A new EU-fund­ed ini­tia­tive is explor­ing how dig­i­tal tools could make con­for­mi­ty assess­ments under the med­ical devices reg­u­la­tions (MDR and IVDR) more pre­dictable, effi­cient and eas­i­er to man­age for man­u­fac­tur­ers and noti­fied bodies.

Why this matters

Con­for­mi­ty assess­ment remains one of the most resource-inten­sive steps in bring­ing med­ical devices and in vit­ro diag­nos­tics to the Euro­pean mar­ket. Man­u­fac­tur­ers and noti­fied bod­ies often exchange large tech­ni­cal files across sev­er­al review cycles, using for­mats such as PDFs and spread­sheets. This can cre­ate delays, incon­sis­ten­cies and admin­is­tra­tive bur­den, par­tic­u­lar­ly for small and medi­um-sized enter­pris­es with lim­it­ed reg­u­la­to­ry capacity.

A sin­gle dig­i­tal route for submissions

The DIGICAP project, short for Dig­i­tal­i­sa­tion of the Con­for­mi­ty Assess­ment Process, is designed to test a more struc­tured way of han­dling MDR and IVDR assess­ments. Backed by €4 mil­lion in Hori­zon Europe fund­ing, the project will devel­op an open-source, ven­dor-neu­tral frame­work that uses machine-read­able data and stan­dard exchange formats.

What could change 

Instead of repeat­ing doc­u­ment exchanges across dis­con­nect­ed for­mats, man­u­fac­tur­ers may even­tu­al­ly use a sin­gle dig­i­tal entry point with pre­de­fined data fields, built-in com­plete­ness checks and clear­er sig­nals on miss­ing or incon­sis­tent information.

Who is involved

The con­sor­tium includes Team-NB, MedTech Europe, noti­fied bod­ies, research organ­i­sa­tions, pub­lic health experts, legal spe­cial­ists and reg­u­la­to­ry stakeholders. 

Test­ing the con­cept in practice

Planned pilots with man­u­fac­tur­ers and noti­fied bod­ies will assess whether the pro­posed approach improves usabil­i­ty, com­plete­ness and effi­cien­cy. The find­ings will help shape a prac­ti­cal roadmap for wider imple­men­ta­tion across the EU.

Out­look

DIGICAP is run­ning along­side wider EU dis­cus­sions on improv­ing the MDR and IVDR frame­works. If suc­cess­ful, it could sup­port a more trans­par­ent and pre­dictable con­for­mi­ty assess­ment path­way while help­ing Europe remain attrac­tive for med­ical tech­nol­o­gy development.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website