Notified body scope · assessment competence · MDR
Understanding MDA, MDN, MDS and MDT codes under the MDR
These codes do not determine whether a device is Class I, IIa, IIb or III. They describe the expertise and designation scope needed for its conformity assessment.
See how the code system works ↓Codes combine to define the competence required
The central distinction
Risk class tells you the regulatory route. MDR codes help identify who is competent to assess it.
A Class IIa, IIb or III classification is determined under Annex VIII of the MDR. MDA, MDN, MDS and MDT codes serve a different purpose. They define the scope of notified body designation and support the allocation of appropriately qualified reviewers and auditors.
01
What the codes are for
Commission Implementing Regulation (EU) 2017/2185 establishes code families that are used to specify the scope of designation of notified bodies. The same codes also help notified bodies describe staff qualifications and identify the competence required for a particular conformity assessment.
For medical devices under the MDR, the system is multidimensional. One code describes the device’s design and intended purpose. Additional horizontal codes capture characteristics and production technologies that require further specialist knowledge.
Designation scope
The codes show which types of devices and technologies a notified body is designated to assess.
Application review
They help the notified body confirm that the device falls within its authorised scope.
Personnel allocation
They support the selection of reviewers and auditors with suitable knowledge and experience.
MDR codes are not the same as the risk-classification rules in Annex VIII and are not the same as EMDN nomenclature codes used to identify device categories in EUDAMED.
02
MDA and MDN codes
MDA and MDN codes reflect the design and intended purpose of the device. MDA codes cover active devices, while MDN codes cover non-active devices. They may describe a medical field, a physical principle or a particular technological characteristic.
These codes are mainly relevant when selecting personnel to review technical documentation and product-related aspects of an assessment.
Active devices
MDA
- MDA 0101 Active implantable devices for stimulation, inhibition or monitoring
- MDA 0201 Active non-implantable imaging devices using ionising radiation
- MDA 0306 Active devices for extracorporeal circulation or administration and removal of substances
- MDA 0315 Software
Non-active devices
MDN
- MDN 1102 Non-active osteo- and orthopaedic implants
- MDN 1203 Guide catheters, balloon catheters, guidewires and related tools
- MDN 1210 Devices used for contraception or prevention of sexually transmitted diseases
How the primary code is selected
Each device is normally assigned exactly one MDA or MDN code. A device may initially appear to fit more than one code because the list contains codes based on both medical application and technological principle.
Where several codes appear applicable, MDCG 2019-14 generally directs the user to select the applicable code highest in the list. The ordering gives priority to codes requiring more specific technological knowledge. The device’s intended purpose and principal physical or technological characteristics still need to be considered.
In exceptional cases, a different code may be more appropriate to ensure that suitably qualified personnel are assigned. The notified body should document the rationale for such a departure.
Standalone medical device software is assigned MDA 0315. Software that is incorporated into or controls a physical device does not replace that device’s primary MDA or MDN code. Instead, the software characteristic is normally captured through MDS 1009.
03
MDS codes
MDS codes are horizontal codes describing specific device characteristics. A device may have no MDS code, one MDS code or several. Every applicable MDS code should be assigned after the MDA or MDN code has been identified.
They are mainly used to ensure that the technical-documentation review team has the specialist knowledge needed for characteristics such as sterility, incorporated medicinal substances, software, nanomaterials or a measuring function. Some MDS codes may also be relevant to audit personnel reviewing a special process.
Devices incorporating medicinal substances
Devices in sterile condition
Devices incorporating or consisting of nanomaterial
Devices incorporating, using or controlled by software
Devices with a measuring function
Devices in systems or procedure packs
A sterile, partially absorbable implant containing an antibiotic may require MDS 1005 for sterility, MDS 1008 for absorption or local dispersion, and MDS 1001 for the incorporated medicinal substance.
04
MDT codes
MDT codes describe technologies and processes used to manufacture and make devices available. They are principally relevant to the allocation of qualified site auditors.
A device is normally assigned one or more MDT codes. The assessment should cover production of the device itself and relevant critical upstream production steps, but it should not automatically extend every code across the entire supply chain.
Metal processing
Biotechnology
Clean rooms and associated controlled environments
Processing materials of human, animal or microbial origin
Electronic components, including communication devices
Packaging, including labelling
What happens when manufacturing is outsourced
An outsourced process does not become irrelevant merely because it is performed by a supplier. Critical upstream processes should still be reflected in the competence needed for the assessment. Whether the notified body audits a particular supplier or subcontractor depends on the significance of the activity, the associated risks and the manufacturer’s controls over the outsourced process.
05
How the codes are assigned
The manufacturer normally proposes the relevant codes when applying to a notified body. The notified body then checks whether the proposed code set is correct, whether the device falls within its designation scope and whether it has access to appropriately qualified personnel.
If the proposed codes are incomplete or incorrect, the notified body may correct or reassign them. The final code profile should reflect the device, its intended purpose, relevant characteristics and the manufacturing processes that require assessment competence.
Identifies the device and proposes the applicable codes in the application.
Verifies the code set and confirms that the device is within its designation scope.
Reviewers and auditors are selected with competence covering the complete device profile.
Correct code identification can help avoid a late discovery that a notified body lacks the necessary designation scope or qualified personnel. It does not, however, change the device’s risk class or replace the manufacturer’s regulatory analysis.
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Example of an infusion pump
Consider a software-controlled infusion pump with a measuring function and electronic components. Its code profile could include the following codes.
Its primary purpose includes the administration of substances.
It is controlled by software.
It has a measuring function.
Electronic components are used in its manufacture.
Other MDT codes may also be applicable. MDT 2011 may be relevant to packaging and labelling, while MDT 2008 may be relevant where production takes place in a clean room or associated controlled environment. The final selection depends on the actual product and manufacturing arrangements.
07
What changes under the IVDR
MDA, MDN, MDS and MDT are the code families used for medical devices under the MDR. In vitro diagnostic medical devices use a separate set of codes in Annex II of Commission Implementing Regulation (EU) 2017/2185.
Design and intended purpose of the IVD
Specific characteristics of the IVD
Technologies used to manufacture the IVD
Examination procedures requiring specific knowledge
The logic is similar because the codes describe notified body scope and personnel competence. The actual code families and assignment rules are different, however, and should be assessed using the IVDR list and MDCG 2021-14.
In practical terms
Build a complete assessment profile, not another device classification
The MDA or MDN code identifies the device’s principal design and intended-purpose category. MDS codes add relevant special characteristics, while MDT codes identify manufacturing technologies and processes requiring suitable audit competence.
Together, these codes help determine whether a notified body can accept the application and which specialists should participate in the conformity assessment. They support device assessment, but they do not determine the MDR risk class and do not replace EMDN nomenclature.
Official references
Preparing a notified body application?
Confirm the designation scope before the assessment begins
MDRC helps manufacturers define the regulatory pathway, identify the applicable code profile and prepare technical documentation for notified body assessment.
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