UK Notified Bodies under the Medical Devices Directives

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 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

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

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.