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HIGHLIGHTS
"The NEW CE MARKING"
Get your questions answered for the NEW REGULATION
– THE MDR/IVDR!!!

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In-House Workshops
"The NEW CE MARKING"
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EVENTS
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MDSS Roadshow
- "The NEW CE MARKING” 



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AACC Clinical Lab Expo
July 31-02 August, 2018
Chicago, USA
Booth #4052

RAPS
October 01-04, 2018
Vancouver, BC, Canada
Booth #307




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News and Views January 2018


  • MDSS Workshops – The new CE marking
  • New MDSS service: The new CE marking – get your questions answered
  • The new CE marking – new label 
  • Other news:
          - Notified body applications for the MDR
          - Designation and Notifications of Notified bodies – Timeline
          - New Harmonized standards



MDSS Workshops – The new CE marking

MDSS provides another opportunity to learn more about the new Medical Device Regulation (MDR).  We start the year with two workshops in California: 
Further workshops will follow in other US locations, as well as worldwide.  Please check on us.  

The one-day program outlines the transition and the difficulties, and addresses the highlights of the MDR.  A special focus is given to the new PMS and Vigilance requirements.  
In case you would like to send three or more of your employees to the workshop, a one-day or two-day in-house workshop may be more beneficial. For a one-day seminar, you select the topics most relevant for you, tailoring the seminar to your needs. With a two-day workshop, the MDR will be covered and critical aspects will be addressed in more detail. During the in-house workshops, we will address all questions you may have. Please find further details on our website.

 
New MDSS service: The new CE marking - get your questions answered 

Understanding the challenges of the new MDR becoming your daily business, MDSS is now offering the possibility to have your questions answered and will provide the common understanding of the expectation of the new requirements as available in a phone/Skype conference. Schedule your session here

 
The new CE marking – New label

The label of a medical device must have an indication that the product is indeed a medical device, in order to distinguish it from other devices of similar nature, which may be today’s lifestyle products.  Those bear the CE mark due to other directives or regulations.  Two technically the same products may be utilized in intensive care to monitor vital physiological processes, but may also be used to monitor how you advance with your exercise.  The latter device is not a medical device, and should not be used in the intensive care environment – understandably.  Most certainly other label changes may have to be considered as well. As our client should you get closer to comply with the new regulation and be planning the label update, please contact us in order to also discuss the new Authorized Representative for your new CE marking. 
It should be understood that the new regulation is a complete new CE marking process and a manufacturer will have to apply newly with the NB and also will have to appoint a new AR, which will require a new agreement.  A “simple update” of the appointment will not suffice the requirements bestowed upon the AR.  

 
Other News
  
- Notified body applications for the MDR
TEAM NB, the association for notified bodies informs via its website that most of their members have applied to become a notified body for the new regulation (http://www.team-nb.org/team-nb-has-collected-information-from-members-about-their-re-application/). Lists of those who have applied are being distributed.  However, it will not be clear, for what scope. It is highly recommended to inquire with your notified body whether they have applied and that the scope they applied for includes your products.  

- Designation and Notifications of Notified bodies – Timeline
The Notified Body Operations Group (NBOG) issued a Best Practice Guide for the designation and notification of conformity assessment bodies (http://www.doks.nbog.eu/Doks/NBOG_BPG_2017_1_rev1.pdf), meaning that those - after having been notified - are called notified bodies.  Annex I provides a flowchart of the activities and times.  The most interesting date is the last date given – July 26, 2019 – when upon the final decision on designation by the designating authority the notification process starts.  This means less than a year for the certification of all higher risk class products until the MDR deadline.  Please note that notified bodies will also have to certify manufacturers of reusable surgical equipment as well. This seems to be a tremendous bottleneck, which has been created here. Manufacturers should strategize on prolonging their existing MDD certificate.  If you are looking for explanations why the whole process may be that long, you can find the “Information note on joint assessment under the new regulation on Medical Devices issued by the Commission: 

- New Harmonized standards
The list of harmonized standards has been updated.  EN ISO 13485 has been updated as well. EN ISO 15223-1:2016 is published for the first time and definitively replaces EN 980. Please check in accordance with your QM system review, whether any other standard relevant to your product has been published or updated


Please let us know whether the above information is helpful.


Best regards,
Your MDSS Team