With the new Reg­u­la­tions (EU) 2017/745 and (EU) 2017/746 on med­ical devices (MDR) and in vit­ro diag­nos­tic med­ical devices (IVDR) replac­ing the Med­ical Devices Direc­tive 93/42/EEC (MDD), the Active Implantable Med­ical Devices Direc­tive 90/385/EEC (AIMDD) and the In Vit­ro Diag­nos­tic Med­ical Devices Direc­tive 98/79/EC (IVDD), the prin­ci­ple of CE Mark­ing remains the same!

Read here, what is required to obtain the CE Mark for med­ical devices

Whether a Noti­fied Body was involved or not, every man­u­fac­tur­er has to ful­fill the Gen­er­al Safe­ty and Per­for­mance Require­ments (SPR) in accor­dance with annex I and set up the Tech­ni­cal Doc­u­men­ta­tion accord­ing to annex­es II and III. Final­ly, every man­u­fac­tur­er has to com­plete a Dec­la­ra­tion of Con­for­mi­ty in accor­dance with annex IV of the MDR or IVDR respec­tive­ly. Man­u­fac­tur­ers that are not locat­ed in the EU are oblig­ed to apply for CE Mark­ing via an Autho­rized Rep­re­sen­ta­tive in accor­dance with arti­cle 11 of the MDR and IVDR. 

Also, final com­pli­ance with the Direc­tives and Reg­u­la­tions does not mean that the fin­ish­ing line has been crossed. 

Also, final com­pli­ance with the Direc­tives and Reg­u­la­tions does not mean that the fin­ish­ing line has been crossed. Stan­dards are revised con­stant­ly and those man­u­fac­tur­ers who do not active­ly take part in these revi­sions will find it impos­si­ble to keep up to date. 

Upcom­ing changes towards the MDR / IVDR

The MDR and IVDR rep­re­sent a shift from a pre-approval to a life-cycle approach. For exam­ple, data gen­er­at­ed through post-mar­ket sur­veil­lance must feed back into a man­u­fac­tur­ers risk man­age­ment and clin­i­cal eval­u­a­tion. Essen­tial parts of the Tech­ni­cal Doc­u­men­ta­tion must be updat­ed reg­u­lar­ly. Please see the cor­re­spond­ing sec­tion below and fol­low the links for fur­ther details. (Many of these points are also list­ed under “CE Mark­ing” in the main navigation.)

Fun­da­men­tal as well as up to date infor­ma­tion on CE Mark­ing and CE Mark­ing approval process in full depth