Can I appoint two different representatives for devices in the same generic group?
No. Under the MDR and MDCG guidance, a manufacturer cannot appoint different authorized representatives for devices that belong to the same generic device group.
But what exactly does “same generic group” mean?
And how does this apply differently under the MDR and the IVDR?
The definition: what do the regulations say?
The term generic device group is defined in the MDR (and also adopted in the Swiss MedDO and IvDO) as:
“a set of devices having the same or similar intended purpose or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics.”
To apply this definition correctly, you need to refer to the EMDN — the European Medical Device Nomenclature — as clarified in MDCG 2019-13.
MDR vs IVDR: different EMDN levels
To correctly identify a generic device group, the relevant EMDN level differs depending on the regulation:
Under MDR:
The generic device group corresponds to the 4th level of the EMDN
(Format: one letter + 6 digits → e.g., A123456)
Under IVDR:
It refers to the 3rd level of the EMDN
(Format: one letter + 4 digits → e.g., A1234)
and must be used together with the IVP code (Intended Purpose)
Need a refresher on how the EMDN works?
We covered it here: What is the EMDN and why does it matter for your medical device?
This means that two similar devices — even with slightly different features — may fall under the same generic group if they share a code at the relevant EMDN level. In such cases, appointing multiple representatives is not allowed.
So, what should you keep in mind?
If two of your devices fall under the same generic group, you are not allowed to assign them to different representatives.
To get this right, you’ll need to determine the appropriate level of the EMDN based on the regulation:
- For MDR, look at the 4th level
- For IVDR, refer to the 3rd level and include the Intended Purpose (IVP)
This distinction is essential to maintain a consistent, compliant, and traceable representation strategy.
Need support with classification or representation strategy?
Get in touch to ensure your documentation, registration, and market access plans are fully aligned with MDR and IVDR requirements.
