Great Britain is on the verge of estab­lish­ing its post-EU med­ical devices reg­u­la­to­ry sys­tem, but uncer­tain­ty remains about the future role of local con­for­mi­ty assess­ment bod­ies (CABs).

Ear­li­er this year, the Med­i­cines and Health­care Reg­u­la­to­ry Prod­ucts Agency (MHRA) has des­ig­nat­ed two more approved bod­ies, bring­ing the capac­i­ty of con­for­mi­ty assess­ment bod­ies for issu­ing UKCA marks in Great Britain to a total of nine. How­ev­er, as per Feb­ru­ary 2024, there were only four approved bod­ies with an IVD designation. 

There is gen­er­al uncer­tain­ty about the pre­cise future role of CABs as the UK’s devel­op­ing device reg­u­la­to­ry sys­tem is defined by the upcom­ing four statu­to­ry instru­ments (SI), which are planned to be due in the fur­ther course of this and next year.

We will include fur­ther updates as they come up. Should you have any ques­tions or com­ments, please don’t hes­i­tate to get in touch.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website