The Euro­pean Com­mis­sion has put anoth­er item on its already long list of guid­ance doc­u­ments for med­ical device manufacturers.

MDCG 2021-24, Guid­ance on clas­si­fi­ca­tion of med­ical devices, will prob­a­bly be among the set doc­u­ments for all those who are involved in reg­u­la­to­ry affairs around med­ical products.

The 57-page paper is struc­tured sim­i­lar­ly to its pre­de­ces­sor under the med­ical devices direc­tive (MDD). Sec­tions 1 to 3 pro­vides gen­er­al infor­ma­tion about the con­text of the guid­ance and also ref­er­ences impor­tant def­i­n­i­tions and prin­ci­ples of the clas­si­fi­ca­tion system.

We high­ly rec­om­mend to care­ful­ly review MDCG 2021-24 and ensure that no dis­crep­an­cies in your MDR clas­si­fi­ca­tion ratio­nale comes up. 

Sec­tion 4 then includes flow­charts for the appli­ca­tion of clas­si­fi­ca­tion rules, but it also pro­vides gen­er­al expla­na­tions and exam­ples for each rule. 

Here are some exam­ples of inter­est­ing changes/ aspects where the doc­u­ment rais­es top­ics of con­cern. Please note that these are prod­uct spe­cif­ic – depend­ing on the prod­uct range, fur­ther issues may be relevant:

Should you wish us to pro­vide you with the guid­ance doc­u­ment or should you have any ques­tions, please don’t hes­i­tate to get in touch. Please feel also free to vis­it our library sec­tion for this and oth­er poten­tial­ly rel­e­vant documents.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website