BSI Group Deutschland GmbH
Hanauer Landstrasse 115
60314 Frankfurt am Main
Country : Germany
Phone : +49 (69) 22 22 89 200
Fax : +49 (69) 22 22 89 300
Email : md-cert.de@bsigroup.com
Website : www.bsigroup.de
Notified Body number : 0535
Website : BSI Group Deutschland 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 0106: Non-active instruments
MD 0108: Non-active medical devices for disinfecting, cleaning, rinsing
MD 0201: Non-active cardiovascular implants
MD 0202: Non-active orthopedic 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
MD 1403: Devices for hyperthermia / hypothermia
MD 1404: Devices for (extracorporeal) shock-wave therapy (lithripsy)
Horizontal Technical Competence
MDS 7001: Medical devices incorporating medicinal substances
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
MDS 7006: Medical devices in sterile condition
ANNEXES
MDD ANNEX II: Full Quality Assurance
MDD ANNEX III: EC-Type Examination
MDD ANNEX IV: EC Verification
MDD ANNEX V: Production Quality Assurance
MDD 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
ANNEXES
ANNEX 2: Complete Quality Assurance System
ANNEX 3: EC Type-Examination
ANNEX 4: EC Verification
ANNEX 5: Production Quality Assurance
IVD Medical Device Accreditation
IVD 0101: ABO System
IVD 0102: Rhesus (C,c,D,E,e)
IVD 0103: Anti-Kell
IVD 0201: HIV Infection
IVD 0202: HTLV I and II
IVD 0203: Hepatitis B, C and D
IVD 0301: Anti-Duffy and anti-Kidd
IVD 0302 Irregular anti-erythrocytic antibodies
IVD 0303: Congenital infections: rubella, toxoplasmosis
IVD 0304: Hereditary disease: phenylketouria
IVD 0305: Human infections: cytomegalovirus, chlamidia
IVD 0306: HLA tissue groups: DR, A, B
IVD 0307: Tomoral marker: PSA IVD 0308: Risk of trisomy 21
IVD 0309: Device for self-diagnosis for ,easurement of blood sugar
IVD 0401: Clinical chemistries (Self-Testing)
IVD 0402: Hematology (Self-Testing)
IVD 0403: Immunology (Self-Testing)
IVD 0404: Molecular biology (Self-Testing)
IVD 0405: Pregnancy and ovulation (Self-Testing)
IVD 0406: Speciment recepticles (Self-Testing)
Horizontal Technical Competence
MDS 7206: IVDs in sterile condition
MDS 7208: IVDs utilising nanomaterials
MDS 7209: IVDs utilising biological active coatings and/or materials
MDS 7210: IVDs utilising material of human origin
ANNEXES
ANNEX IV: Full Quality Assurance System
ANNEX VII: Production Quality Assurance