Since 2021, the UK has been offi­cial­ly sep­a­rat­ed from the EU reg­u­la­to­ry sys­tem. How­ev­er, CE-marked med­ical devices and IVDs are still accept­ed in the UK and this accep­tance will remain valid until 2030. 

Man­u­fac­tur­ers out­side the UK must appoint a UK Respon­si­ble Per­son (UKRP) to place or con­tin­ue plac­ing their devices on the UK mar­ket. Sim­i­lar­ly, British man­u­fac­tur­ers now need an EU-based Autho­rized Rep­re­sen­ta­tive to sell their prod­ucts with­in the EU or EEA.

mdi Europa is here to sup­port your reg­u­la­to­ry needs in this evolv­ing land­scape. As a proud mem­ber of the reg­u­lan­et® net­work – a glob­al alliance of qual­i­fied inde­pen­dent con­sul­tan­cies spe­cial­iz­ing in devel­op­ment, reg­u­la­to­ry affairs, mar­ket access, and life­cy­cle man­age­ment – mdi Europa offers com­pre­hen­sive exper­tise. Our reg­u­lan­et® affil­i­a­tion enables us to con­nect you with trust­ed part­ners who can serve as your UKRP, pro­vid­ing you with tar­get­ed reg­u­la­to­ry support.

For more infor­ma­tion or assis­tance, please feel free to con­tact us.