Notified Body 2962

Quality Medical Devices, Because Patient Safety Matters

Europe's regulatory framework puts patient safety first. QMD Services is the only Austrian Notified Body designated under both the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and the Medical Device Regulation (EU) 2017/745 (MDR).

We believe medical innovation only delivers real value when it is matched with quality and safety, and we assess every device with that in mind.

IVDR (EU) 2017/746MDR (EU) 2017/745Vienna & Linz, Austria

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Quality Medical Devices, Because Patient Safety Matters

Medical Device Safety

An Independent Guarantor for Patients

As a Notified Body, QMD Services acts as an independent third party. In one conformity assessment procedure centred on patient safety, we bring together the technical innovation of a device, its clinical evidence and its regulatory compliance.

Our Pillars

What We Stand For

Award Winning Experts

Recognised specialists in medical device and IVD assessment.

Independent & Impartial

Third-party evaluations free from any conflict of interest.

Compliance Focused

Regulatory requirements guide every step we take.

Focused on Patient Safety

Protecting the end user drives every certification decision.

Profound Medical Knowledge

Deep clinical and technical expertise across device categories.

Global Impact

International partners and experts supporting manufacturers worldwide.

Global Reach

Serving Manufacturers Around the World

From our base in Austria, a network of international partners and an expert team spread across several countries lets us support manufacturers wherever they are.

Our Services Partner Network

Scope of Designation

What We Can Certify

Our designation covers the codes below. Select a group to see the individual codes and any limitations.

MDR, Regulation (EU) 2017/745

Active medical devices (MDA)+-

MDA 0203Devices for monitoring vital physiological parameters

MDA 0204Other active diagnostic and monitoring devices (excluding audiometers, tonometers and fundus cameras)

MDA 0302Devices using non-ionizing radiation (excluding pain lasers, phototherapy, echo robots and refractive surgery lasers)

MDA 0305Active stimulation or inhibition devices (excluding electroacupuncture)

MDA 0306Devices for extracorporeal circulation and administration or removal of substances (excluding blood pumps for heart-lung machines)

MDA 0307Active respiratory devices (excluding hyperbaric oxygen chambers)

MDA 0312Other active surgical devices (excluding pressure regulators for surgical sealants)

MDA 0315Software (excluding radiotherapy planning systems)

MDA 0318Other active non-implantable devices

Non-active medical devices (MDN)+-

MDN 1101Non-active cardiovascular, vascular and neurovascular implants

MDN 1102Non-active osteo- and orthopaedic implants (excluding intervertebral discs, joint prostheses, hyaluronic acid implants and ligament products)

MDN 1104Non-active soft tissue implants (limited to hernia meshes, urethral stents, sutures, collagen implants, adhesion prevention and haemostatic agents)

MDN 1201Non-active devices for anaesthesia, emergency and intensive care

MDN 1202Non-active devices for administration, channelling and removal of substances, including dialysis (excluding filters and fluids)

MDN 1203Guiding catheters, balloon catheters, guidewires, introducers and filters (excluding embolectomy catheters)

MDN 1208Instruments for surgical use (excluding dental)

MDN 1211Devices for disinfecting and cleaning (limited to disinfectant solutions and wipes)

Horizontal technical competences (MDS)+-

MDS 1003Devices utilising tissues or cells of animal origin

MDS 1004Devices that are also machinery under Directive 2006/42/EC

MDS 1005Devices in sterile condition (aseptic processing, ethylene oxide, moist heat, gamma, x-ray and electron beam sterilisation)

MDS 1006Reusable surgical instruments

MDS 1009Devices incorporating or controlled by software

MDS 1010Devices with a measuring function

MDS 1011Devices in systems or procedure packs

MDS 1014Devices incorporating an in vitro diagnostic device

Technology-based competences (MDT)+-

MDT 2001Devices manufactured using metal processing

MDT 2002Devices manufactured using plastic processing

MDT 2003Non-metal mineral processing (glass, ceramics)

MDT 2004Non-metal, non-mineral processing (textiles, rubber, leather, paper)

