Designation codes
MDR/IVDR codes from Commission Implementing Regulation (EU) 2017/2185 define what each body is competent to assess under the medical device regulations. MID codes (MI-001–MI-010) are the instrument categories from Annex I of Directive 2014/32/EU. Select any code to see the bodies designated for it.
MDA — Active devices — design & intended purpose
| Code | Description | Bodies |
|---|---|---|
| MDA 0101 | Active implantable devices for stimulation / inhibition / monitoring | 1 |
| MDA 0102 | Active implantable devices delivering drugs or other substances | 0 |
| MDA 0103 | Active implantable devices supporting or replacing organ functions | 1 |
| MDA 0104 | Active implantable devices utilising radiation and other active implantable devices | 0 |
| MDA 0201 | Active non-implantable imaging devices utilising ionizing radiation | 6 |
| MDA 0202 | Active non-implantable imaging devices utilising non-ionizing radiation | 8 |
| MDA 0203 | Active non-implantable devices for monitoring of vital physiological parameters | 11 |
| MDA 0204 | Other active non-implantable devices for monitoring and / or diagnosis | 11 |
| MDA 0301 | Active non-implantable devices utilising ionizing radiation | 4 |
| MDA 0302 | Active non-implantable devices utilising non-ionizing radiation | 8 |
| MDA 0303 | Active non-implantable devices utilising hyperthermia / hypothermia | 7 |
| MDA 0304 | Active non-implantable devices for shock-wave therapy (lithotripsy) | 3 |
| MDA 0305 | Active non-implantable devices for stimulation or inhibition | 8 |
| MDA 0306 | Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis | 10 |
| MDA 0307 | Active non-implantable respiratory devices | 10 |
| MDA 0308 | Active non-implantable devices for wound and skin care | 11 |
| MDA 0309 | Active non-implantable ophthalmologic devices | 5 |
| MDA 0310 | Active non-implantable devices for ear, nose and throat | 7 |
| MDA 0311 | Active non-implantable dental devices | 10 |
| MDA 0312 | Other active non-implantable surgical devices | 11 |
| MDA 0313 | Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport | 10 |
| MDA 0314 | Active non-implantable devices for processing and preservation of human cells, tissues or organs including IVF and ART | 2 |
| MDA 0315 | Software | 12 |
| MDA 0316 | Medical gas supply systems and parts thereof | 8 |
| MDA 0317 | Active non-implantable devices for cleaning, disinfection and sterilisation | 8 |
| MDA 0318 | Other active non-implantable devices | 11 |
MDN — Non-active devices — design & intended purpose
| Code | Description | Bodies |
|---|---|---|
| MDN 1101 | Non-active cardiovascular, vascular and neurovascular implants | 9 |
| MDN 1102 | Non-active osteo- and orthopaedic implants | 11 |
| MDN 1103 | Non-active dental implants and dental materials | 10 |
| MDN 1104 | Non-active soft tissue and other implants | 9 |
| MDN 1201 | Non-active non-implantable devices for anaesthesia, emergency and intensive care | 11 |
| MDN 1202 | Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis | 11 |
| MDN 1203 | Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools | 9 |
| MDN 1204 | Non-active non-implantable devices for wound and skin care | 11 |
| MDN 1205 | Non-active non-implantable orthopaedic and rehabilitation devices | 7 |
| MDN 1206 | Non-active non-implantable ophthalmologic devices | 8 |
| MDN 1207 | Non-active non-implantable diagnostic devices | 7 |
| MDN 1208 | Non-active non-implantable instruments | 11 |
| MDN 1209 | Non-active non-implantable dental materials | 11 |
| MDN 1210 | Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases | 6 |
| MDN 1211 | Non-active non-implantable devices for disinfecting, cleaning and rinsing | 11 |
| MDN 1212 | Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including IVF and ART | 4 |
| 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 | 10 |
| MDN 1214 | General non-active non-implantable devices used in health care and other non-active non-implantable devices | 10 |
MDS — Horizontal — specific device characteristics
| Code | Description | Bodies |
|---|---|---|
| MDS 1001 | Devices incorporating medicinal substances | 0 |
| MDS 1002 | Devices manufactured utilising tissues or cells of human origin, or their derivatives | 0 |
| MDS 1003 | Devices manufactured utilising tissues or cells of animal origin, or their derivatives | 0 |
| MDS 1004 | Devices which are also machinery as defined in Directive 2006/42/EC | 0 |
| MDS 1005 | Devices in sterile condition | 0 |
| MDS 1006 | Reusable surgical instruments | 0 |
| MDS 1007 | Devices incorporating or consisting of nanomaterial | 0 |
| MDS 1008 | Devices utilising biologically active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body or intended to undergo a chemical change in the body | 0 |
| MDS 1009 | Devices incorporating / utilising / controlled by software, including devices controlling, monitoring or influencing active or active implantable devices | 0 |
| MDS 1010 | Devices with a measuring function | 0 |
| MDS 1011 | Devices in systems or procedure packs | 0 |
| MDS 1012 | Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 | 0 |
| MDS 1013 | Class III custom-made implantable devices | 0 |
| MDS 1014 | Devices incorporating as an integral part an in vitro diagnostic device | 0 |
