Is it possible to transfer your EU AR?

 Can I appoint more than one EU AR?

 Steps to Transfer

 What is needed in the Transfer Agreement?

 Labeling Updates

 Timing

Is it possible to transfer your EU Authorized Representative?

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

Can I appoint more than one EU Authorized Representative?

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:

• 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

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 4^th level, i.e., the generic device groups.

Steps to Transfer

The steps to transfer as follows:

1. Determine the date that the old EU AR will stop representing you in the market and the date the new EU AR agreement will be effective
2. If you have Notified Body CE marked devices, notify your Notified Body of the change
   • The EU Authorized Representative is named on MDR/IVDR CE Marking certificates
3. If you have MDR/IVDR CE marked devices, then 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
4. Old EU AR:
   • If they have registered Class I or IVD devices with the competent authority where they are located, they should notify the competent authority that they no longer act as the EU AR for those devices
   • If they receive complaints or reports of incidents, they should forward this to the manufacturer and/or new authorized representative
5. New EU AR:
   • If you have any Class I or IVD devices, the new EU AR will notify their national competent authority that they represent those devices
6. Update relevant documentation, e.g., labels, instructions for use, technical documentation file, Declaration of Conformity, vigilance/post-market surveillance procedures
7. If you have registered your company in EUDAMED, then you should log-in and update the EU AR information in your account

What is needed in the Transfer Agreement?

Where a transfer agreement is put into place (MDR/IVDR CE marked devices), the following should be outlined:

• • The date of termination of the outgoing EU AR and the beginning date of the incoming EU AR
  • The date until which the outgoing EU AR 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 EU AR to forward any complaints or incident reports to the manufacturer and/or new EU AR, 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 EU AR should sign the Agreement.

Labeling Updates

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

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.