What about Brexit?

On June 23, 2016, the Unit­ed King­dom (UK) vot­ed for the UK to leave the EU, which is com­mon­ly referred to as Brex­it. Since then, there has been no clear direc­tion with regards to the out­come and the sit­u­a­tion appears to be high­ly volatile.

In the case of a No-Deal sce­nario mean­ing that there will be a non-reg­u­lat­ed leave of the UK, the UK will become a third coun­try – this has sev­er­al impli­ca­tions that should be considered:

• CE cer­tifi­cates issued by UK Noti­fied Bod­ies will lose valid­i­ty imme­di­ate­ly with Brex­it date
• Autho­rized Rep­re­sen­ta­tives based in the UK will no longer be able to act as an Autho­rized Rep­re­sen­ta­tive under the EU leg­is­la­tion – only Autho­rized Rep­re­sen­ta­tives locat­ed in one of the remain­ing EU coun­tries will be recognized
• Dis­trib­u­tors locat­ed in one of the remain­ing EU coun­tries who dis­trib­ute prod­ucts from the UK will become importers with all legal consequences
• CE marked devices will con­tin­ue to be rec­og­nized for a lim­it­ed peri­od of time in the UK
• Man­u­fac­tur­ers must reg­is­ter their med­ical devices and in vit­ro diag­nos­tic med­ical devices with the MHRA after Brex­it day – if the man­u­fac­tur­er is not locat­ed in the UK, a UK Respon­si­ble Per­son must be assigned

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