Yes. It is possible for manufacturers to switch from one Swiss Authorized Representative (CH-REP) to another.
The Swiss medical device (MedDO Article 51(4)) and IVD (IvDO Article 44(5)) Ordinances reference Article 12 of the EU MDR and IVDR as the governing requirements for changes in the CH-REP.
Only one Swiss Authorized Representative (aka CH-REP) may be appointed per device group. This mirrors the requirements in Europe, as the Swiss Regulations incorporate the MDR/IVDR.
This means, you may appoint more than one CH-REP at the same time; however, only if each CH-REP represents different generic device groups. This is per an FAQ on Swissmedic’s website “Authorised Representative (CH-REP)” which references Article 11(2) of the MDR/IVDR and further states:
“The designation shall be effective at least for all devices of the same generic device group.”
Article 4(2) of the Swiss MedDO and IvDO reference the MDR/IVDR’s definition of a generic device group:
“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 states the following can be considered the generic device group:
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.
For more information on how to identify a generic device group, please read: EU Guide: GMDN, EMDN and CND Codes
The steps to transfer as follows:
Overview of role & How Casus can help
Where a transfer agreement is put into place, the following should be outlined:
Where feasible, all three parties should sign the Agreement. Where not feasible, at least the manufacturer and the new CH-REP should sign the Agreement.
Timing of the labeling change must be considered.
If there is a CH-REP transfer agreement, it should specify the date by which the old CH-REP will no longer allow the manufacturer to use their information in any materials, such as labels and promotional materials. The outgoing CH-REP may require that date be the same as the termination date. Ideally, the old CH-REP would allow for a labeling update transition period.
There is no specific guidance on timing to update the CH-REP’s information on product labeling. However, as the MedDO and IvDO reference the MDR and IVDR respectively, then guidance in the EU can be considered.
Related to changing notified bodies, NGOB 2006-1 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.”
So, it may be reasonable to apply the same logic to changes in authorized representatives. In this case the new and old CH-REP should identify a reasonable period in which the old CH-REP 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 CH-REP 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.