Article 12 Change of authorised representative

Many potential customers frequently inquire about whether it's possible to change their authorized representative.

Yes, this is allowed under MDR 2017/745 Article 12.

Article 12 states: "An agreement between the manufacturer and both the outgoing and incoming authorised representatives must delineate the process for transitioning representatives. The agreement should specify: (a) the commencement and conclusion dates of each representative's mandate; (b) the duration for which the outgoing representative may appear in manufacturer materials; (c) protocols for document transfer, addressing confidentiality and ownership; and (d) the responsibility of the outgoing representative to forward any pertinent complaints or incident reports following the end of their mandate."

What are the challenges?

Medical device packaging includes information on the current authorized representative.

What happens in case of changing the authorized representative?

The manufacturer has identified the final batch containing the current authorized representative details and will notify the relevant parties accordingly.

Do you want to change your current Authorized Representative?

Contact us to discuss the possibilities

eucerep@eucerrep.com

WhatsApp +31685008887