INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s.
T. Bati 299
Louky, 76302 ZLIN
Country : Czech Republic
Phone : +420-577 601 238
Fax : +420-577 104 855
Email : pvanek@itczlin.cz
Notified Body number : 1023
Website : INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s.

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 1110: Active devices for in-vitro fertillisation and assisted reproductive therapy
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 7002: Medical devices utilising tissues of animal origin
MDS 7003: Medical devices incorporation derivatives of human blood
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
MDS 7006: Medical devices in sterile condition
MDS 7007: Medical devices utilizing micromechanics
MDS 7008: Medical devices utilising nanomaterials
MDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

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 7001: Medical devices incorporating medicinal substances
IMDS 7002: Medical devices utilising tissues of animal origin
IMDS 7003: Medical devices incorporation derivatives of human blood
IMDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
IMDS 7006: Medical devices in sterile condition
IMDS 7007: Medical devices utilizing micromechanics
IMDS 7008: Medical devices utilising nanomaterials
IMDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

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 measurement 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 7207: IVDs utilizing micromechanics
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 V: EC Type-Examination
ANNEX VI: EC-Verification
ANNEX VII: Production Quality Assurance

Laboratoire national d’essais / G-MED
1, rue Gaston Boissier
75724 PARIS Cedex 15
Country : France
Phone : +33 1 40 43 37 00
Fax : + 33 1 40 43 37 37
Email : info.gmed@lne.fr
Notified Body number : 0459
Website : Laboratoire national d’essais / G-MED

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 1110: Active devices for in-vitro fertillisation and assisted reproductive therapy
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 7002: Medical devices utilising tissues of animal origin
MDS 7003: Medical devices incorporation derivatives of human blood
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
MDS 7006: Medical devices in sterile condition
MDS 7007: Medical devices utilizing micromechanics
MDS 7008: Medical devices utilising nanomaterials
MDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

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 7001: Medical devices incorporating medicinal substances
IMDS 7002: Medical devices utilising tissues of animal origin
IMDS 7003: Medical devices incorporation derivatives of human blood
IMDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
IMDS 7006: Medical devices in sterile condition
IMDS 7007: Medical devices utilizing micromechanics
IMDS 7008: Medical devices utilising nanomaterials
IMDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

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 measurement 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 7207: IVDs utilizing micromechanics
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 V: EC Type-Examination
ANNEX VI: EC-Verification
ANNEX VII: Production Quality Assurance

AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS
Campezo 1. Edificio 8
28022 MADRID
Country : Spain
Phone : +34:91:822 52 52
Fax : +34:91:822 52 89
Email : on0318@aemps.es
Notified Body number : 0318
Website : AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS

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 1110: Active devices for in-vitro fertillisation and assisted reproductive therapy
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 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 7007: Medical devices utilizing micromechanics
MDS 7008: Medical devices utilising nanomaterials
MDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

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 7001: Medical devices incorporating medicinal substances
IMDS 7002: Medical devices utilising tissues of animal origin
IMDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
IMDS 7006: Medical devices in sterile condition
IMDS 7007: Medical devices utilizing micromechanics
IMDS 7008: Medical devices utilising nanomaterials
IMDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

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 7207: IVDs utilizing micromechanics
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 V: EC Type-Examination
ANNEX VI: EC-Verification
ANNEX VII: Production Quality Assurance

BSI
Kitemark Court
Davy Avenue
Knowhill
Milton Keynes MK5 8PP
Country : United Kingdom
Phone : +44 (0) 8450 809000
Fax : +44 (0) 8450 809000
Email : testing.services@bsigroup.com
Notified Body number : 0086
Website : BSI

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 1110: Active devices for in-vitro fertillisation and assisted reproductive therapy
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 7002: Medical devices utilising tissues of animal origin
MDS 7003: Medical devices incorporation derivatives of human blood
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

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 7001: Medical devices incorporating medicinal substances
IMDS 7002: Medical devices utilising tissues of animal origin
IMDS 7003: Medical devices incorporation derivatives of human blood
IMDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
IMDS 7006: Medical devices in sterile condition
IMDS 7007: Medical devices utilizing micromechanics
IMDS 7008: Medical devices utilising nanomaterials
IMDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

ANNEXES
ANNEX 2: Complete Quality Assurance System
ANNEX 3: EC Type-Examination
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 measurement of blood sugar
IVD 0401: Clinical chemistries (Self-Testing)
IVD 0402: Hematology (Self-Testing)
IVD 0403: Immunology (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 V: EC Type-Examination
ANNEX VI: EC-Verification
ANNEX VII: Production Quality Assurance

