The Euro­pean Commission’s Med­ical Device Coor­di­na­tion Group (MDCG) has recent­ly pub­lished a posi­tion paper on the tran­si­tion to Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR), which includes 19 pro­pos­als intend­ed to tack­le noti­fied body capac­i­ty prob­lems and con­cerns over the future short­age of some med­ical devices and IVD med­ical devices. 

Although the pro­pos­als are wide­ly appre­ci­at­ed, in view of the enor­mi­ty of the struc­tur­al prob­lems hold­ing the MDR and IVDR back, experts believe that the pro­pos­als are inad­e­quate and will not stop dis­rup­tion to the mar­ket. Speed is of the essence and res­o­lu­tions which can only be imple­ment­ed much lat­er will lead to loss of income because many MDD cer­tifi­cates are already begin­ning to expire.

For exam­ple, MedTech Europe says that there are sev­er­al solu­tions that involve noti­fied bod­ies doing things dif­fer­ent­ly with­out any real guidance. 

Sim­i­lar­ly, TEAM-NB says that the pro­pos­als are most­ly small­er solu­tions when it comes to mak­ing things eas­i­er for noti­fied bod­ies and that these will prob­a­bly not ensure suf­fi­cient noti­fied body capac­i­ty soon enough. TEAM-NB is also dis­sat­is­fied that the MDCG did not con­sid­er the association’s pro­pos­al to gen­er­al­ly per­mit devices with a valid cer­tifi­cate allot­ted under the for­mer direc­tives to remain on the EU mar­ket for an extra year after the expiry of the cer­tifi­cate. This would sup­port com­pe­tent author­i­ties con­fer­ring dero­ga­tions from applic­a­ble con­for­mi­ty assess­ments pro­ce­dures. It could also be applic­a­ble to devices for which man­u­fac­tur­ers can estab­lish that they have tak­en all real­is­tic steps to achieve tran­si­tion to the Reg­u­la­tions as set out in the notice to man­u­fac­tur­ers to ensure time­ly com­pli­ance with the MDR require­ments MDCG 2022-11.

Source: Medtech Insight (an Infor­ma prod­uct), Euro­pean Commission

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