The Med­ical Device Coor­di­na­tion Group (MDCG) has revised its “Guid­ance on appro­pri­ate sur­veil­lance regard­ing the tran­si­tion­al pro­vi­sions under Arti­cle 120 of the MDR with regard to devices cov­ered by cer­tifi­cates accord­ing to the MDD or the AIMDD”. 

The doc­u­ment intend­ed for noti­fied bod­ies, but is nev­er­the­less is valu­able to read for oth­er inter­est­ed par­ties as it pro­vides addi­tion­al clar­i­fi­ca­tion on impor­tant aspects for the extend­ed tran­si­tion peri­od of lega­cy devices.

Man­u­fac­tur­ers may only make use of the extend­ed tran­si­tion peri­od under cer­tain con­di­tions. For exam­ple, man­u­fac­tur­ers must have for­mal­ly applied for MDR con­for­mi­ty assess­ment until May 26, 2024 and signed an agree­ment with an MDR des­ig­nat­ed noti­fied body for the con­for­mi­ty assess­ment until Sep­tem­ber 26, 2024.

In this con­text, noti­fied bod­ies must main­tain sur­veil­lance of the lega­cy devices. Con­fu­sion may come up if a man­u­fac­tur­er changes the noti­fied body in the tran­si­tion to the MDR. In this case, the guid­ance makes clear: “If the noti­fied body that issued the MDD or AIMDD cer­tifi­cate is not des­ig­nat­ed under the MDR, its respon­si­bil­i­ty for the appro­pri­ate sur­veil­lance will end on 25 Sep­tem­ber 2024, at the lat­est. No lat­er than 26 Sep­tem­ber 2024, the noti­fied body with which the man­u­fac­tur­er has signed the writ­ten agree­ment for MDR cer­ti­fi­ca­tion will be respon­si­ble to car­ry out this appro­pri­ate sur­veil­lance […].”

These and oth­er points are laid out and fur­ther explained in the doc­u­ment. Man­u­fac­tur­ers are rec­om­mend­ed to read the paper as it pro­vides clar­i­ty on cer­tain aspects of the tran­si­tion period.

Should you require the doc­u­ment or addi­tion­al advice, please don’t hes­i­tate to get in touch.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website