1 
 Medical Device       
Medical Device Coordination Group Document   MDCG  2019-14    
 
  
 
 
 
MDCG  2019-14  
        Explanatory note on MDR codes   
           
 
           December   2019 
 
 
  
    
This document has been endorsed by the Medical Device Coordination Group 
(MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a 
representative of the European Commission. 
The document is not a European Commission document and it cannot be regarded 
as reflecting the official position of the European Commission. Any views expressed 
in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.  
   
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 Explanatory note on MDR codes 
 
1 Introduction 
Commission Implementing Regulation 2017/2185 establishes the codes for the designation of notified 
bodies in medical devices under Regulation (EU) 2017/745 and in vitro  diagnostic medical devices 
under Regulation (EU) 2017/746.  These codes are primarily used by designating authorities to define 
the notified body scope of designation but they are also used by the notified body to:  
1) describe the individual qualification of the NBs staff members 2) describe the qualification required for assessing a device  
These codes may be very broad and, furthermore, unequivocal authorisation of personnel to codes 
and the assignment of codes to a device is not always straightforward. However, the notified body’s system needs to ensure, in all cases, that the authorisation of personnel and team allocation for the conformity assessment of a device ensures adequate knowledge and expertise.  
 
2 Scope 
The lists of codes and corresponding types of devices established by the above mentioned 
Regulation takes into account various device types which can be characterised by design and intended purpose, manufacturing processes and technologies used, such as sterilisation and the use of nanomaterials.  
These lists of codes should be used in a way that provides for a multi-dimensional application to all 
typology of devices. This will ensure that notified bodies as well as the staff assigned to conformity assessment are fully competent for the devices they are required to assess. 
This guidance is intended to explain the different level of codes and how they should be used, 
including the use of conditions with a view to ensure a harmonised use of the codes especially for the allocation of resources to conformity assessment activities.  
 
 
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 3 Assignment of codes to devices within the conformity 
assessment procedure 
When a manufacturer lodges an application with a notified body, the type of devices and technologies 
subject to conformity assessment activities are to be indicated. Usually, at the application review stage (as defined in section 4.3 of Annex VII MDR), notified bodies will verify the assignment of codes provided by the manufacturer or will assign these codes to the devices themselves. This verification is carried out in order to ensure that the notified body is able to assess the application based on its designation, and that it has available resources to carry out the relevant conformity assessment 
activities (feasibility evaluation). The final assignment is made by the NB.  
After this application review, and signing of the contract, the notified body will allocate appropriately 
qualified and authorised personnel to carry out audit activities or product reviews.  
The following table presents an overview of the different types of codes and a summary of the main 
characteristics of each of them for the assignment to specific devices and the allocation of resources. 
Type Code Assignment of codes to the 
device Relevance for allocation of 
conformity assessment team 
MDA / MDN Codes reflect design and 
intended  purpose of 
device Exactly 1 code per device. 
 
The codes should be selected 
according to their hierarchical order in Regulation 2017/2185. If more than 1 MDA/ MDN code is applicable, the one that is highest in the list should be selected.  Allocation of personnel involved in 
the review of technical 
documentation (e.g. product 
reviewers) or in audits concerning product related aspects. 
MDS Horizontal codes that 
reflect the specific 
characteristics of the device  0 to several per device 
 
Assign all codes applicable to the 
device.  Select once an MDN/MDA code has been assigned.  Allocation of personnel involved in 
the review of technical 
documentation (e.g. product 
reviewers of sterilisation validation).   
May also be applicable to staff 
performing audits concerning  
certain special processes (e.g. 
sterilization).* 
MDT  
Horizontal codes that describe technologies or processes  1 to several per device 
 Assign the codes which describe the main production technologies or processes.  
 
