Your EU Authorised Representative & PRRC for MDR/IVDR medical devices

Changing your EU Authorised Representative (Article 12)

Manufacturers can change their EU Authorised Representative, but Article 12 of the MDR and IVDR requires the switch to be defined in an agreement so that there is never a gap in representation or in vigilance reporting.

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Article 12 MDR / IVDR Agreement with outgoing and incoming AR Defined labelling transition No gap in vigilance

What the agreement must address

The detailed arrangements are set out in an agreement between the manufacturer, where practicable the outgoing Authorised Representative, and the incoming Authorised Representative. It must address at least:

The date of termination of the mandate with the outgoing Authorised Representative and the start date of the mandate with the incoming one
The date until which the outgoing Authorised Representative may still be indicated in the information supplied by the manufacturer, including promotional material
The transfer of documents, including confidentiality aspects and property rights
The obligation of the outgoing Authorised Representative, after the end of the mandate, to forward to the manufacturer or the incoming Authorised Representative any complaints or reports from healthcare professionals, patients or users about suspected incidents

Practical steps

Review

The incoming AR reviews your documentation before accepting the mandate in writing.

Agreement

Sign the Article 12 agreement with fixed dates for the handover.

Registrations

Update EUDAMED actor data and inform your Notified Body where one is involved.

Labelling

Switch labels and instructions to the new AR by the agreed date; plan for stock already on the market.

When the outgoing AR will not cooperate

Article 12 requires the outgoing Authorised Representative to be party to the agreement only "where practicable". If the relationship has broken down, the manufacturer and incoming AR still document the arrangements, and the manufacturer should keep evidence of the notice of termination and of its attempts to obtain the documents.

Frequently asked questions

Can I change my EU Authorised Representative at any time?

Yes, subject to the terms of your mandate. Article 12 MDR/IVDR requires the change to be defined in an agreement covering the handover dates, labelling transition, document transfer and forwarding of incident reports.

Do I need to relabel devices already on the market?

The agreement sets the date until which the outgoing Authorised Representative may still be indicated in the information you supply. Devices already placed on the market before the change are not relabelled by default.

Does the Notified Body need to know?

Where a Notified Body is involved, inform it of the change of Authorised Representative as required by your certification agreement.

Check whether you need an EU Authorised Representative

Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.

Free eligibility check