The MDR and IVDR use the terms generic device groups and device category without fully defining them.
For manufacturers and notified bodies, it is important to understand what a generic device group is and what device categories are. It's the only way both can prepare for audits and the evaluation of technical documentation.
But take care: The division of devices into device groups and device categories not only affects the “sampling” of these devices.
The EU Medical Device Regulation MDR does define the term generic device group. But it does not define what a device category is. The “Guidance Document“ MDCG 2019-13 gives us more clarity, thankfully.
The MDR defines a “generic device group” as follows:
“A “generic device group” describes a group of devices with the same or similar intended uses or with technological similarities that can be classified even without considering specific features;”
Source: MDR Article 2(7)
This definition would certainly lead to consistent discussion about the correct classification. Therefore, it is welcome that the Medical Device Coordination Group MDCG wants the generic device group to be understood…
„as the 4th level of the European Nomenclature on Medical Devices (EMDN) (i.e. combination of one letter plus 6 digits) [in respect of the MDR], and in respect of the IVDR as the 3rd level of the EMDN (i.e. combination of one letter plus 4 digits respectively) in combination with the most appropriate IVP code.”
For example, blood pressure monitoring devices are not a generic device group (see fig. 2), because there are already to be put on the 5th level. They are part of the generic device group “Vital Signs Monitoring Instruments”.
The CND/EMDN system includes 1681 codes on the fourth level - ergo 1681 generic device groups.
ISO 13485:2016 lists the term for “medical device group”:
“Group of medical devices manufactured by or for the same organization, and which have the same basic design and performance features regarding safety, proper use and mode of action”
Source: DIN EN IS= 13485:2016-08 (3.12)
The term “medical device group” is narrower than the general device groups pursuant to MDR, because it only summarizes devices with the same intended use.
ISO 13485 makes it possible for manufacturers to create common technical documentation for a medical device group. The MDR and MDCG does not see the generic device group as the feature, but the Base UDI-DI.
The MDR does not have the definition of device category. According to the MDCG, the “codes and the corresponding device types” according to the EU Implementation Directive (EU) 2017/2185 are meant:
“category of devices should be understood as the relevant MDA/MDN codes (MDR) or IVR codes (IVDR) according to Regulation (EU) 2017/2185 on the codes for the designation of notified bodies.”
Source: EU 2017/2185
This directive differentiates between 71 codes for the devices regulated by the MDR and 79 codes for IVD devices. These categories divide the medical devices into larger classes than the device groups (see also fig. 1).
The MDCG introduces another term with “Device Range”:
“Device range is to be understood as all “device categories“ for Class IIa and Class B devices and all “generic device groups” for Class IIb and Class C devices covered in a certificate.“
Source: MCDG 2019-13
This means that Device Range is an umbrella term, which defines a device category (class IIa) and the generic device group (class IIb) depending on the class of the device.
Read more here on the subject of codes, in particular the UMDNS, GMND, CND / EMDN Codes. With Download!
The division of devices into device groups and device categories is relevant to the sampling, meaning the selection of samples for QM audits and the assessment of the technical documentation:
However, according to MDCG 2019-13, there are limitations and exceptions to these rules:
Sampling also applies to the planned audits as well as to unplanned ones:
Within the framework of unannounced on-site audits, the notified body will test an appropriate sample of the device produced or an appropriate sample from the production process, to determine whether the device produced is consistent with the technical documentation, with the exception of the devices listed in article 52 (8) (2).
MDR Annex IX 3.4
How the devices are divided into groups and categories not only has an effect on audits and reviews of technical documentation:
You may think, finally there is some clarity. It is finally clear how devices are very concretely divided into device categories and then into generic device classes. But it's just not that easy:
The rules for classification of medical devices into categories and groups have apparently been created by various working groups. The result is, that no consistent taxonomy has been created: The codes of the EU Commission for the device categories are not(!) stringently consistent with the higher levels of the CND/EMDN classification.
As soon as manufacturers or notified bodies have to decide to which device category a generic device group belongs, discussion is pre-programmed. It is now time for our authorities to consider a standardization of the standardization.
But let's look at the good thing: We now have two classification systems for the sampling of devices, that compensate for the deficit of lacking or inexact definitions of the terms device category and generic device group.