Select once an MDN/MDA code has been assigned. Allocation of personnel involved in 
audits (e.g. site auditors involved in the auditing of metal processing). 
* Note: Assessment of these codes could be performed by Product reviewers or Site auditors depending on their competence  
 
3.1 MDN / MDA-codes 
MDA / MDN-codes reflect the design and intended purpose of the device and hence are mostly 
relevant for the allocation of personnel involved in the review of technical documentation.  In some 
specific cases, the NB may assign product reviewers to assess product performance and safety aspects during an audit. This means that if there are product related issues to be audited and the auditors do not possess the required qualification, product reviewers who are qualified for the device in question should be part of the audit team.  
The NB needs to ensure that the personnel allocated to the project are competent to assess for the 
devices and technologies under assessment . Special attention should be paid in situations such as 
the one described in example 4 of this section.   
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 The MDA / MDN codes may either specify a field of medical application (e.g. MDA 0309 Active non-
implantable ophthalmologic devices) or the physical or technological principle of the device (e.g. MDA 
0302 Active non-implantable devices utilising non-ionizing radiation or MDA 0315 Software). 
Therefore, there are cases where more than one specific code might apply to a device (e.g. surgical 
laser for refractive surgery of the eye ). Also, where there is a broad intended purpose, several codes 
may apply. 
Having these issues in mind, when drafting the Regulation 2017/2185, the codes were put in order 
such that the MDA/MDN codes that require very specific technological knowledge and experience are highest in the code lists. Therefore, in cases where more than one MDA/MDN code apply, the code highest in the list is to be selected. This approach ensures consistent assignment of codes (and therefore consistent assignment of suitably qualified staff) to devices. 
Example 1: A surgical laser for refractive surgery of the eye is assigned to MDA 0302 Active 
non-implantable devices utilising non-ionizing radiation and not to MDA 0309 Active non-
implantable ophthalmologic devices because, even though both codes are specific for the device, since MDA 0302 is higher in the list. 
Example 2: A screw for orthopaedic surgery is assigned to MDN 1102 Non-active osteo- and 
orthopaedic implants and not to 1104 Non-active soft tissue and other implants, because MDN 1102 is higher in the list. 
Devices may be composed of different “components” which, if they were products on their own, would 
belong to different MDA/MDN codes
(1). In such cases, the intended purpose or the main physical or 
technological principle of the device should be considered (Example 3).  Nonetheless, the notified body needs to ensure that the assigned staff is qualified to assess all components of the device.  
Example 3: A medical devices is composed of a suture anchor (a bone screw attached to a 
surgical suture to reattach ruptured tendons) as well as a single use deployment instrument 
and a single use bone drill. The components are provided sterile in a blister, are covered by the same technical documentation and are not available individually (e.g. are not medical devices on their own). This product is assigned to MDN 1102 Non-active osteo- and orthopaedic implants and not to MDN 1208 Non-active non-implantable instruments because the implanted component of the device is associated with the intended purpose rather than the deployment instrument and the drill.  
Note that, given the complexity and the diversity of medical devices, in exceptional cases deviations 
from the guidance given above may be necessary when assigning codes to devices in order to ensure 
suitably qualified staff in the conformity assessment. In such cases, a brief rationale shall be documented (see Example 4).  
Example 4: A heater-cooler unit (HCU) for cardiac surgery is a device through which blood 
circulates, and which changes the circulating blood’s temperature in order to achieve hypo- or hyperthermia. Both the codes MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia and MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis are specific to the 
device. Since MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia is 
a code that describes physical or technological characteristics higher in the list, according to the rule explained above MDA 0303 should be chosen. Nonetheless, the notified body assigns the device to the code MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis and documents that 
the risks associated with the HCU are such that the staff having experience in this code is 
more suitable to assess the device.  
It is important to note that Stand-alone software (i.e. software that is not part of a physical medical 
device) should be assigned to MDA 0315 since assessment of software requires very specific knowledge (see annex VII 3.2.2 5
th indent MDR) and also that  non-implantable cardiovascular 
                                            
1 This description does NOT refer to procedure packs or systems according to MDR Article 2 (10) and (11) since those are 
combinations of individual CE-marked products that have been subjected to separate conformity assessments.  
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 catheters, guidewires, introducers, filters and related tools shall fall under MDN 1203 (instead of MDN 
1201 or MDN 1202). 
 
