Is it possible to change your EU Authorized Representative?

Absolutely. Manufacturers have the option to switch their European Authorized Representative (EU AR) to a different one. While the process of changing providers is not explicitly outlined in the old Directives, the new MDR/IVDR clearly specifies the requirements for transitioning to a new provider.

Can I have multiple EU Authorized Representatives?

Only one EU Authorized Representative (also known as EC-REP) can be appointed per device group. This rule applies to both the old Directives and the new MDR/IVDR. This means that you can appoint more than one EU AR simultaneously, but each EU AR must represent different products.

What is a generic device group?

A generic device group, as defined by the MDR/IVDR, refers to a set of devices that have similar intended purposes or share common technology, allowing them to be classified in a generic manner that does not reflect specific characteristics.

Further clarification can be found in the EU guidance document MDCG 2019-13:

• For the MDR, a generic device group corresponds to the 4th level of the European Nomenclature on Medical Devices (EMDN).

• For the IVDR, a generic device group corresponds to the 3rd level of the EMDN, combined with the most appropriate IVD code.

Steps to Transfer

1. Establish the date when the new EU AR agreement will come into effect and execute a transition agreement (for MDR/IVDR CE marked devices).

2. Update MDR/IVDR CE Marking certificates and notify the Notified Body (if applicable).

3. Update relevant documentation.

4. Update EUDAMED registration.

Key Elements in the Transfer Agreement:

• Clearly specify the termination date of the outgoing EU AR and the start date of the incoming EU AR.

• Define the duration until which the outgoing EU AR's information may be indicated in manufacturer-supplied materials, such as labels and promotional materials.

• Address the transfer of documents, including confidentiality and property rights.

• Outline the obligation of the outgoing EU AR to forward complaints or incident reports to the manufacturer and/or new EU AR, even after the termination date.

• Ideally, all three parties should sign the agreement. At the very least, the manufacturer and the new EU AR should sign it.

Labeling Updates

• The EU AR transfer agreement should specify the date by which the old EU AR will no longer allow the manufacturer to use their information in labeling and promotional materials.

• Ideally, a labeling update transition period should be established to facilitate a smooth transition.

Timing

With efficient coordination among all parties, the transfer process can typically be completed within one month.