Dear Richard,
this indeed seems to be a good advice but that may not reach far enough. There are a couple of aspect an EC REP needs to know and are very specific. Why not involving a professional EC REP who knows exactly what needs to be done?
This particular MDSS service did start many years ago when we were asked to maintain the EC REP function of the manufacturers subsidiary when they failed an authority inspection. This was done under the MDD for a number of clients. It was not very popular since the external EC REP service was well established. Also, it is a little bit more expensive with doing this specifically for a client and in Germany with the Safety Officer.
However, there have been always companies who made their own subsidiary to be their EC REP.
Under the MDR this solution becomes more popular for obvious reasons. We have encountered that manufacturers did this purely to protect their files.
Therefore, please check out our website. We offer now the EC REP service for exactly this solution. Your EC REP maintained by MDSS.
https://mdssar.com------------------------------
Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com------------------------------
Original Message:
Sent: 05-Mar-2020 08:53
From: Richard Vincins
Subject: EU Authorised Representative in Germany
I can not speak to national German law, but there are specific requirements for an Authorised Representative under the EU MDR now. Wherever you are opening the office in Germany, you would probably want to reach out to a local regulatory person and business person to confirm what this "company" as an AR should be registered.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 04-Mar-2020 02:38
From: Anonymous Member
Subject: EU Authorised Representative in Germany
This message was posted by a user wishing to remain anonymous
We are a manufacturer of IVD based in Japan and we have a subsidiary company in the Netherland. The subsidiary company will establish a permanent establishment (PE) in Germany and we would like to appoint them as our Authorised Representative. To make this happen, is there any condition that the German office should fulfill? Should the office be one of GmbH, AG, GbR, KG, OHG, KgaA or UG?
I would highly appreciate your kind help.