The Med­ical Device Coor­di­na­tion Group (MDCG) has issued anoth­er guid­ance doc­u­ment, MDCG 2021-25.

The doc­u­ment pro­vides fur­ther guid­ance on cer­tain open ques­tions around how Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) applies to lega­cy devices. It includes an annex with a non-exhaus­tive table illus­trat­ing MDR require­ments that apply to lega­cy devices.

Although the doc­u­ment focus­es on the role of noti­fied bod­ies and their sur­veil­lance respon­si­bil­i­ties, it is a valu­able help for all eco­nom­ic oper­a­tors. For exam­ple, MDCG 2021-25 clar­i­fies that MDR require­ments not relat­ed to post-mar­ket sur­veil­lance, mar­ket sur­veil­lance, vig­i­lance, reg­is­tra­tion of eco­nom­ic oper­a­tors and devices should in prin­ci­ple not apply to eco­nom­ic oper­a­tors in respect to ‘lega­cy devices.’ 

This was not entire­ly clear when look­ing at the legal text of the MDR. As such, man­u­fac­tur­ers are rec­om­mend­ed to have a detailed look at the doc­u­ment to com­plete and sup­ple­ment their inter­pre­ta­tion of the MDR pro­vi­sions. Please let us know should you wish us to send you a copy. You may also vis­it our library sec­tion for addi­tion­al rel­e­vant documents.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing arti­cles on our website