3.2 MDS codes 
MDS codes are horizontal codes that are applicable to devices with specific characteristics. All codes 
that are applicable need to be assigned to a device in order to ensure that the review team possesses 
the full set of qualifications necessary for the conformity assessment. The MDS-codes are mainly relevant for the allocation of personnel involved in the review of technical documentation. This is because, generally, the auditing aspects linked to MDS codes have their corresponding MDT code for 
the relevant technology (e.g. MDS 1001 Devices incorporating medicinal substances  vs MDT 2007  
Devices which require knowledge regarding the production of pha rmaceuticals ). However, MDS 
codes may also be applicable to staff performing audits concerning  certain special processes (for 
example MDS 1005 for staff auditing ethylene oxide sterilization processes). 
Example 1: A partially resorbable, sterile surgical implant that contains an antibiotic to prevent 
post-surgical infection will need to be assigned to the following MDS codes:  
1) MDS 1005 - Devices in sterile condition: because it is provided sterile,  
2) MDS 1008 - Devices utilising [...] being wholly or mainly absorbed or locally dispersed 
in the human body […]:  because it is absorbed, and  
3) MDS 1001 - Devices incorporating medicinal substances: because it contains an 
antibiotic. 
Example 2: An infusion pump should be assigned to MDS 1009 - Devices incorporating 
software/utilising software/controlled by software […] because the infusion pump is controlled 
by software. 
3.3 MDT codes 
MDT codes relate to the technologies and processes that are used in the manufacturing and making available of the devices. MDT codes are relevant for the allocation of site auditors. 
Assignment of MDT codes should be done taking into consideration production of the device itself as 
well as for critical upstream production steps. This means that, even  though many codes could be 
applicable when taking into consideration the processes involved in the entire supply chain of a medical device, these should not be considered for the use of MDT codes (e.g. for an electronic 
medical thermometer, at one point, metal processing, plastic processing, non-metal mineral processing, chemical processing, manufacture in clean rooms, manufacturing using electronic components, labelling and packaging are necessary to assemble the device from raw materials).  
Example 1: An electronic medical thermometer for layman’s use should be assigned to the 
following MDT codes:  
1) MDT 2010 Devices manufactured using electronic components including 
communication devices because the product is assembled from electronic 
components and  
2) MDT 2011 Devices which require packaging, including labelling because the device is 
packed and labelled. 
Example 2: A sterile animal derived bone graft substitute is manufactured using several steps. 
In the first step, the raw animal bone undergoes a sequence of chemical treatments to remove organic components. In a second step, the remaining mineral bone component is subjected to a heat treatment, then ground and sieved to obtain particles of defined sizes. The material is packed, labelled and sterilized. Therefore the following MDT codes should be assigned:  
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 1) MDT 2008 Devices manufactured in clean rooms and associated controlled 
environments, because the manufacturing of the implant after the heat treatment is conducted in clean rooms,  
2) MDT 2009 Devices manufactured using processing of materials of human, animal, or 
microbial origin because the implant is made from animal bone 
3) MDT 2011 Devices which require packaging, including labelling because the implant 
is packed and labelled. 
Note: MDT 2006 Devices manufactured using chemical processing and MDT 2003 
Devices manufactured using non-metal mineral processing (e.g. glass, ceramics) 
were not applied since the chemical treatment and (bone) mineral processing are already considered within the scope of processing of animal materials.  
Example 3: A calcium phosphate bone cement is provided as a sterile powder composed of a 
mixture of calcium salts and a vial with sterile saline.  The following MDT codes should be assigned: 
1) MDT 2008 Devices manufactured in clean rooms and associated controlled 
environments, because the manufacturing of the implant is in a controlled environment,  
2) MDT 2006 Devices manufactured using chemical processing, because the main risks 
in manufacturing are related to the testing and mixing of the components, 
3) MDT 2011 Devices which require packaging, including labelling because the implant 
is packed and labelled. 
Example 4: A manufacturer of cross-linked hyaluronic acid implants has no in-house 
manufacturing. The finished, labelled implant is bought from a supplier. The implant raw 
material (hyaluronic acid) is produced by fermentation using bacteria. The following MDT 
codes should be assigned: 
1) MDT 2008 Devices manufactured in clean rooms and associated controlled 
environments, because the manufacturing of the implant is in a controlled environment,  
2) MDT 2005 Devices manufactured using bi otechnology, because the main risks in 
manufacturing are related to the production and cross-linking of the hyaluronic acid. 
3) MDT 2011 Devices which require packaging, including labelling because the implant 
is packed and labelled. 
Note that, despite the fact that the manufacturer itself does not physically manufacture the 
device, the MDT codes concerning the manufacturing steps are assigned to the device since they are relevant when auditing suppliers / subcontractors. 
4 Competence description: conditions (including limitations) 
Conditions should be established by the notified body for individual codes in cases where the qualification of the staff authorised to a certain code is not sufficient to cover the entire spectrum of the devices within this code.  The designating authority could also apply conditions to the notified 
body's designation where the notified body does not have sufficient competence to cover a given 
code or could seek designation for conformity assessment of only certain devices within a code. 
Conditions, including limitations, should be formulated in an unambiguous way (see example 1). 
Furthermore, since the technical codes basically mirror the competence system of the notified body, the conditions and limitations should concern device characteristics (see example 2). 
Example 1: “MDN 1101 Non-active cardiovascular, vascular and neurovascular implants. 
Condition: heart valves”. This condition is unsuitable since it is not clear whether the notified body is restricted to assessment of heart valves or whether those products are excluded from  
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 the scope of designation. Therefore, the condition should be “excluding heart valves” or 
“including only heart valves”. 
Example 2: “MDN 1102 Non-active osteo- and orthopaedic implants. Condition: excluding 
class III devices”. The scope of designation is intimately linked to the qualification of the staff 
that the notified body needs to have available. Conditions serve to exclude the devices for 
which the notified body does not have competent staff and/or suitable procedures; therefore, they need to be expressed in a way that they relate to knowledge and experience of staff and/or procedures. The condition “excluding class III devices” does not allow this and therefore it is unsuitable. In this case, the designating authority has to determine, based on the qualification of the notified body’s staff, which devices are included in the scope. This 
might result, for example, in the following condition: “including only orthopaedic plates and 
screws; excluding implants that are applied in or on the spine”. 
Further examples of conditions are illustrated in the final column of the table below. Considerations of 
the conditions should be based on the demonstrated competence of the applicant body
. 
   