MDT — Horizontal — manufacturing technologies & processes
| Code | Description | Bodies |
|---|---|---|
| MDT 2001 | Devices manufactured using metal processing | 0 |
| MDT 2002 | Devices manufactured using plastic processing | 0 |
| MDT 2003 | Devices manufactured using non-metal mineral processing (e.g. glass, ceramics) | 0 |
| MDT 2004 | Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper) | 0 |
| MDT 2005 | Devices manufactured using biotechnology | 0 |
| MDT 2006 | Devices manufactured using chemical processing | 0 |
| MDT 2007 | Devices which require knowledge regarding the production of pharmaceuticals | 0 |
| MDT 2008 | Devices manufactured in clean rooms and associated controlled environments | 0 |
| MDT 2009 | Devices manufactured using processing of materials of human, animal, or microbial origin | 0 |
| MDT 2010 | Devices manufactured using electronic components including communication devices | 0 |
| MDT 2011 | Devices which require packaging, including labelling | 0 |
| MDT 2012 | Devices which require installation, refurbishment | 0 |
| MDT 2013 | Devices which have undergone reprocessing | 0 |
IVR — Devices for specific markers / determinations
| Code | Description | Bodies |
|---|---|---|
| IVR 0101 | Devices intended to determine markers of the ABO blood group system | 0 |
| IVR 0102 | Devices intended to determine markers of the Rhesus blood group system | 0 |
| IVR 0103 | Devices intended to determine markers of the Kell blood group system | 0 |
| IVR 0104 | Devices intended to determine markers of the Kidd blood group system | 0 |
| IVR 0105 | Devices intended to determine markers of the Duffy blood group system | 0 |
| IVR 0106 | Other devices intended to be used for blood grouping | 0 |
| IVR 0201 | Devices for tissue typing (HLA A, B, DR) to ensure immunological compatibility of blood, components, cells, tissue or organs | 0 |
| IVR 0202 | Other devices intended to be used for tissue typing | 0 |
| IVR 0301 | Devices intended to be used in screening, diagnosis, staging or monitoring of cancer | 2 |
| IVR 0302 | Other devices intended to be used for markers of cancer and non-malignant tumours | 2 |
| IVR 0401 | Devices intended to be used in screening/confirmation of congenital/inherited disorders | 2 |
| IVR 0402 | Devices intended to be used to predict genetic disease/disorder risk and prognosis | 2 |
| IVR 0403 | Other devices intended to be used for human genetic testing | 2 |
| IVR 0501 | Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents | 2 |
| 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 | 2 |
| IVR 0503 | Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents | 2 |
| IVR 0504 | Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging | 2 |
| IVR 0505 | Devices intended to be used to grow/isolate/identify and handle infectious agents | 2 |
| IVR 0506 | Other devices intended to be used to determine markers of infections/immune status | 2 |
| IVR 0601 | Devices intended to be used for screening/confirmation of specific disorders/impairments | 2 |
| IVR 0602 | Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease | 2 |
| IVR 0603 | Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances | 2 |
| IVR 0604 | Other devices intended to be used for a specific disease | 2 |
| IVR 0605 | Devices intended to be used for monitoring of levels of medicinal products, substances or biological components | 2 |
| IVR 0606 | Devices intended to be used for non-infectious disease staging | 2 |
| IVR 0607 | Devices intended to be used for detection of pregnancy or fertility testing | 2 |
| IVR 0608 | Devices intended to be used for screening, determination or monitoring of physiological markers | 2 |
| IVR 0609 | Other devices intended to be used to define or monitor physiological status and therapeutic measures | 2 |
| IVR 0701 | Devices which are controls without a quantitative assigned value | 1 |
| IVR 0702 | Devices which are controls without a qualitative assigned value | 1 |
| IVR 0801 | Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746 | 1 |
| 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 | 1 |
| IVR 0803 | Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746 | 1 |
IVS — Horizontal — specific device characteristics
| Code | Description | Bodies |
|---|---|---|
| IVS 1003 | Devices intended to be used as companion diagnostics | 0 |
IVP — Devices requiring specific test knowledge
IVD — Devices requiring specific discipline knowledge
MI — Measuring instruments — instrument category
| Code | Description | Bodies |
|---|---|---|
| MI-001 | Water meters | 22 |
| MI-002 | Gas meters and volume conversion devices | 19 |
| MI-003 | Active electrical energy meters | 33 |
| MI-004 | Heat meters | 19 |
| MI-005 | Measuring systems for continuous and dynamic measurement of quantities of liquids other than water | 53 |
| MI-006 | Automatic weighing instruments | 40 |
| MI-007 | Taximeters | 17 |
| MI-008 | Material measures | 30 |
| MI-009 | Dimensional measuring instruments | 18 |
| MI-010 | Exhaust gas analysers | 16 |
The complete IVDR code inventory (IVR/IVS/IVT/IVP/IVD) is tracked in the data layer; per-code descriptions for codes not yet shown above are populated from IR 2017/2185 during the live data load.