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News and Views November 2018


  • BREXIT
  • INTERNATIONAL MDR HAPPENING



BREXIT
MDSS was hoping to provide you with the good news that the Brexit (the UK leaving the European Union) on 2019 March 29 at 11:00 PM (23:00) would be somewhat reconsidered with a good Brexit “deal”. The negotiations on a specific Brexit deal should have been concluded in October. That deadline was extended to November and now December as we take it from the News distributed in Germany. 

For medical device manufacturers there are different options to consider and for companies it may be important to know the following for planning purpose:

1. In case of no deal, the UK becomes a third country to the EU. Boundaries are going to be put in place and all the rules of the EU are not applicable any longer. The UK has to decide on how to establish national rules. This may be as easy that they simply declare the current rules as applicable for their country. However, this is the main reason for the UK to leave since they want to have their own laws. Therefore, completely new rules may apply sooner than later.

2. The conclusion of a deal will get us all an additional transition period and for that time period some of the EU rules are still applicable. It simply provides time to implement the deal. This deadline is then the 31 December, 2020.

All industries are affected and for the medical industry it is important to know in case of a hard Brexit that Notified bodies (NB) and authorized representatives (AR) will lose their status with the Brexit. Manufacturer, also Manufacturer in the UK will need a NB and an AR from the EU. There is the discussion that it cannot be that from one day to the next formerly approved products cannot be sold any longer. These are nice thoughts but keep in mind these are purely political and not safety issues. An additional time to market products may not be granted since this Brexit date is no surprise (anymore).

Talk to your notified body and most certainly if you are not a client of MDSS reading these News and Views talk to your current AR. A new AR or NB may need to be considered.



The UK for the time being will accept CE marked products. Therefore, an AR or NB from the UK is not indicated yet. However, that may change and MDSS has put provisions in place which will be activated if that happens.


Manufacturers must plan early on in order to update the product labeling. Keep your inventory and stock supplies in mind when planning those updates. Should your inventory last for more than three months then implementation should start now.

Our MDR Happening in December will address the latest Brexit news.
 

INTERNATIONAL MDR HAPPENING
"The NEW CE MARKING" - December 11-12, 2018. Don't miss the chance to get your questions answered! For more information click here.


Your MDSS Team