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5 Specific clarifications linked to individual codes  
The devices included in the third and fourth columns are only a few examples of the devices covered in the relevant code. The t hird 
column is not intended to provide an exhaustive list of devices included in each code. 
 
MDA 
CODE Active implantable devices Devices covered and Specific 
Considerations1 Examples of 
conditions 
MDA 0101 Active implantable devices for stimulation / inhibition / monitoring Implanted defibrillator 
Spinal cord stimulator 
Implantable cardiac pacemakers 
Implantable bladder stimulators Excluding brain stimulation 
MDA 0102 
 Active implantable devices delivering drugs or other substances Implanted drug delivery pump 
  
MDA 0103  Active implantable devices supporting or replacing organ functions Artificial heart 
Cochlear implants 
 
  
MDA 0104 
 Active implantable devices utilising radiation and other active implantable 
devices Prostate radioactive seed implant 
 
  
  
                                            
1 The assessment also should consider Section 5.1 of Annex IX applies as well as Validation of SSCP acc. Article 32 .   
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 MDA 
CODE Active non-implantable devices for imaging, monitoring and / or 
diagnosis Devices covered and Specific 
Considerations Examples of conditions 
MDA 0201 
 Active non-implantable imaging devices utilising ionizing radiation X-ray computer tomography equipment  
Gamma cameras 
Fluoroscopy equipment 
PET scanner Restricted to X-ray and gamma 
cameras 
MDA 0202  Active non-implantable imaging devices utilising non-ionizing radiation MRI computer tomograph 
  
