One of the main con­cerns when plan­ning towards com­pli­ance with Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) is the clin­i­cal evaluation.

Accord­ing to arti­cle 61 of the MDR, man­u­fac­tur­ers must con­duct a clin­i­cal eval­u­a­tion to con­firm the device’s con­for­mi­ty with the rel­e­vant gen­er­al safe­ty and per­for­mance require­ments. The clin­i­cal eval­u­a­tion shall be based on clin­i­cal data. 

In the course of the MDR tran­si­tion peri­od, the Med­ical Device Coor­di­na­tion Group (MDCG) issued a num­ber of guid­ance doc­u­ments to help man­u­fac­tur­ers inter­pret the MDR pro­vi­sions in an appro­pri­ate man­ner. Still, even with these doc­u­ments at hand, the clin­i­cal eval­u­a­tion process remains com­plex and challenging.

bsi has issued a white paper recent­ly that sum­ma­rizes the require­ments and guid­ance doc­u­ments and describes its inter­pre­ta­tion of the cor­re­spond­ing pro­vi­sions. The 21-page doc­u­ment is a valu­able tool to learn about the per­spec­tive of a noti­fied body on this cen­tral aspect of the MDR.

Should you wish to have a copy of the white paper for your ref­er­ences, please don’t hes­i­tate to get in touch.

Source: bsi 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website 

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