Even now after the draft text of the withdrawal agreement has been agreed by Government, there remains considerable uncertainty regarding the commercial impact of Brexit and how this will affect UK based medical device manufacturers who CE mark devices.
As we have done over the last 2 years, we at Advena track UK political news closely and it seems as if UK device manufacturers will eventually need to appoint an EU Authorised Representative (EC REP) and label their devices with their address. This EC Rep must have a physical place of business in the EU27.
The key date to consider is the 29th March 2019, after this date UK based device manufactures may no-longer be permitted to legally place product on the market without appointing an EC Rep. (click here).
If a deal is struck between the EU and the UK the implementation period that has already been agreed allows UK manufacturers until December 2020 to appoint an EC Rep and update your information and materials, including, but not limited to, packaging, product labels, IFU’s, brochures, CE Certificate, and Declarations of Conformity where you can be expected to indicate the name and address of your EC Rep.
However, if the UK crashes out of the EU without a deal, and this is still a definite possibility the implementation period is removed and the EU have not made a commitment to provide a transition period, meaning that UK device manufacturers could potentially be locked out of the EU until such time that they have appointed an EC Rep, updated device registrations and their information and materials as mentioned above. Therefore the 29th March 2019 could be a critical date!
We strongly recommend UK based medical device manufacturers contact Advena to discuss the options available to them. We are uniquely based in the UK and in Malta, we offer our EU Authorised Representative service from Malta, but also have offices in the UK, therefore offering a local service while guaranteeing EU market access. And of course we are English speaking as is our team in Malta.
With over 20 years’ experience as a provider of regulatory services we have a wealth of knowledge that you can benefit from.