MDA 0203 
 Active non-implantable devices for monitoring of vital physiological 
parameters Blood pressure monitor 
Medical thermometer 
Pulse oximeter 
Apnoea monitors  
Intensive care patient monitoring system 
Spirometers 
Electrocardiographs 
Electroencephalographs 
  
MDA 0204 
 Other active non-implantable devices for monitoring and / or diagnosis Ocular tonometer 
Audiometers 
Retinal cameras  
   
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 MDA 
CODE Active non-implantable therapeutic devices and general active 
non-implantable devices Devices covered and Specific 
Considerations Examples of conditions 
MDA 0301 
 Active non-implantable devices utilising ionizing radiation 
 Radioactive sources for cancer after 
loading therapy 
Therapeutic cyclotrons and linear 
accelerators   
MDA 0302 
 Active non-implantable devices utilising non-ionizing radiation Surgical laser for refractive surgery of the 
eye 
Laser for pain treatment 
 
 Including only microwave and 
magnetotherapy medical devices 
MDA 0303  Active non-implantable devices utilising hyperthermia / hypothermia Medical heating blanket 
 
Warming and cooling blankets 
Blood warmers 
Paraffin bath  
MDA 0304  Active non-implantable devices for shock-wave therapy (lithotripsy) Extracorporeal shock wave lithotripsy 
device 
 
  
MDA 0305  Active non-implantable devices for stimulation or inhibition 
 Automated external defibrillator 
Device for the transcranial magnetic brain 
stimulation 
Device for transcutaneous electrical nerve 
stimulation (TENS) 
Muscle stimulators 
Electrical acupuncture 
External bone growth stimulators 
  
   
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 MDA 
0306 
 Active non-implantable devices for extra- corporal circulation, administration or 
removal of substances and haemapheresis Haemodialysis machine and equipment 
Cardiopulmonary bypass pump 
Infusion pumps 
Feeding pumps 
Jet injectors for vaccination 
Blood pumps for heart-lung machines 
Anaesthesia machines  
MDA 
0307 
 Active non-implantable respiratory devices 
 Medical ventilator 
Hyperbaric chambers 
Nebulisers  
MDA 
0308 
 Active non-implantable devices for wound and skin care 
 Water jet for wound debridement 
  
MDA 
0309 
 Active non-implantable ophthalmologic devices 
 Aspiration pump for opthalmological use 
(removal of crystalline residue)  
MDA 
0310 
 Active non-implantable devices for ear, nose and throat  
 Hearing aids 
 
MDA 
0311 
 Active non-implantable dental devices 
 Powered dental surgical unit and hand 
pieces 
Surgical suction device for dental use 
Ultrasonic scalers  
Chairs with equipment 
  
MDA 
0312 
 Other active non-implantable surgical devices 
 RF electrosurgical generator 
Electrosurgical instrument Cauterization 
devices. 
Powered surgical drills and saws    
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 MDA 
0313 
 Active non-implantable prostheses, devices for rehabilitation and devices for 
patient positioning and transport  Hospital beds 
Patient hoists 
Electric Wheelchairs 
Active limb prostheses 
Exoskeletons  
MDA 
0314 
 Active non-implantable devices for processing and preservation of human cells, 
tissues or organs including in vitro fertilisation (IVF) and assisted reproductive 
technologies (ART) IVF cryopreservation systems 
blood bank refrigerator  
MDA 
0315 
 Software  
 Radiotherapy planning system. 
 
MDA 
0316 
 Medical gas supply systems and parts thereof 
 Medical gas supply system in a hospital 
Gas manifold and line pressure regulator 
for medical regulators 
Medical gas supply pipeline systems   
MDA 
0317 
 Active non-implantable devices for cleaning, disinfection and sterilisation Sterilizers like autoclaves etc 
Washer disinfector for medical devices.  
MDA 
0318 
 Other active non-implantable devices 
  
 
   
