The UK Med­i­cines and Health­care Prod­ucts Reg­u­la­to­ry Agency (MHRA) pub­lish­es guid­ance about reg­is­tra­tion fees and require­ments for a No-Deal Brexit

These include, among oth­ers, leg­isla­tive infor­ma­tion, infor­ma­tion about CE Mark­ing and label­ing require­ments and also details about registrations:

The reg­is­tra­tion require­ments apply for prod­ucts that will be placed on the mar­ket post Brex­it. Depend­ing on the clas­si­fi­ca­tion of a device, tran­si­tion peri­ods between four and twelve months apply. 

The guid­ance says that a fee of £100 incurs per reg­is­tra­tion appli­ca­tion and also for new and changes to exist­ing reg­is­tra­tions. The require­ments also pro­vide for renewals of the reg­is­tra­tion one year after the ini­tial reg­is­tra­tion appli­ca­tion, and every two years after. The renew­al will be charged with £100 as well.

Please bear also in mind that man­u­fac­tur­ers out­side the UK wish­ing to place their prod­ucts on the UK mar­ket, must appoint a UK Respon­si­ble Per­son. The role refers to the EU Autho­rized Rep­re­sen­ta­tive in the remain­ing EU 27 countries.

Source: MHRA

Vis­it the web­site of Med­i­cine & Health­care prod­ucts Reg­u­la­to­ry Agency, to read the whole article.

If you require fur­ther infor­ma­tion on Brex­it or appoint­ing the UK Respon­si­ble Person

Browse our web­site by key­word “Brex­it”.
Or get direct­ly in touch with our team.