Yes. It is possible for manufacturers to switch from one European Authorized Representative (EU AR) to another. While the old Directives do not specify the process to change providers, the new MDR/IVDR does specifically address the requirements to transition to a new provider.
For more information on the role of the EU AR and how Casus can help, please read: European Authorized Representative Overview
Only one EU Authorized Representative (aka EC-REP) may be appointed per device group. This is the same under both the old Directives and the new MDR/IVDR. Meaning, you may appoint more than one EU AR at the same time; however, only if each EU AR represents different products.
For the old Directives, EU guidance MEDDEV 2.5/10 states:
“as clarified in Recital 14 of Directive 2007/47/EC, an authorised representative must be the single authorized representative within EU for at least all devices of the same type. A manufacturer may have different authorized representatives for different devices (types).”
Article 11(2) of the MDR/IVDR states:
“the designation shall constitute the authorised representative’s mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.”
What is a generic device group?
The MDR/IVDR defines it as:
“a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics”
EU guidance document MDCG 2019-13 further clarifies that a generic device group is:
Does that sound complicated? Fortunately, it is not.
Below is an image from the EMDN database. Using ‘needles’ as an example, you can see the 4th level, i.e., the generic device groups.
The steps to transfer as follows:
Where a transfer agreement is put into place (MDR/IVDR CE marked devices), the following should be outlined:
Where feasible, all three parties should sign the Agreement. Where not feasible, at least the manufacturer and the new EU AR should sign the Agreement.
Timing of the labeling change must be considered.
If there is an EU AR transfer agreement, it should specify the date by which the old EU AR will no longer allow the manufacturer to use their information in any materials, such as labels and promotional materials. The outgoing EU AR may require that date be the same as the termination date. Ideally, the old EU AR would allow for a labeling update transition period.
There is no specific guidance on timing to update the EU AR’s information on product labeling. However, there is a guidance document regarding changing Notified Bodies: NGOB 2006-1
It states that:
“The manufacturer will need to liaise closely with the new NB and the previous NB to agree to the extent that any old labeling (containing the old NB’s number) can be used.”
And further that:
“The transition period should not exceed 6 months. In justified cases this period may be prolonged.”
Therefore, it may be reasonable to apply the same logic to the EU AR. In this case the new and old EU AR should identify a reasonable period in which the old EU AR’s information may continue to be identified. However, that the transition period should not exceed six months without proper justification.
NOTE: even if no formal transfer agreement is executed, the manufacturer should still clearly identify the EU AR termination & labeling transition dates with their old and new providers.
Timing is ultimately dependent upon:
If all parties can move at a reasonable pace, the process can be completed within one month.