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 MDN 
CODE Non-active implants and long term surgically invasive devices Devices covered and Specific 
Considerations Examples of conditions 
MDN 
1101 
 Non-active cardiovascular, vascular and neurovascular implants Cardiac vascular stent 
Peripheral vascular stent 
Artificial heart valve 
Cardiac Valve Prostheses, Vascular and 
neurovascular grafts, shunts, vascular 
stents, cardiovascular patches 
Sutures for cardiovascular surgery 
For biological heart valves MDS 1003 
should be applied. For drug eluting stents - 
MDS 1001 should be appliedIncluding only cardiac stents 
MDN 
1102 
 Non-active osteo- and orthopaedic implants 
 Artificial spinal disc 
Spinal cage 
Bone graft substitute for orthopaedic 
indications 
Prosthetic joint replacements (i.e knee, hip 
implants) 
Bone cement 
Hyaluronic acid implant for intra-articular 
use 
Orthopaedic nails, screws,plates 
Bone graft substitute for maxillofacial 
indications 
sutures, suture anchors, staples for 
orthopedic surgery 
spacers, ligament reconstruction products 
 
For antibiotic bone cements- MDS 1001 
should be applied 
For absorbable substances MDS 1008 
should be applied   
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 MDN 
1103 
 Non-active dental implants and dental materials 
 Dental implant  
Dental fillers 
Root canal filler 
Abutments   
   
15 
 MDN 
1104 
 Non-active soft tissue and other implants 
 Hyaluronic acid dermal fillers 
Intraocular lenses 
Intrauterine dispositive- IUD 
Breast implant 
Hernia mesh 
Urethral stent implants 
Sutures (not falling within the above codes) 
Eyelid implants 
 
Bariatric surgery devices: Intragastric 
Balloons, Gastric Bands, Anti-Reflux 
implants. 
Lung Volume Reduction devices: Coils, 
Valves, Sealants. Biliary and Pancreatic 
stents 
 
For contraceptive intrauterine devices 
containing copper or silver – MDS 1001 
should be applied 
 Excluding breast implants 
MDN 
CODE Non-active non-implantable devices Devices covered  and specific 
conditions Examples of conditions 
MDN 
1201 
 Non-active non-implantable devices for anaesthesia, emergency and intensive 
care Device for pleural drainage 
Masks, tubes for the administration of 
gases. 
Endotracheal tube 
Tracheostomy tubes Endotracheal tube 
introducers   
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 MDN 
1202 
 Non-active non-implantable devices for administration, channelling and removal 
of substances, including devices for dialysis Intravenous line 
Hypodermic needle 
Syringe tubing, bags for injection or 
transfusion 
Dialysis filter 
Dialysis solution 
Epidural catheters, Urinary Catheter 
Amnioscopic needles  
 
MDN 
1203 
 Non-active non-implantable guide catheters, balloon catheters, guidewires, 
introducers, filters, and related tools Vascular filter catheter 
Embolectomy catheter  
Cardiovascular guidewires and catheters 
Neurovascular catheters 
central venous catheter.  
MDN 
1204 
 Non-active non-implantable devices for wound and skin care 
 Wound dressing 
Cotton wool 
Gauze dressings 
Bandages 
Sutures for dermal wound closure (of less 
than 30 days) 
Surgical gloves 
For dressings incorporating an 
antimicrobial agent -  MDS 1001 should be 
applied 
MDN 
1205 
 Non-active non-implantable orthopaedic and rehabilitation devices Orthoses 
Crutches 
Wheelchairs   
17 
 MDN 
1206 
 Non-active non-implantable ophthalmologic devices 
 Contact lenses 
Eye drops 
Instrument for ophthalmologic surgery 
Solutions for contact lenses.  
MDN 
1207 
 Non-active non-implantable diagnostic devices  Thermal expansion thermometer  
MDN 
1208 
 Non-active non-implantable instruments 
 Instruments for general use in surgery: 
Forceps, clamps, scalpels, dental 
instruments 
  
MDN 
1209 
 Non-active non-implantable dental materials 
 Etching solution for dental use 
Braces 
Dental cements (when not considered long 
term surgically invasive) 
Dental impression materials  
MDN 
1210 
 Non-active non-implantable devices used for contraception or prevention of the 
transmission of sexually transmitted diseases Condom 
Contraceptive diaphragms  
MDN 
1211 
 Non-active non-implantable devices for disinfecting, cleaning and rinsing Solutions for disinfecting medical devices  
Contact lens care, catheter lock solutions 
  
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) Freezing solution for egg cells 
Embryo transfer catheters 
Artificial insemination probes 
Media, substances or mixture of 
substances intended for washing, 
separating, sperm immobilizing, 
cryoprotecting solutions. 
   
