskin Drive Coventry CV3 4FJ	Contact : Mr John Andrews Technical and Operations Manager EC Directives Unit Tel : 024 7688 2373 Fax : 024 7630 6055 Email : ecdirectives@lrqa.com john.andrews@lrqa.com	Medical Devices Directive 93/42/EEC including 2003/32/EC Product range under Annexes II, V and VI: All Medical Devices - including medical devices utilising tissue or derivatives originating from animals In Vitro Diagnostic Medical Devices Directive 98/79/EC Product range under Annex III Self Test Devices for urinalysis, endocrinology, general chemistry, general immunology and haematology. All self-test devices which have existing notified body certification via their original manufacturer. Product range under Annexes IV and VII All Annex II devices. Self Test Devices for urinalysis, endocrinology, general chemistry, general immunology and haematology. All Annex II devices which have existing notified body certification via their original manufacturer. All self-test devices which have existing notified body certification via their original manufacturer.

SGS United Kingdom Ltd (0120)
Unit 202b Worle Parkway Weston-Super-Mare North Somerset BS22 0WA	Contact : Chris Jepson Tel : 01934 522917 Fax : 01934 522137 Email : sgsprodcert@sgs.com	Medical Devices Directive 93/42/EEC including 2003/32/EC Product range under Annexes II, V and VI All Medical Devices - including medical devices utilising tissue or derivatives originating from animals Product range under Annex III Condoms (with and without spermicide) Defibrillators (external) Dialysis Equipment ECG Monitors Infusion Pumps Product range under Annex IV Condoms (with and without spermicide) Clinical Thermometers Active Medical Devices (Class I (measuring) and IIa which require compliance with EN 6060101 and measurements of voltage, current, temperature, pressure, weight and time) In Vitro Diagnostic Medical Devices Directive 98/79/EC Product range under Annex IV and VII IVDs on List A IVD 0101 - ABO Systems IVD 0102 - Rhesus (C, c, D, E, e) IVD 0103 - Anti-Kell IVD 0201 - HIV Infection (HIV 1 and 2) IVD 0202 - HTLV I and II IVD 0203 - Hepatitis B, C and D IVDs on List B IVD 0301 - Anti-Duffy and Anti-Kidd IVD 0302 - Irregular anti-erythrocytic antibodies IVD 0303 - Congenital infections: rubella, toxoplasmosis IVD 0304 - Hereditary disease: phenylketonuria IVD 0305 - Human infections: cytomegalovirus, chlamydia IVD 0306 - HLA tissue groups: DR, A, B IVD 0307 - Tumoral marker : PSA IVD 0308 - Risk of trisomy 21 (inc. software) IVD 0309 - Devices for self-diagnosis: device for the measurement of blood sugar Product range under Annex III, IV and VII IVDs for self-test IVD 0401 - Clinical chemistry IVD 0402 - Haematology IVD 0403 - Immunology IVD 0405 - Pregnancy and ovulation IVD 0406 - Specimen receptacles IVD Specifics MDS 7206 - IVDs in sterile condition MDS 7207 - IVDs utilising micromechanics MDS 7208 - IVDs utilising nanomaterials MDS 7209 - IVDs utilising biological active coating and/or material MDS 7210 - IVDs utilising material of human origin

SGS United Kingdom Ltd (0120)

Unit 202b
Worle Parkway
Weston-Super-Mare
North Somerset
BS22 0WA

Contact : Chris Jepson

Tel : 01934 522917
Fax : 01934 522137
Email : sgsprodcert@sgs.com

Medical Devices Directive 93/42/EEC including 2003/32/EC
Product range under Annexes II, V and VI
All Medical Devices
- including medical devices utilising tissue or derivatives originating from animals
Product range under Annex III
Condoms (with and without spermicide)
Defibrillators (external)
Dialysis Equipment
ECG Monitors
Infusion Pumps
Product range under Annex IV
Condoms (with and without spermicide)
Clinical Thermometers
Active Medical Devices (Class I (measuring) and IIa which require compliance with EN 6060101 and measurements of voltage, current, temperature, pressure, weight and time)

In Vitro Diagnostic Medical Devices Directive 98/79/EC
Product range under Annex IV and VII

