Langemarckstraße 20
45141 ESSEN
Country : Germany
Phone : +49 (0) 201 825-3335
Fax : +49 (0) 201 825-3290
Email : info@tuev-nord.de
Notified Body number : 0044
Website : TÜV NORD CERT GmbH

Medical Device Accreditation
MD 0101: Non-active devices for anesthesis, emergency and intensive care
MD 0102: Non-active devices for injection, infusion, transfusion and dialysis
MD 0103: Non-active orthopedic and rehabilitation devices
MD 0104: Non-active Devices with measuring function
MD 0105: Non-active ophthalmologic devices
MD 0106: Non-active instruments
MD 0107: Contraceptive medical devices
MD 0108: Non-active medical devices for disinfecting, cleaning, rinsing
MD 0109: Non-active devices for in vitro fertilsation and assisted reproductive technologies
MD 0201: Non-active cardiovascular implants
MD 0202: Non-active orthopedic implants
MD 0203: Non-active functional implants
MD 0204: Non-active soft tissue implants
MD 0301: Bandages and wound dressings
MD 0302: Suture material and clamps
MD 0303: Other material for wound care
MD 0401: Non-active dental equipment and instruments
MD 0402: Dental Materials
MD 0403: Dental Implants
MD 1101: Devices for exracorporeal circulation, infusion and hemopheresis
MD 1102: Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anesthesia
MD 1103: Devices for stimulation or inhibition
MD 1104: Active surgical devices
MD 1105: Active ophthalmologic devices
MD 1106: Active dental devices
MD 1107: Active devices for disinfection and sterilisation
MD 1108: Active rehabilitation Devices and active prostheses
MD 1109: Active devices for patient positioning and transport
MD 1111: Software
MD 1201: Imaging devices utilising ionizing radiation
MD 1202: Imaging devices utilising non-ionizing radiation
MD 1301: Monitoring devices of non-vital physiological parameters
MD 1302: Monitoring devices of vital physiological parameters
MD 1401: Devices utilising ionizing radiation
MD 1402: Devices utilising non-ionizing radiation

Horizontal Technical Competence
MDS 7001: Medical devices incorporating medicinal substances
MDS 7002: Medical devices utilising tissues of animal origin
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
MDS 7006: Medical devices in sterile condition
MDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

ANNEX II: Full Quality Assurance
ANNEX III: EC-Type Examination
ANNEX IV: EC Verification
ANNEX V: Production Quality Assurance
ANNEX VI: Product Quality Assurance

Active Implantable Medical Device Accreditation
AIMD 0101: Active implantable medical device for stimulation / inhibition
AIMD 0102: Active implantable medical device delivering drugs or other substances
AIMD 0103: Active implantable medical devices substituting or replacing organ functions

Horizontal Technical Competence      
IMDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
IMDS 7006: Medical devices in sterile condition

ANNEX 2: Complete Quality Assurance System
ANNEX 3: EC Type-Examination
ANNEX 4: EC Verification
ANNEX 5: Production Quality Assurance