Although there is less than 3 months to go until the Brex­it date, con­di­tions have not yet been agreed upon and it is like­ly that a no-deal will be reached. 

MHRA notice on No-Deal Brexit

The cur­rent no-deal Brex­it notice from the UK gov­ern­ment states that busi­ness­es retail­ing devices in the UK require a ‘UK Respon­si­ble Per­son’ to be actu­al­ly sit­u­at­ed in the UK and not just have an address there if the busi­ness is not based there.

If there is a no-deal out­come man­u­fac­tur­ers out­side the UK will have to have a ‘UK Respon­si­ble Per­son‘ locat­ed in the UK.

The government’s notice explains that if there is a no-deal out­come man­u­fac­tur­ers out­side the UK will have to have a ‘UK Respon­si­ble Per­son ‘ locat­ed in the UK. The func­tion of this per­son would be akin to those of the Euro­pean Autho­rized Rep­re­sen­ta­tive under the EU med­ical device legislation.

The UK Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA), which pub­lished the guid­ance note, says that where a device man­u­fac­tur­er is not based in the UK, the reg­is­tra­tion of a prod­uct with the MHRA must be tak­en on by a ‘UK Respon­si­ble Per­son’ rec­og­nized in the UK and hav­ing a UK reg­is­tered address who will be account­able for the prod­uct in the UK. This per­son has to be in atten­dance at the address and has to pro­vide par­tic­u­lar infor­ma­tion for the MHRA if request­ed, for exam­ple, dec­la­ra­tions of con­for­mi­ty and tech­ni­cal documentation. 

The Euro­pean Com­mis­sion on the oth­er hand stip­u­lat­ed in an ear­li­er notice to stake­hold­ers that if there was a no-deal Brex­it sit­u­a­tion, com­pa­nies with an autho­rized rep­re­sen­ta­tive based in the UK would have to find a new Autho­rized Rep­re­sen­ta­tive in an EU coun­try if they want a rep­re­sen­ta­tive to per­form tasks on their behalf in the EU. 

Vis­it the web­site of the UK gov­ern­ment, to read the orig­i­nal text.
Or browse our web­site by key­word “Brex­it”.

mdi Europa is aware that the sit­u­a­tion is con­fus­ing. Should you require fur­ther details, please don’t hes­i­tate to get in touch.

Sources: Medtech Insight (an Infor­ma prod­uct), MHRA