TÜV SÜD Product Service GmbH
Ridlerstraße 65
80339 MÜNCHEN
Country : Germany
Phone : +49 (89) 50084261
Fax : +49 (89) 50084230
Email : ps.zert@tuev-sued.de
Notified Body number : 0123
Website : TÜV SÜD Product Service 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 1110: Active devices for in-vitro fertillisation and assisted reproductive therapy
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 7002: Medical devices utilising tissues of animal origin
MDS 7003: Medical devices incorporation derivatives of human blood
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
MDS 7006: Medical devices in sterile condition
MDS 7007: Medical devices utilizing micromechanics
MDS 7008: Medical devices utilising nanomaterials
MDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

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 measurement 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 7207: IVDs utilizing micromechanics
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 V: EC Type-Examination
ANNEX VI: EC-Verification
ANNEX VII: Production Quality Assurance

TÜV Rheinland LGA Products GmbH
Tillystraße 2
90431 Nürnberg
Country : Germany
Phone : +49 (0) 911 655-5601
Fax : +49 (0) 911 655-5603
Email : christian.schelle@de.tuv.com
Notified Body number : 0197
Website : TÜV Rheinland LGA Products 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 1110: Active devices for in-vitro fertillisation and assisted reproductive therapy
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 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 7007: Medical devices utilizing micromechanics
MDS 7008: Medical devices utilising nanomaterials
MDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

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 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 measurement 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 7207: IVDs utilizing micromechanics
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 V: EC Type-Examination
ANNEX VI: EC-Verification
ANNEX VII: Production Quality Assurance

3EC International a.s.
Hraničná 18
Bratislava 82105
Country : Slovakia
Phone : +421 (2) 58318343
Fax : +421 (2) 58318345
Email : katarina.srdosova@3ec.sk
Notified Body number : 2265
Website : 3EC International a.s.

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 1110: Active devices for in-vitro fertillisation and assisted reproductive therapy
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 7002: Medical devices utilising tissues of animal origin
MDS 7003: Medical devices incorporation derivatives of human blood
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
MDS 7006: Medical devices in sterile condition
MDS 7007: Medical devices utilizing micromechanics
MDS 7008: Medical devices utilising nanomaterials
MDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

ANNEXES
MDD ANNEX II: Full Quality Assurance
MDD ANNEX V: Production Quality Assurance
MDD ANNEX VI: Product 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 measurement 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 7207: IVDs utilizing micromechanics
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

EVPU a.s.
Trencianska 19
018 51 NOVA DUBNICA
Country : Slovakia
Phone : +421 (42) 4403600
Fax : +421 (42) 4403502
Email : hudak@evpu.sk, vrankova@evpu.sk
Notified Body number : 1293
Website : EVPU a.s.

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 1110: Active devices for in-vitro fertillisation and assisted reproductive therapy
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 7003: Medical devices incorporation derivatives of human blood
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
MDS 7006: Medical devices in sterile condition
MDS 7007: Medical devices utilizing micromechanics
MDS 7008: Medical devices utilising nanomaterials
MDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

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

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 measurement 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 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 V: EC Type-Examination
ANNEX VI: EC-Verification
ANNEX VII: Production Quality Assurance

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

National Standards Authority of Ireland (NSAI)
1 Swift Square, Northwood, Santry
Dublin 9
Country : Ireland
Phone : +353.1.807.38.00
Fax : +353.1.807.39.25
Email : info@nsai.ie
Notified Body number : 0050
Website : National Standards Authority of Ireland (NSAI)

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 1107: Active devices for disinfection and sterilisation
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 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 7002: Medical devices utilising tissues of animal origin
MDS 7003: Medical devices incorporation derivatives of human blood
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
MDS 7006: Medical devices in sterile condition
MDS 7007: Medical devices utilizing micromechanics
MDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

ANNEXES
MDD ANNEX II: Full Quality Assurance
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 7001: Medical devices incorporating medicinal substances
IMDS 7002: Medical devices utilising tissues of animal origin
IMDS 7003: Medical devices incorporation derivatives of human blood
IMDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
IMDS 7006: Medical devices in sterile condition
IMDS 7007: Medical devices utilizing micromechanics
IMDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

ANNEXES
ANNEX 2: Complete Quality Assurance System
ANNEX 5: Production Quality Assurance

IVD Medical Device Accreditation
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 measurement 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 7207: IVDs utilizing micromechanics

ANNEXES
ANNEX IV: Full Quality Assurance System
ANNEX VII: Production Quality Assurance