The Euro­pean Med­i­cines Agency (EMA) is invit­ing EU-based man­u­fac­tur­ers or their autho­rised rep­re­sen­ta­tives to apply for a third phase of a pilot pro­gramme where expert pan­els pro­vide free sci­en­tif­ic advice for man­u­fac­tur­ers of high-risk med­ical devices. Man­u­fac­tur­ers are required to com­plete the sci­en­tif­ic appli­ca­tion form by 30th June 2024 to register.

Small and medi­um-sized enter­prise (SME) appli­ca­tions will receive spe­cial atten­tion to ensure their rep­re­sen­ta­tion in the pilot. The sci­en­tif­ic advice per­tains to pro­posed clin­i­cal devel­op­ment strate­gies and clin­i­cal inves­ti­ga­tion pro­pos­als for high-risk devices that fall into two cat­e­gories under the EU’s Reg­u­la­tion 2017/745 on med­ical devices (MDR), i.e. class III med­ical devices and class IIb active med­ical devices that are designed to admin­is­ter or remove med­i­c­i­nal prod­ucts from the body. 

The EMA is pri­ori­tis­ing appli­ca­tions that can cov­er var­i­ous med­ical areas and device types since the pilot phase only includes a lim­it­ed num­ber of sci­en­tif­ic device pro­ce­dures. In the first round, the expert pan­els select­ed six appli­ca­tions and con­cen­trat­ed on dis­ci­plines such as the cir­cu­la­to­ry sys­tem, orthopaedics, neu­rol­o­gy, and dentistry. 

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website