MDT 2006Devices manufactured using chemical processing

MDT 2008Devices manufactured in clean rooms

MDT 2009Processing of materials of human, animal or microbial origin

MDT 2010Devices using electronic components

MDT 2011Devices requiring packaging and labelling

MDT 2012Devices requiring installation or refurbishment

IVDR, Regulation (EU) 2017/746

Tumour and non-malignant markers (IVR 03)+-

IVR 0301Devices for cancer screening, diagnosis, staging or monitoring

IVR 0302Cancer and non-malignant tumour markers

Human genetic testing (IVR 04)+-

IVR 0401Screening for congenital or inherited disorders

IVR 0402Predicting risk or prognosis of hereditary disease

IVR 0403Other human genetic testing devices

Infection and immune status (IVR 05)+-

IVR 0501Prenatal screening of immune status

IVR 0502Assessing suitability for transfusion or transplantation

IVR 0503Detection of infectious agents

IVR 0504Determining infectious load or immune status

IVR 0505Culturing, isolating or identifying infectious agents

IVR 0506Other markers of infection or immune status

Non-infectious diseases and physiological status (IVR 06)+-

IVR 0601Screening or confirming disorders and impairments

IVR 0602Screening or monitoring physiological markers of disease

IVR 0603Screening or monitoring allergies and intolerances

IVR 0604Other disease-specific devices

IVR 0605Monitoring levels of drugs, substances or biological components

IVR 0606Staging of non-infectious diseases

IVR 0607Pregnancy and fertility testing

IVR 0608Screening or monitoring physiological markers

IVR 0609Monitoring physiological state and therapy

Controls and sterile devices (IVR 07 / 08)+-

IVR 0701Controls without a quantitative assigned value

IVR 0702Controls without a qualitative assigned value

IVR 0801Sterile devices under Annex VIII rule 5(a)

IVR 0802Instruments intended for in vitro procedures

IVR 0803Specimen receptacles

Horizontal technical competences (IVD)+-

IVD 4001Bacteriology

IVD 4002Clinical chemistry and biochemistry

IVD 4004Genetics

IVD 4005Haematology, haemostasis and coagulation

IVD 4007Immunohistochemistry and histology

IVD 4008Immunology

IVD 4009Molecular biology and diagnostics

IVD 4010Mycology

IVD 4011Parasitology

IVD 4012Virology

Procedure-based competences (IVP)+-

IVP 3001Agglutination tests

IVP 3002Biochemistry

IVP 3003Chromatography

IVP 3004Chromosomal analysis

IVP 3005Coagulometry

IVP 3006Flow cytometry

IVP 3007Immunoassays

IVP 3008Lysis-based testing

IVP 3010Microscopy

IVP 3011Molecular biological testing, including NGS

IVP 3012Physical chemistry and electrochemistry

IVP 3013Spectroscopy

IVP 3014Cell function testing

Setting-based competences (IVS)+-

IVS 1001Near-patient testing devices

IVS 1002Self-testing devices

IVS 1003Companion diagnostics

IVS 1004Devices using tissues or cells of human origin

IVS 1005Sterile devices (aseptic processing, ethylene oxide, moist heat, gamma and electron beam sterilisation)

IVS 1006Calibrators

IVS 1007Quantitative and qualitative control materials

IVS 1008Instruments, equipment and systems

IVS 1009Standalone software, including data analysis apps

IVS 1010Devices incorporating or controlled by software

Technology-based competences (IVT)+-

IVT 2001Metal processing

IVT 2002Plastic processing

IVT 2003Non-metal mineral processing (glass, ceramics)

IVT 2004Non-metal, non-mineral processing (textiles, rubber, leather, paper)

IVT 2005Biotechnology

IVT 2006Chemical processing

IVT 2008Clean room manufacturing

IVT 2009Processing of materials of human, animal or microbial origin

IVT 2010Devices using electronic components

IVT 2011Devices requiring packaging and labelling

Official scope: the complete and binding scope statement is published in the European Commission NANDO database.

Download MDR/IVDR Brochure

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+91 95996 19392 info@qacamail.com

Medical Devices