Products |
Procedures |
Annexes |
Conditions |
I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
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- A. Active devices
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- 2. Active non-implantable devices for imaging, monitoring and/or diagnosis
- MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Active non-implantable devices for imaging, monitoring and/or diagnosis
- MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Active non-implantable devices for imaging, monitoring and/or diagnosis
- MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Active non-implantable devices for imaging, monitoring and/or diagnosis
- MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0301 Active non-implantable devices utilising ionizing radiation
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0302 Active non-implantable devices utilising non-ionizing radiation
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0304 Active non-implantable devices for shock-wave therapy (lithotripsy)
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0305 Active non-implantable devices for stimulation or inhibition
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Conformity assessment based on a quality management system Conformity assessment based on product quality assurance |
Annex IX(I) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0307 Active non-implantable respiratory devices
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Conformity assessment based on a quality management system Conformity assessment based on product quality assurance |
Annex IX(I) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0308 Active non-implantable devices for wound and skin care
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0309 Active non-implantable ophthalmologic devices
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0310 Active non-implantable devices for ear, nose and throat
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0311 Active non-implantable dental devices
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0312 Other active non-implantable surgical devices
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0314 Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitrofertilisation (IVF) and assisted reproductive technologies (ART)
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
excluding IVF and ART; limited to devices for cryopreservation |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0315 Software
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0316 Medical gas supply systems and parts thereof
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0318 Other active non-implantable devices
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- B. Non-active devices
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- 1. Non-active implants and long term surgically invasive devices
- MDN 1101 Non-active cardiovascular, vascular and neurovascular implants
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 1. Non-active implants and long term surgically invasive devices
- MDN 1102 Non-active osteo- and orthopaedic implants
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 1. Non-active implants and long term surgically invasive devices
- MDN 1103 Non-active dental implants and dental materials
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 1. Non-active implants and long term surgically invasive devices
- MDN 1104 Non-active soft tissue and other implants
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
excluding breast implants whose purpose is the enlargement or replacement of the volume of the breast |
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- 2. Non-active non-implantable devices
- MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Non-active non-implantable devices
- MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Non-active non-implantable devices
- MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Non-active non-implantable devices
- MDN 1204 Non-active non-implantable devices for wound and skin care
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Conformity assessment based on a quality management system Conformity assessment based on product quality assurance |
Annex IX(I) Annex XI(A) |
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- 2. Non-active non-implantable devices
- MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Non-active non-implantable devices
- MDN 1206 Non-active non-implantable ophthalmologic devices
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Non-active non-implantable devices
- MDN 1207 Non-active non-implantable diagnostic devices
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Non-active non-implantable devices
- MDN 1208 Non-active non-implantable instruments
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Non-active non-implantable devices
- MDN 1209 Non-active non-implantable dental materials
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Non-active non-implantable devices
- MDN 1210 Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Non-active non-implantable devices
- MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Non-active non-implantable devices
- MDN 1212 Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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- 2. Non-active non-implantable devices
- MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
excluding devices for ingestion |
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- 2. Non-active non-implantable devices
- MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices
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Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance |
Annex IX(I) Annex IX(II) Annex XI(A) |
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Horizontal technical competence |
Limitations |
MDS 1001 Devices incorporating medicinal substances |
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MDS 1002 Devices manufactured utilising tissues or cells of human origin, or their derivatives |
restricted to devices manufactured utilising human serum albumin (HSA) |
MDS 1003 Devices manufactured utilising tissues or cells of animal origin, or their derivatives |
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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) |
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MDS 1005 Devices in sterile condition |
including
aseptic processing;
ethylene oxide gas sterilisation (EOG);
low temperature steam and formaldehyde sterilisation;
moist heat sterilisation;
radiation sterilisation (gamma, x-ray, electron beam);
sterilisation with hydrogen peroxide;
sterilisation with liquid chemical sterilising agens; |
MDS 1006 Reusable surgical instruments |
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MDS 1007 Devices incorporating or consisting of nanomaterial |
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MDS 1008 Devices utilising biologically active coatings and/or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a chemical change in the body |
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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 |
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MDS 1010 Devices with a measuring function |
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MDS 1011 Devices in systems or procedure packs |
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MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 |
only products within the designation according to MDA/MDN-codes excluding products according to section 3 of annex XVI |
MDS 1013 Class III custom-made implantable devices |
only products within the designation according to MDA/MDN-codes |
MDS 1014 Devices incorporating as an integral part an in vitro diagnostic device |
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MDT 2001 Devices manufactured using metal processing |
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MDT 2002 Devices manufactured using plastic processing |
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MDT 2003 Devices manufactured using non-metal mineral processing (e.g. glass, ceramics) |
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MDT 2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper) |
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MDT 2005 Devices manufactured using biotechnology |
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MDT 2006 Devices manufactured using chemical processing |
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MDT 2007 Devices which require knowledge regarding the production of pharmaceuticals |
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MDT 2008 Devices manufactured in clean rooms and associated controlled environments |
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MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin |
only products within the designation according to MDA/MDN-codes |
MDT 2010 Devices manufactured using electronic components including communication devices |
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MDT 2011 Devices which require packaging, including labelling |
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MDT 2012 Devices which require installation, refurbishment |
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MDT 2013 Devices which have undergone reprocessing |
excluding reprocessing of single-use devices |