Over the past weeks, the Euro­pean Com­mis­sion pub­lished a num­ber of doc­u­ments that may be rel­e­vant for man­u­fac­tur­ers under Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices or in vit­ro diag­nos­tic med­ical devices (MDR or IVDR) respec­tive­ly depend­ing on the prod­uct scope.

Arti­cle 17, MDR:

The Com­mis­sion con­duct­ed a study on the state of affairs with regards to arti­cle 17 of the MDR, which reg­u­lates the repro­cess­ing of sin­gle-use devices in the Union. The study aimed to gath­er infor­ma­tion on the cur­rent sit­u­a­tion, major obsta­cles and relat­ed solu­tions. One of the main con­clu­sions from the study is that the cor­re­spond­ing pro­vi­sions have been imple­ment­ed in a frag­ment­ed man­ner through­out the Union, which increas­es com­plex­i­ty for stake­hold­ers. The report also lay­out a num­ber of rec­om­men­da­tions to com­pen­sate for these challenges. 

MDCG 2024-4:

The Med­ical Device Coor­di­na­tion Group (MDCG) pub­lished MDCG 2024-4. The doc­u­ment lays out the specifics for IVD man­u­fac­tur­ers that are con­duct­ing per­for­mance stud­ies and poten­tial­ly need to report adverse events in the con­text of these studies.

MDCG 2022-9, rev. 1:

The MDCG pub­lished an update to MDCG 2022-9. The doc­u­ment pro­vides a tem­plate for the Sum­ma­ry of Safe­ty and Per­for­mance (SSP) for IVD man­u­fac­tur­ers. Revi­sion 1 includes edi­to­r­i­al changes, but also gives addi­tion­al clar­i­fi­ca­tion when the SSP should be made avail­able to patients. 

MDCG 2024-5:

The MDCG pub­lished MDCG 2024-5. It pro­vides guid­ance on the con­tents of the Investigator’s Brochure in the con­text of clin­i­cal inves­ti­ga­tions con­duct­ed by med­ical device manufacturers.

Should you need any addi­tion­al advice or access to the doc­u­ments, please don’t hes­i­tate to get in touch or vis­it our down­load sec­tion directly.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website