The intend­ed use state­ment of med­ical devices is a cen­tral aspect in the Euro­pean reg­u­la­to­ry envi­ron­ment. The intend­ed use dri­ves the require­ments a device must ful­fill. This has already been the case under the med­ical devices directives.

Under Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices or in vit­ro diag­nos­tic med­ical devices respec­tive­ly (MDR and IVDR) with their more spe­cif­ic pro­vi­sions, this becomes even more important.

Astra­Con has devel­oped an online tool to help man­u­fac­tur­ers gen­er­at­ing an appro­pri­ate intend­ed use state­ment. The tool regards rel­e­vant design and per­for­mance char­ac­ter­is­tics and is in line with cur­rent reg­u­la­to­ry require­ments. It can be accessed here.

Should you have any ques­tions or com­ments, please don’t hes­i­tate to get in touch.

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website