All About Brex­it – But We’re Not Clairvoyant

Brex­it or no Brex­it? Deal or no deal? As long as the British Gov­ern­ment is not in har­mo­ny with itself the sto­ry of “in or out” will keep the world occu­pied with a big rid­dle. mdi Europa makes an effort to pro­vide you with all the infor­ma­tion that is avail­able, but we can not pre­dict the future … yet.

What we have found out about Brex­it and reg­u­la­to­ry changes for med­ical devices and in vit­ro diag­nos­tics man­u­fac­tur­ers so far

mdi Europa keeps an eye on all upcom­ing changes – whether it is in the case of a deal or aNo-deal Brex­it. Usu­al­ly, author­i­ties in Europe and the Unit­ed King­dom keep their lev­el of infor­ma­tion low. Spec­u­la­tions do not nec­es­sar­i­ly become real­i­ty, so all involved par­ties have to be patient.

Below you will find an overview of our arti­cles relat­ed to Brexit 

• MHRA draft recog­ni­tion pol­i­cy for inter­na­tion­al approvals
• UK-approved body capac­i­ty increas­es but not for IVDs
• Great Britain’s plan to accept med­ical devices reg­is­tered abroad
• UK MHRA gives CE marked devices new tran­si­tion deadlines
• UK updat­ed guid­ance will reflect EU extensions
• UK MHRA’s new and high­er charges for med­ical devices
• Extra year for CE-marked devices to access UK market
• Con­sul­ta­tion on amend­ing UK med­ical devices regulations
• Addi­tion­al MHRA guid­ance for med­ical device companies
• Lat­est UK MHRA updates on North­ern Ire­land and EU device reg­u­la­tion guidance

Oth­er sources con­cern­ing the Brex­it – on our web­site and beyond

Browse our web­site by key­word Brex­it.
Vis­it web­site ec.europa.eu, sec­tion Brex­it Info.
Vis­it web­site gov.uk, sec­tion Brex­it in a No-Deal event.

In case you have fur­ther ques­tions on Brexit

You are wel­come to get in touch with our team.