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News & Views, January 2019

2019.01.08

  • Brexit
  • MDR/IVDR EU Commission website





Brexit


The Brexit issue is not resolved yet.  The vote in the UK Parliament is to be set by mid-January.  As stated before, Europe is excellent with last minute solutions!  This is not good for business, and preparations for the worst case scenarios should be implemented, for example a change of Notified Body (NB) or the Authorized Representative (AR), or both.  A change of labeling etc. has to go along with that. This has been discussed at length in our previous News and Views.  Contact us if you have any specific questions concerning your products.



MDR/IVDR EU Commission website


We are halfway through the transition period, and it is recognized that this time is actually intended for the Commission and regulators to define the regulation further.  For the manufacturers it means they have to deal with it and must make use of the additional timeline with their MDD certificate (we call it soft transition).  Please keep in mind that a lot of MDR requirements must be implemented even with an MDD cert. in place. It is highly recommended -  if not done already - to closely monitor the European Commission website.  A lot of relevant information is published there, and you may additionally subscribe to the news.  

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