New guid­ance for noti­fied bod­ies of MDD/ AIMDD lega­cy device cer­tifi­cates and IVDR class D devices

The Euro­pean Com­mis­sion has issued new guid­ance doc­u­ments that con­cern the activ­i­ties of noti­fied bod­ies under Reg­u­la­tions (EU) 2017/745 and 2017/746 (MDR and IVDR).

• MDCG 2022-3 pro­vides clar­i­fi­ca­tion on ver­i­fi­ca­tion activ­i­ties includ­ing sam­ple or batch test­ing for class D IVD med­ical devices.
• MDCG 2022-4 pro­vides clar­i­fi­ca­tion on sur­veil­lance activ­i­ties for cer­tifi­cates of lega­cy devices under the MDD and AIMDD.

These guid­ance doc­u­ments are intend­ed for noti­fied bod­ies. We would nev­er­the­less strong­ly sug­gest man­u­fac­tur­ers to review the guid­ance to obtain a bet­ter pic­ture of review and sur­veil­lance prac­tices among noti­fied bodies.

Source: MDCG

Author: Oliv­er

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Key guid­ance doc­u­ment on the clas­si­fi­ca­tion of IVDs under the IVDR
• Guid­ance on Qual­i­fi­ca­tion and Clas­si­fi­ca­tion of Soft­ware under the MDR and IVDR Published
• New guid­ance for third-coun­try man­u­fac­tur­ers of COVID-19 IVD tests
• IVDR clin­i­cal evidence
• New guid­ance doc­u­ment shows how to use MDSAP audit reports for MDR/ IVDR sur­veil­lance audits