IVDs on List A
IVD 0101 - ABO Systems
IVD 0102 - Rhesus (C, c, D, E, e)
IVD 0103 - Anti-Kell IVD 0201 - HIV Infection (HIV 1 and 2)
IVD 0202 - HTLV I and II
IVD 0203 - Hepatitis B, C and D

IVDs on List B
IVD 0301 - Anti-Duffy and Anti-Kidd
IVD 0302 - Irregular anti-erythrocytic antibodies
IVD 0303 - Congenital infections: rubella, toxoplasmosis
IVD 0304 - Hereditary disease: phenylketonuria
IVD 0305 - Human infections: cytomegalovirus, chlamydia
IVD 0306 - HLA tissue groups: DR, A, B
IVD 0307 - Tumoral marker : PSA
IVD 0308 - Risk of trisomy 21 (inc. software)
IVD 0309 - Devices for self-diagnosis: device for the measurement of blood sugar

Product range under Annex III, IV and VII
IVDs for self-test
IVD 0401 - Clinical chemistry
IVD 0402 - Haematology
IVD 0403 - Immunology
IVD 0405 - Pregnancy and ovulation
IVD 0406 - Specimen receptacles

IVD Specifics
MDS 7206 - IVDs in sterile condition
MDS 7207 - IVDs utilising micromechanics
MDS 7208 - IVDs utilising nanomaterials
MDS 7209 - IVDs utilising biological active coating and/or material
MDS 7210 - IVDs utilising material of human origin

UL International (UK) Ltd (0843)
UL International (UK) Ltd Wonersh House The Guildway Old Portsmouth Road Guildford Surrey GU3 1LR	Tel : 01483 302130 Fax : 01483 302230 Email : Inform.NB@uk.ul.com Web: www.ul-europe.com/CE_Mark	Medical Devices Directive 93/42/EEC Product range under Annexes II, V and VI All Active Medical Devices including accessories Disinfectants and Surgical Instruments Sterile Single Use Medical Devices Wound Dressings falling into Class IIa or IIb. Class III Cardiac catheters excluding Other Class III devices Ophthalmic devices (Class IIa and above) Implants Own Brand Labelling of all medical devices which have existing NB certification via their original manufacturer. All Dental Devices (non active) Product range under Annex III All Active Medical Devices including accessories Wound Dressings falling into Class IIa or IIb. Own Brand Labelling of all medical devices which have existing NB certification via their original manufacturer. Product range under Annex IV All Active Medical Devices including accessories Gloves Urinary catheters Wound Dressings falling into Class IIa or IIb. Own Brand Labelling of all medical devices which have existing NB certification via their original manufacturer. In Vitro Diagnostic Medical Devices Directive 98/79/EC Product range under Annex III Self diagnosis devices for determining pregnancy and ovulation, cholesterol, diabetes management, urine analysis, coagulation, endocrinology, general biochemistry, and general immunology. Own brand labelling of all self-test devices which have existing NB certification via their original manufacturer, Product range under Annex IV Devices for the determination of Toxoplasmosis, Rubella, Cytomegalovirus, and Chlamydia All List A devices Anti-Duffy, anti-Kidd, irregular anti-erythrocytic antibodies, Devices for determination of PSA (List B). Self diagnosis devices for the measurement of blood sugar,determining pregnancy and ovulation, cholesterol, diabetes diagnosis and management, urine analysis, coagulation, endocrinology, general biochemistry and chemistry, general immunology and determination of chlamydia infection and PSA. Devices for diagnosing phenylketoneuria, determining HLA tissue groups: DR, A, B and evaluating risk of trisomy 21. Own brand labelling of all Annex II and all self-test devices which have existing NB certification via their original manufacturer. Product range under Annex V Devices for the determination of Toxoplasmosis, Rubella, Cytomegalovirus, and Chlamydia All List A devices. Anti-Duffy, anti-Kidd, irregular anti-erythrocytic antibodies (List B). Own brand labelling of all Annex II and all self-test devices which have existing NB certification via their original manufacturer. Product range under Annex VI Devices for the determination of Toxoplasmosis, Rubella, Cytomegalovirus, and Chlamydia Anti-Duffy, anti-Kidd, irregular anti-erythrocytic antibodies (List B) Own brand labelling of all Annex II List B and all self-test devices which have existing NB certification via their original manufacturer. Product range under Annex VII Devices for the determination of Toxoplasmosis, Rubella, Cytomegalovirus, and Chlamydia All List A devices. Anti-Duffy, anti-Kidd, irregular anti-erythrocytic antibodies (List B). Devices for diagnosing phenylketoneuria, determining HLA tissue group: DR, A, B and evaluating trisomy 21. Own brand labelling of all Annex II and all self-test devices which have existing NB certification via their original manufacturer.

