The Euro­pean Com­mis­sion has launched a new pilot pro­gram to improve coor­di­na­tion among EU mem­ber states for review­ing clin­i­cal inves­ti­ga­tions under the Med­ical Devices Reg­u­la­tion (MDR) and per­for­mance stud­ies under the In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR). This ini­tia­tive aims to sim­pli­fy and speed up the approval process, reduce costs, and cre­ate a more trans­par­ent and con­sis­tent eval­u­a­tion sys­tem for med­ical device studies.

The pro­gram allows spon­sors to sub­mit a sin­gle appli­ca­tion that will be reviewed by mul­ti­ple mem­ber states simul­ta­ne­ous­ly. This stream­lined approach is designed to har­mo­nize reg­u­la­to­ry inter­ac­tions across Europe, ensur­ing that appli­ca­tions are processed more effi­cient­ly. The ini­tia­tive fol­lows Arti­cle 78 of the MDR and Arti­cle 74 of the IVDR, which empha­size the need for coor­di­nat­ed assessments.

By join­ing the pro­gram, spon­sors can ben­e­fit from improved com­mu­ni­ca­tion between reg­u­la­to­ry bod­ies, more pre­dictable eval­u­a­tions, reduced admin­is­tra­tive bur­den, and a faster over­all approval process. How­ev­er, eli­gi­bil­i­ty is lim­it­ed to cer­tain types of devices. Under the MDR, only class III, IIa, and IIb inves­ti­ga­tion­al devices qual­i­fy, while under the IVDR, eli­gi­ble per­for­mance stud­ies must involve com­pan­ion diag­nos­tics, or patient man­age­ment deci­sions, treat­ment guid­ance, or addi­tion­al sub­ject risks.

A total of 20 mem­ber states—including Ger­many, France, Italy, and Spain—are par­tic­i­pat­ing in the pilot. Infor­ma­tion about asso­ci­at­ed fees and ethics approvals can be found on the Euro­pean Commission’s web­site. The Med­ical Device Coor­di­na­tion Group’s Clin­i­cal Inves­ti­ga­tion and Eval­u­a­tion Work­ing Group will con­tin­u­ous­ly review appli­ca­tions based on eli­gi­bil­i­ty and pub­lic health impact. Spon­sors inter­est­ed in includ­ing a non-par­tic­i­pat­ing coun­try must apply sep­a­rate­ly at the nation­al level.

The pro­gram is open for appli­ca­tions until June 30, 2025. To assist spon­sors through­out the process, a ded­i­cat­ed sec­re­tari­at is avail­able for inquiries via email at SANTE-CACIPS@ec.europa.eu.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website