Tran­si­tion time­lines con­nect­ed to Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) have become a com­plex issue. Back in March, Reg­u­la­tion (EU) 2023/607 became applic­a­ble thus intro­duc­ing – among oth­ers – new tran­si­tion time­lines for MDR lega­cy devices.

Please find below a brief sum­ma­ry of the most recent updates on the afore­men­tioned topic.

Revi­sion 1 of doc­u­ment Q&A on prac­ti­cal aspects relat­ed to the imple­men­ta­tion of Reg­u­la­tion (EU) 2023/607 amend­ing Reg­u­la­tions (EU) 2017/745 and (EU) 2017/746 as regards the tran­si­tion­al pro­vi­sions for cer­tain med­ical devices and in vit­ro diag­nos­tic med­ical devices has been pub­lished with fur­ther clar­i­fi­ca­tion and spec­i­fi­ca­tion. We will issue a sep­a­rate newslet­ter arti­cle shortly.

The Euro­pean Com­mis­sion has updat­ed its Fact­sheet for author­i­ties in non-EU/EEA states on med­ical devices and in vit­ro diag­nos­tic med­ical devices to help com­pe­tent author­i­ties out­side the Union to under­stand the pro­vi­sions of the extend­ed tran­si­tion peri­od. We will issue a sep­a­rate newslet­ter arti­cle shortly.

The Euro­pean Com­mis­sion has pub­lished a flow­chart Con­di­tions and dead­lines for plac­ing ‘lega­cy devices’ and class III cus­tom-made implantable devices on the mar­ket or putting them into ser­vice in accor­dance with Arti­cle 120 MDR, as amend­ed by Reg­u­la­tion 2023/607 to help involved actors to under­stand if med­ical devices can make use of the extend­ed tran­si­tion peri­od. Please let us know should you need the flow­chart doc­u­ment or require assis­tance in under­stand­ing the under­ly­ing requirements.

Man­u­fac­tur­ers that may make use of the extend­ed tran­si­tion peri­od, should be able to present a self-dec­la­ra­tion and – depend­ing on the type of lega­cy device – a dec­la­ra­tion issued by the noti­fied body. The cor­re­spond­ing asso­ci­a­tions and indus­try groups have set up tem­plates that cor­re­spond to the require­ments. Should you need one of the tem­plates, please let us know.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website