Prod­uct lia­bil­i­ty directive

In our March arti­cle, we have report­ed that a change of the prod­uct lia­bil­i­ty direc­tive was immi­nent. One of the core changes was an eas­i­er process for con­sumers to make claims against man­u­fac­tur­ers. The revised direc­tive was pub­lished in the Offi­cial Jour­nal of the EU on Novem­ber 18 and will thus enter into force on Decem­ber 8 + 20 days.

MDCG 2024-14

The Med­ical Device Coor­di­na­tion Group (MDCG) issued MDCG 2024-14, Guid­ance on the imple­men­ta­tion of the Mas­ter UDI-DI solu­tion for con­tact lens­es. It pro­vides guid­ance on imple­ment­ing the Mas­ter UDI-DI sys­tem for con­tact lens­es. This sys­tem aims to sim­pli­fy reg­u­la­to­ry require­ments by group­ing prod­ucts with sim­i­lar design para­me­ters under a sin­gle iden­ti­fi­er. It applies to both stan­dard and made-to-order lens­es, detail­ing how attrib­ut­es like base curve, diam­e­ter, and oth­er design para­me­ters should be used to define Mas­ter UDI-DI assign­ments. The guid­ance clar­i­fies label­ing require­ments and ensures com­pli­ance with the Med­ical Devices Reg­u­la­tion (MDR) while min­i­miz­ing admin­is­tra­tive com­plex­i­ty for man­u­fac­tur­ers and regulators​. The doc­u­ment can be found in our Library section. 

MDCG 2024-15

The MDCG issued MDCG 2024-15, Guid­ance on the pub­li­ca­tion of the clin­i­cal inves­ti­ga­tion reports and their sum­maries in the absence of EUDAMED. The MDR requires that spon­sors sub­mit to rel­e­vant EU mem­ber states a clin­i­cal inves­ti­ga­tion report and sum­ma­ry via EUDAMED. The guid­ance doc­u­ment pro­vides clar­i­fi­ca­tion on how reports must be sub­mit­ted in the absence of EUDAMED. Also, it explains how doc­u­ments will be labelled, man­aged and stored. A key point is that reports and sum­maries are stored in a cen­tral repos­i­to­ry, i.e. a ded­i­cat­ed pub­lic “CIRCABC” space. The doc­u­ment can be found in our Library section.

MDCG 2024-16

The MDCG issued MDCG 2024-16, Man­u­fac­tur­er Infor­ma­tion Form on Inter­rup­tion or Dis­con­tin­u­a­tion of Sup­ply of cer­tain med­ical devices and cer­tain in vit­ro diag­nos­tic med­ical devices. The doc­u­ment fol­lows the amend­ing Reg­u­la­tion (EU) 2024/1860. As described in our Novem­ber newslet­ter issue, it intro­duced under arti­cle 10a of Reg­u­la­tions (EU) 2017/745 and 2017/746 (MDR and IVDR) the oblig­a­tion of eco­nom­ic oper­a­tors to alert com­pe­tent author­i­ties and the mar­ket in the case of inter­rup­tion or dis­con­tin­u­a­tion of the sup­ply chain for cer­tain devices. MDCG 2024-16 pro­vides a report form that eco­nom­ic oper­a­tors should use when short­age of cer­tain devices becomes vis­i­ble. The doc­u­ment can be found in our Library section.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website