What happens if we do not appoint an Authorized Representative?
Your Notified Body requires appointment of an EC REP before they will issue a CE certificate. Compliance with the applicable Directive is mandatory for any device placed in the EU market; therefore, engaging and identifying your chosen representative is essential. If you do not appoint a rep, your products may be stopped at the border.
Do we have to put the name of the Authorized Representative on our labeling, packaging and IFUs?
Yes. You must list the name and address of the Authorized Rep on the product label, outer packaging and/or Instructions for Use. The name and address of the Authorized Representative should be shown next to the official EC REP logo.
Can a Competent Authority inspect my Authorized Representative?
Yes. A Competent Authority can inspect an Authorized Representative at any time to determine if they understand their role, have direct access to client documentation such as the Technical File/Design Dossier and have processes in place to ensure it can fulfill its role as an Authorized Representative.
Can I change Authorized Representatives after I appoint one?
Yes. You may switch your EC REP without invalidating your product approvals in Europe. However, keep in mind that because your EC REP must be printed on your labeling, switching can be somewhat costly as you will need to change labeling and deal with the issue of products that are already on the market.
What is the role of the Authorized Representative under the MDR?
Authorized Representatives will take on more risk and liability under Europe's new Medical Device Regulation (MDR). The EC REP will be held jointly and severally liable for defective medical devices so you can expect that your representative will monitor your compliance more thoroughly. Download our 15-page white paper to learn more about the MDR changes.