New Euro­pean Com­mis­sion guid­ance doc­u­ment on MDR med­ical device classification

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:

• Sec­tion 3.1.5 on active med­ical devices expands the pre­vi­ous MEDDEV word­ing and also specif­i­cal­ly includes devices like elas­tomer­ic pumps as examples.
• Reusable sur­gi­cal instru­ments are clear­ly assigned to rule 6. Exam­ples are scalpels, ream­ers, drill bits, saws, for­ceps, etc. It thus seems as if the guid­ance strength­ens the posi­tion that reusable instru­ments or devices that are not clear­ly sur­gi­cal do not fall into this cat­e­go­ry. The lat­ter would be exempt from noti­fied body cer­ti­fi­ca­tion. At the same time, these prod­ucts may not make use of the extend­ed tran­si­tion peri­od until May 2024.
• Ultra­sound gels will con­tin­ue to fall under rule 1 and thus will not require a noti­fied body under the MDR.
• Sec­tion 4 on rule 8 con­tains poten­tial­ly con­tro­ver­sial expla­na­tions regard­ing spinal implants where devices that were pre­vi­ous­ly assumed to be class IIb devices could be inter­pret­ed to fall into risk class III.

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

• bsi arti­cle on clin­i­cal eval­u­a­tion require­ments under the MDR
• Stan­dard ISO 20417:2021 for the MDR and IVDR published
• EU clear­ance for MDR and IVDR har­monised standards
• mdi Europa expe­ri­ence on MDR tech­ni­cal doc­u­men­ta­tion reviews
• Sup­port­ive Infor­ma­tion Sec­tion MDR
• Browse by cat­e­go­ry “MDR”