The noti­fic­a­tion of the United King­dom (“UK”) regard­ing the with­draw­al from the European Uni­on (“Brexit”) will affect man­u­fac­tur­ers of med­ic­al devices which are in pos­ses­sion of cer­ti­fic­ates issued by a noti­fied body loc­ated in the UK or which have author­ised rep­res­ent­at­ives loc­ated in the UK. These com­pan­ies need to anti­cip­ate the reg­u­lat­ory steps that will be car­ried out as a con­sequence of Brexit so that they can con­tin­ue to oper­ate and sup­ply the EU mar­ket.

Upcom­ing pro­cesses
We can advise and assist man­u­fac­tur­ers of med­ic­al devices with all the steps neces­sary to con­form with cur­rent and future EU legis­la­tion. With our broad inter­na­tion­al net­work and exper­i­ence, we can ensure that the above­men­tioned trans­fers of cer­ti­fic­ates and author­ised rep­res­ent­at­ive are fully com­pleted and imple­men­ted before 30 March 2019 so that the  man­u­fac­turer can con­tin­ue to oper­ate and sup­ply the EU mar­ket after Brexit.

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