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Product range

93/42/EEC Medical devices

EN ISO/IEC 17021

Certification of management systems

EN ISO/IEC 17025

Testing and calibration laboratories

MD 0100

General non-active, non-implantable
medical devices

MD 0101

Non-active devices for anaesthesia,
emergency and intensive care

MD 0102

Non-active devices for injection, infusion,
transfusion and dialysis

MD 0103

Non-active orthopaedic and rehabilitation

MD 0104

Non-active medical devices with
measuring function

MD 0105

Non-active ophthalmologic devices

MD 0106

Non-active instruments

MD 0108

Non-active medical devices for
disinfecting, cleaning, rinsing

MD 0110

Non-active medical devices for ingestion

MD 0200

Non-active implants

MD 0202

Non-active orthopaedic implants

MD 0300

Devices for wound care

MD 0301

Bandages and wound dressings

MD 0302

Suture material and clamps

MD 0303

Other medical devices for wound care

MD 0400

Non-active dental devices and accessories

MD 0401

Non-active dental equipment and

MD 0402

Dental materials

MD 0403

Dental implants

MD 1100

General active medical devices

MD 1102

Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation

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

MD 1108

 Active rehabilitation devices and active

MD 1109

 Active devices for patient positioning and

MD 1111


MD 1112

 Medical gas supply systems and parts

MD 1200

Devices for imaging

MD 1201

Imaging devices utilising ionizing

MD 1202

 Imaging devices utilising non-ionizing

MD 1300

Monitoring devices

MD 1301

Monitoring devices of non-vital
physiological parameters

MD 1302

Monitoring devices of vital physiological

MD 1400

Devices for radiation therapy and thermo

MD 1401

Devices utilising ionizing radiation

MD 1402

Devices utilising non-ionizing radiation

MD 1403

Devices for hyperthermia / hypothermia

MD 1404

Devices for (extracorporal) shock-wave
therapy (lithotripsy)

Horizontal technical competence

MDS 7004

Medical devices referencing the Directive 2006/42/EC on machinery

MDS 7006

Medical devices in sterile condition

MDS 7010

Medical devices incorporating software /utilising software /controlled by software

Regulation (EU) 2017/745 on medical devices

MDA 0201

Active non-implantable imaging devices
utilising ionizing radiation

MDA 0202

Active non-implantable imaging devices
utilising non-ionizing radiation

MDA 0203

Active non-implantable devices for
monitoring of vital physiological parameters

MDA 0204

Other active non-implantable devices
for monitoring and/or diagnosis

MDA 0301

Active non-implantable devices utilising
ionizing radiation

MDA 0303

Active non-implantable devices utilising

MDA 0304

Active non-implantable devices for
shock-wave therapy (lithotripsy)

MDA 0305

Active non-implantable devices for
stimulation or inhibition

MDA 0307

Active non-implantable respiratory

MDA 0309

Active non-implantable ophthalmologic

MDA 0311

Active non-implantable dental devices

MDA 0313

Active non-implantable prostheses,
devices for rehabilitation and devices for patient
positioning and transport

MDA 0315


MDA 0317

Active non-implantable devices for
cleaning, disinfection and sterilisation

MDA 0318

Other active non-implantable devices

MDN 1205

Non-active non-implantable
orthopaedic and rehabilitation devices

MDN 1207

Non-active non-implantable diagnostic devices

MDN 1208

Non-active non-implantable instruments

MDN 1211

Non-active non-implantable devices for
disinfecting, cleaning and rinsing

MDN 1214

General non-active non-implantable
devices used in health care and other non-active
non-implantable devices

Horizontal technical competence

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

MDS 1005

Devices in sterile condition

MDS 1007

Devices incorporating or consisting of nanomaterial

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 1012

Products without an intended medical purpose listed in Annex XVI to
Regulation (EU) 2017/745

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 2010

Devices manufactured using electronic components including communication devices

MDT 2011

Devices which require packaging, including labelling

MDT 2012

Devices which require installation, refurbishment

2014/30/EU Electromagnetic compatibility

EN ISO/IEC 17065

Product certification

Regulation (EU) No 305/2011 - Construction products

EN 1090-1:+A1


EN 50575:/A1


 2014/68/EU Pressure equipment

EN ISO/IEC 17020