Is it possible to transfer your CH-REP (Swiss AR)?

 Can I appoint more than one CH-REP (Swiss AR)?

 Steps to Transfer

 What is needed in the Transfer Agreement?

 Labeling Updates

 Timing

Is it possible to transfer your CH-REP?

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.

For more information on the role of the CH-REP and how Casus can help, please read: Swiss Authorized Representative Overview

Can I appoint more than one 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.”

What is a 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:

• • the 4th level of the European Nomenclature on Medical Devices (EMDN) under the MDR
  • the 3^rd level of the EMDN + the most appropriate IVP code under the IVDR

Below is an image from the EMDN database. Using ‘needles’ as an example, you can see the 4^th level, i.e., the generic device groups.

Swissmedic’s FAQ “Medical Device Nomenclature” references the EU Commission and MDCG’s decision to utilize EMDN codes.

Steps to Transfer

The steps to transfer as follows:

1. 1. Determine the date that the old CH-REP will stop representing you in the market and the date the new CH-REP agreement will be effective
   2. Article 51 paragraph 4 of the MedDO and Article 44 paragraph 5 of IvDO reference MDR/IVDR Article 12 for governing changes of Authorised Representatives.
      • Article 12 ‘Change of authorized representative’ stipulates that an agreement outlining the transition should be executed between the manufacturer, new EU AR and, where practicable, the old EU AR.
   3. Update your documentation, e.g., labels, instructions for use, technical documentation file, Declaration of Conformity, vigilance/post-market surveillance procedures.
   4. Execute Swissmedic mandate with the new AR.
   5. Ongoing: The old CH-REP should forward any complaints or reports of incidents to the manufacturer and/or new CH-REP.

What is needed in the Transfer Agreement? 

Where a transfer agreement is put into place, the following should be outlined:

• The date of termination of the outgoing CH-REP and the beginning date of the incoming CH-REP
• The date until which the outgoing CH-REP may be indicated in the information supplied by the manufacturer (e.g., labeling), including any promotional materials
• The transfer of documents, including confidentiality aspects and property rights
• The obligation of the outgoing CH-REP to forward any complaints or incident reports to the manufacturer and/or new CH-REP, even after the termination date of their agreement

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.

Labeling Updates

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

Timing is ultimately dependent upon:

• • The timeframe for the manufacturer to update its documentation to reflect the new EU AR, including the Notified Body issued CE Marking certificate, where the EU AR’s information is identified
  • The timeframe for the old EU AR to de-notify any Class I and IVD devices they may have registered with their national competent authority
  • The timeframe for the new EU AR to notify Class I and IVD devices to the national competent authority where they are located

If all parties can move at a reasonable pace, the process can be completed within one month.