The Medical Device Regulation codes, or MDR codes for short, specify what the notified bodies are designated for and thereby stipulate what category of devices the notified bodies can work with.

The following video explains them in-depth, and it is a part of our online course Introduction to the Medical Device Regulation (MDR) 2017/745.

This article will deal with those MDR codes, but also the EMDN codes which are the device-related codes needed under the MDR. They are also related to the notified bodies for class IIb devices, and all manufacturers need to be aware of them because they are used when reporting to EUDAMED for all classes of devices.

Essentially, every manufacturer shall assign the MDR codes to their devices when applying for conformity assessment to a notified body.

MDR codes for notified bodies

The Medical Device Regulation codes for notified bodies are published in the Implementing Regulation, 2017/2185, which means that they cannot be found in the MDR.

The MDR codes are divided into four categories.

First, there are the MDA and MDN codes that relate to the design and intended purpose of the device. MDA codes are for active medical devices, and MDN for non-active devices.

Then, there are the so-called horizontal codes. They are also divided into two categories – one for specific characteristics of the medical device, the MDS codes, and the other ones are for specific technology or processes related to the manufacturing of the medical device, the MDT codes.

Medical device code categories

When it comes to MDA and MDN codes, the manufacturer and the notified body need to agree on only one applicable product code for each device, MDN or MDA.

For the specific characteristics codes, the MDS, it could be that no code applies, or it could be that several codes apply, depending on the characteristics of the device.

When it comes to the technologies codes, the MDT, at least one code needs to be specified, but for the MDT code, there could also be several applicable codes.

So, when a manufacturer applies to a notified body, they need to specify which of these MDR codes apply to each of their devices. This is done so the notified body can decide if they are designated to be able to work with those devices.

The MDA and MDN codes are then further divided to form three active sub-groups for MDA, and two non-active sub-groups for MDN.

The first MDA group of codes is active implantable devices and this is where active implantable medical devices are to be found, with the four categories of devices.

Then, there is the group of active non-implantable devices for imaging, monitoring, and/or diagnosis with its four categories.

The third group under MDA is active non-implantable therapeutic devices and general active non-implantable devices. This sub-group has 18 categories.

When it comes to the non-active codes, the MDN codes and their two sub-groups, the MDN codes start with the group for non-active implants and long-term surgically invasive devices. The other MDN group is non-active non-implantable devices and it has 14 categories in it.

It should be added that the MDA and the MDN codes are used to group class IIa devices when the notified body decides on the sampling of the technical documentation during conformity assessment. So, for initial notified body certification, the notified body will choose at least one sample of class IIa products from each MDA and/or MDN category.

Therefore, the manufacturer needs to find one applicable MDA or MDN code for each device. In other words, for each medical device, only one MDA or MDN code should be assigned. But again, when it comes to the horizontal codes, none or more codes could be applicable for each device.

 

The horizontal MDR codes

The horizontal codes are divided into two groups; MDS and MDT. These horizontal codes start with devices with specific characteristics, the MDS codes. There are 14 codes for those specific characteristics.

The other horizontal codes are the MDT codes and those are called devices for which specific technologies or processes are used. At least one of these MDT codes per device must be applied, and there are 13 of them. In their essence, they specify how the devices are manufactured.

To clarify the MDR coding system a bit there is an MDCG endorsed document published related to these codes. This MDCG endorsed document is the MDCG 2019-14, and is named ”Explanatory note on MDR codes”. It explains the coding a bit and also includes some helpful examples of devices for each code.

EMDN codes

The other coding system in the MDR is called EMDN, which is short for European Medical Device Nomenclature, and it is stipulated in Article 26 in the MDR that there must be a specific nomenclature set up in the EU for identifying different types of devices.

When the commission had to decide on what system to use for this nomenclature, the choice fell on the Italian CND system, which has been functional for device registration in Italy, Portugal, and Greece for quite a while under the previous Medical Device Directive.

The main purpose of the EMDN codes is to facilitate the function of EUDAMED, but also to facilitate the grouping of class IIb devices, when the notified body decides the extent of sampling of technical documentation needed for conformity assessment.

On the European commission website for MDCG documents, several documents related to EMDN codes for more detailed information on this coding system can be found.

There is a specific one you might want to look at: MDCG 2021-12 called FAQ on the European Medical Device Nomenclature (EMDN).

The following can be read in this MDCG document:

“EMDN is intended to support all actors in their activities under the MDR. And provides key device descriptions to patients as regards to their own devices and all other devices available on the market and registered in EUDAMED.”

So, there is no doubt that this is important, not only to the manufacturers but also for the patients to identify devices that they use.

 

What are the EMDN codes used for?

A manufacturer needs the EMDN codes when registering devices in EUDAMED, but also when reporting potential incidents in EUDAMED. In addition to this, if a person belongs to the public and knows that they are going to be treated or supplied with some kind of medical device, and wants to see what products are out there and what potential vigilance cases they have, then they can search for the applicable EMDN code and then use that code to look up the products in EUDAMED and find potential alternative devices.

EMDN codes on the web

These EMDN codes can be found on the EMDN website where one can search for specific terms and devices.

There are seven different levels of these EMDN codes, and the MDCG document 2021-12 explains the level structure of EMDN.

The first level defines the categories and continues with level 2, which defines the groups and then a number of different type specifications, 1 to 5. Each alphanumeric code (meaning the actual EMDN code) then begins with a letter referring to the category under which the device falls. This is followed by two numbers indicating the group and a series of numbers that refer to the type. And the more numbers are defined, the more specific the definition of the device will be.

The maximum number of characters for an EMDN code is thereby set to 13, and all EMDN codes start with a letter.

When you need to find the applicable code for a specific type of device, you can visit the EMDN web page and either search directly, in the search field, or browse your way through the different levels.

At level four of EMDN coding, the grouping of class IIb devices is done for the sampling of technical documentation. This is important when applying to a notified body for conformity assessment of class IIb devices. This level constitutes one letter and six digits, and it is what the manufacturer will be asked to define when applying to a notified body, if they have a class IIb device.

One last note – when registering devices in EUDAMED or reporting vigilance, the manufacturer shall assign the most granular and terminal term available, meaning the lowest applicable level of code in the tree structure.

Summary

In summary, the EMDN codes are relevant for EUDAMED for device registration, but also when applying to a notified body if the manufacturer has class IIb devices. On the other hand, the MDR codes are relevant when applying to a notified body, independent of classification but specifically if the manufacturer has class IIa devices, since the MDR codes group those devices for sampling decision of the notified body during their conformity assessment.

If you found this article helpful, you can browse our previously published articles, and maybe you will find something of help and interest.

Would you like to know more about the Medical Device Regulation?

If you want to know more about understanding the European regulation for medical devices, take a look at our online Introduction to the Medical Device Regulation (EU) 2017/745 course. This online course is an in-depth overview of the Medical Device Regulation according to (EU) 2017/745 as well as related guidances, like MDCG, and how to apply to a notified body for conformity assessment.

It is suitable for anyone working with regulatory questions, such as RA and QA engineers, PRRC or management.

Pontus Gedda

Pontus Gedda

Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.

He has vast experience in the MDR and its implementation thru hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.

He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.