Dear Sam,
Thank you for the good work. MDSS would not participate in surveys, however indeed the information is interesting.
Asking for MDR experienced AR is somewhat early since the regulation is new with limited experience. A manufacturer should connect itself to a firm who has done authorize representation for years with the MDD / IVD and knows the differences with the MDR/IVDR.
This is a good time to provide you with additional MDSS information to complete your survey.
- MDSS offers the MDR/IVDR agreement. In fact over 30% of our clients have received the agreement. The agreement was reviewed by two respective lawyers who specialize in medical devices (DE and NL). The draft was shared with clients to get their input and a great collaboration was provided, which make the contract more workable.
- MDSS offers additional services for the "NEW CE Marking" for all types of Economic Operators (EO). Those services are reserved currently to our clients who have requested them. Once they are proceduralized they will be offered to everyone. Please watch our website (mdssar.com).
- MDSS was the very first AR in 1994! The idea was brought up by a US firm who did not want to have his distributor taking over this role– for obvious reasons. The German consultant Dr. Haindl created then officially MDSS GmbH to take over the business. We are looking back at 25 years of AR services.
- MDSS was the first AR certified to ISO and then to EN ISO 13485 with TUV.
- Upon the receipt of pertinent information outlined in brief questionnaire MDSS provides a quote immediately. It is important not only to compare the annual fee. There are additional services to consider:
- Additional European national notifications (IT, ES etc.). Please note not all ARs offer these additional registrations
- Free Sales Certificates - can only be obtained via the AR.
- Handling of vigilance cases with all authorities.
- etc.
Certainly, service is important and we are very sensitive in terms of the client's expectations, which is evident on how we conduct our business. For example, MDSS was the first AR offering national registrations services due to the feedback from clients. And now we are adjusting with offering the additional services for the new CE Marking based on the client's requests.
I hope you will be able to add the information to the table.
Please add my contact information (l.moeller@mdssar.com) and the new MDSS domain (mdssar.com)
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Ludger Moeller
President
MDSS GmbH
l.moeller@mdssar.com------------------------------
Original Message:
Sent: 22-Nov-2019 15:29
From: Sam Lazzara
Subject: EU Authorized Rep - MDR
In August 2018, I did a survey of some European Authorized Representatives via email.
The results are posted here.
My source for determining survey participants was the EAAR member list.
Disclaimer: The collected information may not be accurate. Contact the EC-REPs directly for their current information.
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Sam Lazzara
Medical Device Quality Consultant
San Francisco Bay Area, California USA
https://mdqc.blog
Original Message:
Sent: 15-Nov-2019 10:05
From: Anonymous Member
Subject: EU Authorized Rep - MDR
This message was posted by a user wishing to remain anonymous
Hi,
Can anyone suggest a good EU Authorized Rep providing services under MDR?
Thanks in advance!