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May 21, 2019 - St. Paul, MN, USA

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August 9, 2019 - Anaheim, CA, USA


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August 4-8, 2019
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News and Views October 2017


  • MDSS Workshops - new Medical Device Regulation
  • Codes for the designation of Notified Bodies in the field of medical devices and in vitro diagnostic medical devices“


MDSS Workshops - new Medical Device Regulation

After a very successful first one-day workshop in Anaheim, California, MDSS organized a second one-day workshop in San Diego, concerning the new IVDR. We are thankful for the TÜV Rheinland’s support in both workshops, adding value through the exchange of information and interpretation from the perspective of a notified body (NB). Special thanks to Mr. Ronald Sills and Mr. Balázs Bozsik, presenters from TÜV.

A third workshop was hosted by MDSS in September in the Seattle area with a very positive feedback from the attendees.

MDSS´ President, Mr. Moeller, was also invited to speak at a RAPS Twin Cities Chapter event on the 6th of September. Key topics presented were the stringent timeline and the tighter requirements for the manufacturers regarding the Post-Market Surveillance (PMS) and Vigilance.
 
The extremely positive feedback as well as the acknowledged benefits for the companies motivates MDSS to keep on providing additional workshops throughout the year at different locations. 

MDSS, Ludger Möller, has been invited for one or two day workshop geared specifically towards the company requirements.   The benefit for the company may be multiplied due to the specific aspects which may be addressed as well as the increased number of employees that can attend. 
To read what the participants said about our workshops click here.

Please contact us if your company would like MDSS to provide an In-house workshop.



Codes for the designation of Notified Bodies in the field of medical devices and in vitro diagnostic medical devices“

-        It is the first implementing act.  Reference in the MDR is Article 42 point 13.

"13. The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of codes and corresponding types of devices for the purpose of specifying the scope of the designation of notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). The Commission, after consulting the MDCG, may update this list based, inter alia, on information arising from the coordination activities described in Article 48."

The draft is now open for public feedback until 25/10/2017 at:

-        It may be beneficial to comment by a manufacturer if your product may not be covered.
-        It may be beneficial to check early under what code your product falls and that your notified body receives the designation for it.


Your MDSS Team