We certify
Because Patient Safety Matters
The European Union’s regulatory environment for medical devices focuses on patient safety.
In this environment, a Notified Body is an independent guarantor that technical innovation, clinical evidence and regulatory compliance are combined in a robust and legally secure conformity assessment procedure that prioritises patient safety.
QMD Services is the only Austrian Notified Body to cover both Regulation (EU) 2017/746 (IVDR) and Regulation (EU) 2017/745 (MDR).
It’s in our DNA that medical device innovation alone is not enough.
It is innovation paired with quality and safety that yields us the results that make our hearts sing.
At QMD Services, we strive to create more than just certificates. We contribute to the safety of your medical devices, always keeping the patient and user in mind.
Award Winning Experts
Independent & Impartial
Compliance Focused
Focused on Patient Safety
Profound Medical Knowledge
Global Impact
In addition to providing recognised certification to the Austrian medical device industries, QMD has an international reach.
Partners
Employees and Experts
Partners
Employees and Experts
QMD Services is the only Austrian notified body to cover both Regulation (EU) 2017/746 (IVDR) and Regulation (EU) 2017/745 (MDR).
Find below the scope of designation of QMD Services as published on NANDO:
MDA 0203
Active non-implantable devices for monitoring vital physiological parameters (no restrictions).
MDA 0204
Other active non-implantable monitoring and/or diagnostic devices (excluding audiometers, tonometers, and fundus cameras).
MDA 0302
Active non-implantable devices using non-ionizing radiation (excluding pain therapy lasers, patient phototherapy devices, non-invasive echo treatment robots for varicose veins, and ophthalmic refractive surgery lasers).
MDA 0305
Active non-implantable devices for stimulation or inhibition (excluding electroacupuncture devices).
MDA 0306
Active non-implantable devices for extracorporeal circulation, substance administration/removal, and blood separation (excluding blood pumps for heart-lung machines).
MDA 0307
Active non-implantable respiratory devices (excluding hyperbaric oxygen chambers)
MDA 0312
Other active non-implantable surgical devices (excluding pressure regulators for surgical sealant or hemostatic sprays).
MDA 0315
Software (excluding radiotherapy planning systems).
MDA 0318
Other active non-implantable devices (no restrictions).
MDN 1101
Passive cardiovascular, vascular, and neurovascular implants (no restrictions).
MDN 1102
Passive bone and orthopedic implants (excluding artificial intervertebral discs, joint replacement prostheses such as knee and hip implants, intra-articular hyaluronic acid implants, and synthetic ligament reconstruction products).
MDN 1104
Passive soft tissue and other implants (limited to hernia meshes, urethral stent implants, sutures, collagen soft tissue implants, adhesion-prevention implants, and collagen-based hemostatic or sealing agents).
MDN 1201
Passive non-implantable devices for anesthesia, emergency care, and intensive care (no restrictions).
MDN 1202
Passive non-implantable devices for substance administration, guidance, and removal (including dialysis equipment, but excluding dialysis filters and dialysis fluids).
MDN 1203
MDN 1208
Passive non-implantable instruments (excluding dental instruments).
MDN 1211
Passive non-implantable devices for disinfection, cleaning, and rinsing (limited to disinfectant solutions and wipes for medical devices).
MDS 1003
Devices manufactured utilising tissues or cells of animal origin, or their derivatives
MDS 1004
Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1)
MDS 1005
Devices in sterile condition
Limitations: aseptic processing, ethylene oxide gas sterilisation (EOG), moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam)
MDS 1006
Reusable surgical instruments
MDS 1009
Devices incorporating software/utilising software/controlled by software, including devices intended for controlling, monitoring or directly influencing the Performance of active or active implantable devices
MDS 1010
Devices with a measuring function
MDS 1011
Devices in systems or procedure packs
MDS 1014
Devices incorporating as an integral part an in vitro diagnostic device
MDT 2001
Devices manufactured using metal processing
MDT 2002
Devices manufactured using plastic processing
MDT 2003
Devices manufactured using non-metal Mineral processing (e.g. glass, ceramics)
MDT 2004
Devices manufactured using non-metal non-Mineral processing (e.g. textiles, rubber, leather, paper)
MDT 2006
Devices manufactured using chemical processing
MDT 2008
Devices manufactured in clean rooms and associated controlled environments
MDT 2009
Devices manufactured using processing of materials of human, animal, or microbial origin
MDT 2010
Devices manufactured using electronic components including communication devices
MDT 2011
Devices which require packaging, including labelling
MDT 2012
Devices which require installation, refurbishment
IVR 0301
Devices for cancer screening, diagnosis, staging, or monitoring
IVR 0302
Other devices for cancer and non-malignant tumor markers
Applicable Annexes: Annex IX(I), Annex IX(II), Annex XI
IVR 0401
Devices for screening/confirmation of congenital or hereditary diseases
IVR 0402
Devices for predicting risk or prognosis of hereditary diseases
IVR 0403
Other devices for human genetic testing
Applicable Annexes: Annex IX(I), Annex IX(II), Annex XI
IVR 0501
Devices for prenatal screening of pregnant women to determine immunity to transmissible agents
IVR 0502
Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, Transplantation or cell administration
IVR 0503
Devices for detecting infectious agents (including sexually transmitted agents)
IVR 0504
Devices for determining infection load, disease state, immune status, or stage of infectious disease
IVR 0505
Devices for culturing, isolating, identifying, and handling infectious agents
IVR 0506
Other devices for determining infection/immune status markers
Applicable Annexes: Annex IX(I), Annex IX(II), Annex XI
IVR 0601
IVR 0602
Devices for screening, measuring, or monitoring physiological markers of specific diseases
IVR 0603
Devices for screening, confirmation, measurement, or monitoring of allergies and intolerances
IVR 0604
Other devices for specific diseases
IVR 0605
Devices for monitoring drug, substance, or biological component levels
IVR 0606
Devices for staging of non-infectious diseases
IVR 0607
Devices for pregnancy detection or fertility testing
IVR 0608
Devices for screening, measuring, or monitoring physiological markers
IVR 0609
Other devices for defining or monitoring physiological states and therapeutic measures
Applicable Annexes: Annex IX(I), Annex IX(II), Annex XI
IVR 0701
Devices which are controls without a quantitative assigned value
IVR 0702
Applicable Annexes: Annex IX(I), Annex IX(II), Annex XI
IVR 0801
Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746
IVR 0802
Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746
IVR 0803
Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746
Applicable Annexes: Annex IX(I), Annex IX(II), Annex XI
IVD 4001
In vitro diagnostic devices which require knowledge regarding bacteriology
IVD 4002
In vitro diagnostic devices which require knowledge regarding clinical chemistry/biochemistry
IVD 4004
In vitro diagnostic devices which require knowledge regarding genetics
IVD 4005
In vitro diagnostic devices which require knowledge regarding haematology/haemostasis, including coagulation disorders
IVD 4007
In vitro diagnostic devices which require knowledge regarding immunohistochemistry/histology
IVD 4008
In vitro diagnostic devices which require knowledge regarding immunology
IVD 4009
In vitro diagnostic devices which require knowledge regarding molecular biology/diagnostics
IVD 4010
In vitro diagnostic devices which require knowledge regarding mycology
IVD 4011
In vitro diagnostic devices which require knowledge regarding parasitology
IVD 4012
In vitro diagnostic devices which require knowledge regarding virology
IVP 3001
In vitro diagnostic devices which require knowledge regarding agglutination tests
IVP 3002
In vitro diagnostic devices which require knowledge regarding biochemistry
IVP 3003
In vitro diagnostic devices which require knowledge regarding chromatography
IVP 3004
In vitro diagnostic devices which require knowledge regarding chromosomal analysis
IVP 3005
In vitro diagnostic devices which require knowledge regarding coagulometry
IVP 3006
In vitro diagnostic devices which require knowledge regarding flow cytometry
IVP 3007
In vitro diagnostic devices which require knowledge regarding immunoassays
IVP 3008
In vitro diagnostic devices which require knowledge regarding lysis based testing
IVP 3010
In vitro diagnostic devices which require knowledge regarding microscopy
IVP 3011
In vitro diagnostic devices which require knowledge regarding molecular biological testing including nucleic acid assays and next generation sequencing (NGS):IVP 3012 In vitro diagnostic devices which require knowledge regarding physical chemistry including electrochemistry
IVP 3013
In vitro diagnostic devices which require knowledge regarding spectroscopy
IVP 3014
In vitro diagnostic devices which require knowledge regarding tests of cell function
IVS 1001
Devices intended to be used for near-patient testing
IVS 1002
Devices intended to be used for self-testing
IVS 1003
Devices intended to be used as companion diagnostics
IVS 1004
Devices manufactured utilising tissues or cells of human origin, or their derivatives
IVS 1005
Devices in sterile condition
Limitations: aseptic processing, ethylene oxide gas sterilisation (EOG), moist heat sterilisation, radiation sterilisation: gamma, Radiation sterilisation: electron beam
IVS 1006
Calibrators (point 1.5 of Annex VIII to Regulation (EU) 2017/746)
IVS 1007
Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes (point 1.6 of Annex VIII to Regulation (EU) 2017/746)
IVS 1008
Instruments, equipment, systems or apparatus
IVS 1009
Software that are devices in themselves including software apps, software for data analysis, and for defining or monitoring therapeutic measures
IVS 1010
Devices incorporating software/utilising software/controlled by software
IVT 2001
In vitro diagnostic devices manufactured using metal processing
IVT 2002
In vitro diagnostic devices manufactured using plastic processing
IVT 2003
In vitro diagnostic devices manufactured using non-metal mineral processing (e.g. glass, ceramics)
IVT 2004
In vitro diagnostic devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)
IVT 2005
In vitro diagnostic devices manufactured using biotechnology
IVT 2006
In vitro diagnostic devices manufactured using chemical processing
IVT 2008
In vitro diagnostic devices manufactured in clean rooms and associated controlled environments
IVT 2009
In vitro diagnostic devices manufactured using processing of materials of human, animal or microbial origin
IVT 2010
In vitro diagnostic devices manufactured using electronic components including communication devices
IVT 2011
In vitro diagnostic devices which require packaging, including labelling