Back­ground & pur­pose
The Med­ical Device Coor­di­na­tion Group (MDCG) pub­lished MDCG 2025-9 – Guid­ance on Break­through Devices (BtX) under Reg­u­la­tions 2017/745 & 2017/746. The doc­u­ment sets out cri­te­ria and a reg­u­la­to­ry path­way for des­ig­nat­ing so- called break­through med­ical devices and IVD med­ical devices to accel­er­ate safe patient access while bal­anc­ing pre- and post-mar­ket evi­dence oblig­a­tions. It aims to reduce unnec­es­sary delays for high-impact inno­va­tions and describe sup­ports avail­able to developers. 

This arti­cle pro­vides a brief sum­ma­ry of the main ques­tions that are answered by the guid­ance below. mdi Europa will poten­tial­ly pro­vide a more detailed analy­sis in the future. Should you have any ques­tions or com­ments, please don’t hes­i­tate to get in touch.

Main points
• Cri­te­ria: Under which con­di­tions is a device rec­og­nized as a BtX?
• Evi­dence: What are the pre-clin­i­cal, clin­i­cal and per­for­mance require­ments for a BtX and what PMS pro­vi­sions apply?
• Pro­ce­dur­al routes: What are the reg­u­la­to­ry routes to bring a BtX to mar­ket and how are expert pan­els, noti­fied bod­ies and com­pe­tent author­i­ties involved?
• Sup­port mea­sures: What fund­ing mech­a­nisms are in place?

Source: MDCG 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website