The Euro­pean Com­mis­sion has launched a tar­get­ed revi­sion to address the imple­men­ta­tion gaps of the med­ical devices and IVD med­ical devices reg­u­la­tions, clar­i­fy def­i­n­i­tions, reduce admin­is­tra­tive bur­den and strength­en patient safe­ty and sup­ply resilience. Its pur­pose is to gath­er stake­hold­er evi­dence via a pub­lic con­sul­ta­tion to pre­pare focused, pro­por­tion­al amend­ments that improve reg­u­la­to­ry pre­dictabil­i­ty for man­u­fac­tur­ers, noti­fied bod­ies and author­i­ties while pre­serv­ing high safe­ty standards. 

The link can be found here – con­sul­ta­tion is open until Octo­ber 6.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website