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News and Views - November, 2018 - Update


  • International MDR Happening
  • Latest Brexit News


The news in Europe develop quickly. The Brexit is  a hot topic and affects the medical devices industry. The MDR implementation is moving along and is crucial for the CE marking.  Please consider the International MDR Happening and the latest News on Brexit.

 

Ludger Möller
President
Medical Device Safety Service

 


International MDR Happening

Join the MDSS MDR workshop - the MDR Happening on December 11 and 12. The workshop will take place in Hannover Germany, but certainly in English, and is geared to our clients. MDSS experts will share their knowledge on how to implement the MDR requirements. 

Our workshop has a different flavor, focus and provides different perspectives. We outline how to implement the MDR but also on how to deal with the notified body. 

A program around the event provides the opportunity to exchange views in a more relaxed environment. Critical questions may be better answered with a good German beer. Most certainly, you may extend your stay to enjoy the winter activities in Germany especially the famous Christmas markets in and around Hannover.

 

 
Latest Brexit News

Two scenarios are on the table.

1.    Hard Brexit
2.    Soft Brexit with some sort of deal with a transition until 31. December 2020.


On November 20, 2018 the remaining member states of the EU (remaining EU) voted for the DEAL negotiated. The news outlet portray that it will be business as usual with the exception that the UK will not be able to influence anything in regards to EU laws any longer.

One interesting aspect is striking. The majority of the British people do not like the deal. Both the Brexit supporters and the ones against the Brexit. Therefore, it seems to be the “perfect” compromise! 

Now, it is up to the UK to decide. Hopefully, the UK Parliament will come to a wise decision on December 7, 2018.

Clients already had experiences with the Brexit in regards to their notified body (NB). UK notified bodies prepared for it by moving clients to a sister company with NB status in the remaining EU. 

BSI as one of the bigger NB in EU was successful to start their NB in the Netherlands (NL) just last week. It is mentioned, because many questions are received from BSI clients regarding the transition. On their website it is outlined, that clients may change now to BSI NL. It is described as an easy process and BSI will provide a long transition since everything is under control with BSI UK and BSI NL, being the same company.

There is one aspect missing in the document. In case of a hard Brexit, the question arises whether the remaining EU will accept BSI UK NB indication on the label. Someone would hope for but that remains to be seen.

In case you play it safe with changing or plan to change to a NB in the remaining EU, then do not wait with the label change indicating the new NB number.

 


Best regards,
Your MDSS Team