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 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   
MDN 
1214 
 General non-active non-implantable devices used in health care and other non-
active non-implantable devices Ultrasound gels   
   
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 MDS 
CODE Devices with specific characteristics Devices covered  and specific 
conditions Examples of conditions 
MDS 
1001 
 Devices incorporating medicinal substances 
 Devices incorporating medicinal products 
including herbal substances and human 
blood derivatives are included in this code.   
MDS 
1002 
 Devices manufactured utilising tissues or cells of human origin, or their 
derivatives Section 5.3.1 of Annex IX applies   
MDS 
1003 
 Devices manufactured utilising tissues or cells of animal origin, or their 
derivatives Section 5.3.2 of Annex IX applies 
Devices manufactured utilising tissues or 
cells of animal origin, or their derivatives, 
which are non- viable or rendered non-
viable, unless such devices are intended to 
come into contact with intact skin only   
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 Council1   
MDS 
1005 
 Devices in sterile condition  Including aseptic processing, 
ethylene oxide gas sterilisation 
(EOG), low temperature steam, 
formaldehyde sterilisation, moist 
heat sterilisation, radiation (gamma, 
x-ray, electron beam), sterilisation 
with hydrogen peroxide, sterilisation 
with liquid chemical sterilising 
agents, thermic sterilisation with dry 
heat 
                                            
1 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/E C (recast) (OJ L 157 
9.6.2006, p. 24).  
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 MDS 
1006 
 Reusable surgical instruments 
 Reusable surgical instruments according to 
art. 52 (7) c) MDR   
MDS 
1007 
 Devices incorporating or consisting of nanomaterial  
   
MDS 
CODE Devices with specific characteristics Devices covered  and specific 
conditions Examples of conditions 
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 Section 5.4 of Annex IX applies for devices  
intended to be introduced into the human 
body via a body orifice or applied to the 
skin and devices  at are systemically 
absorbed by the human body in order to 
achieve their intended purpose   
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    
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 MDS 
1013 
 Class III custom-made implantable devices  
   
MDS 
1014 
 Devices incorporating as an integral part an in vitro  diagnostic device 
   
   
22 
 MDT 
CODE Devices for which specific technologies or processes are used Examples of device manufacturing technologies 
MDT 
2001 Devices manufactured using metal processing 
 3 d printing, Casting, Welding 
3d printing (metal), turning (metal), anodization, passivation, polishing, surface 
modification, laser tube cutting, honing 
MDT 
2002 Devices manufactured using plastic processing 
 Injection molding, Extrusion, Bonding 
polymer compounding, 3d printing (plastics), thermoforming, blow moulding, turning 
(plastics) 
 
MDT 
2003 Devices manufactured using non-metal mineral processing (e.g. glass, 
ceramics) Ceramic sintering, ceramic compounding,  
 
MDT 
2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, 
rubber, leather, paper) Weaving, knitting  
MDT 
2005 Devices manufactured using biotechnology 
 Fermentation using cell cultures, enzymatic production processes, purification and 
modification of biomolecules  
MDT 
2006 Devices manufactured using chemical processing  
 Compounding, buffering  
MDT 
2007 Devices which require knowledge regarding the production of pharmaceuticals production, handling and incorporation into a device of substances which, if used 
separately, can be considered to be a medicinal product  
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 Handling, dissection, storage, processing, inactivation and sterilization of human 
and animal tissues   
 
MDT 
2010 Devices manufactured using electronic components including communication 
devices  
MDT 
2011 Devices which require packaging, including labelling 
   
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 MDT 
2012 Devices which require installation, refurbishment 
 Installation of devices at the point of use by or under the manufacturer’s 
responsibility  
MDT 
2013 Devices which have undergone reprocessing