UL International (UK) Ltd (0843)

UL International (UK) Ltd
Wonersh House
The Guildway
Old Portsmouth Road
Guildford
Surrey
GU3 1LR

Tel : 01483 302130
Fax : 01483 302230
Email : Inform.NB@uk.ul.com
Web: www.ul-europe.com/CE_Mark

Medical Devices Directive 93/42/EEC
Product range under Annexes II, V and VI
All Active Medical Devices including accessories
Disinfectants and Surgical Instruments
Sterile Single Use Medical Devices
Wound Dressings falling into Class IIa or IIb.
Class III Cardiac catheters
excluding

Other Class III devices
Ophthalmic devices (Class IIa and above)
Implants

Own Brand Labelling of all medical devices which have existing NB certification via their original manufacturer.
All Dental Devices (non active)

Product range under Annex III
All Active Medical Devices including accessories
Wound Dressings falling into Class IIa or IIb.
Own Brand Labelling of all medical devices which have existing NB certification via their original manufacturer.

Product range under Annex IV
All Active Medical Devices including accessories
Gloves
Urinary catheters
Wound Dressings falling into Class IIa or IIb.
Own Brand Labelling of all medical devices which have existing NB certification via their original manufacturer.

In Vitro Diagnostic Medical Devices Directive 98/79/EC
Product range under Annex III
Self diagnosis devices for determining pregnancy and ovulation, cholesterol, diabetes management, urine analysis, coagulation, endocrinology, general biochemistry, and general immunology.
Own brand labelling of all self-test devices which have existing NB certification via their original manufacturer,

Product range under Annex IV
Devices for the determination of Toxoplasmosis, Rubella, Cytomegalovirus, and Chlamydia
All List A devices
Anti-Duffy, anti-Kidd, irregular anti-erythrocytic antibodies, Devices for determination of PSA (List B).
Self diagnosis devices for the measurement of blood sugar,determining pregnancy and ovulation, cholesterol, diabetes diagnosis and management, urine analysis, coagulation, endocrinology, general biochemistry and chemistry, general immunology and determination of chlamydia infection and PSA.
Devices for diagnosing phenylketoneuria, determining HLA tissue groups: DR, A, B and evaluating risk of trisomy 21.
Own brand labelling of all Annex II and all self-test devices which have existing NB certification via their original manufacturer.

Product range under Annex V
Devices for the determination of Toxoplasmosis, Rubella, Cytomegalovirus, and Chlamydia
All List A devices.
Anti-Duffy, anti-Kidd, irregular anti-erythrocytic antibodies (List B).
Own brand labelling of all Annex II and all self-test devices which have existing NB certification via their original manufacturer.

Product range under Annex VI
Devices for the determination of Toxoplasmosis, Rubella, Cytomegalovirus, and Chlamydia
Anti-Duffy, anti-Kidd, irregular anti-erythrocytic antibodies (List B)
Own brand labelling of all Annex II List B and all self-test devices which have existing NB certification via their original manufacturer.

Product range under Annex VII
Devices for the determination of Toxoplasmosis, Rubella, Cytomegalovirus, and Chlamydia
All List A devices.
Anti-Duffy, anti-Kidd, irregular anti-erythrocytic antibodies (List B).
Devices for diagnosing phenylketoneuria, determining HLA tissue group: DR, A, B and evaluating trisomy 21.
Own brand labelling of all Annex II and all self-test devices which have existing NB certification via their original manufacturer.

Page last modified: 08 July 2011