2 weeks ago
Medical Device and Pharmaceuticals Lawyer, Head of Life Sciences Sector Group, Fieldfisher LLP
The UK is heading ever closer to the precipice of a “no deal” Brexit. It is now less than two months until the UK is due to exit the EU on 29th March and no agreement acceptable to the UK parliament has been reached on how that exit will be managed.
For medical device companies a “no deal” Brexit means that there will be no transition period. Any manufacturer whose EC certificates of conformity are issued by a notified body in the UK must have them transferred to a notified body in the EU27 before 30 March 2019. If they fail to do this, their devices will not be able to be sold on the market in the EU27 until new certificates are issued by a new notified body.
Manufacturers must act immediately to avoid this catastrophe for their EU sales. Depending on which UK notified body is used, for some manufacturers it will already be too late: they are out of time to make the transfer. There are some potential stop-gaps which can be tried, albeit that they are not tested in this singular situation and therefore not guaranteed to be successful.
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