The Euro­pean Com­mis­sion has unveiled a tar­get­ed reform of the Med­ical Device Reg­u­la­tion (MDR) and the In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR). The pro­pos­al direct­ly address­es struc­tur­al weak­ness­es that have emerged since the Reg­u­la­tions entered into force and sig­nals a clear shift towards a more pro­por­tion­ate, pre­dictable and inno­va­tion-friend­ly reg­u­la­to­ry frame­work, with­out com­pro­mis­ing patient safety.

Why this reform matters

While MDR and IVDR were designed to strength­en pub­lic health pro­tec­tion, their imple­men­ta­tion has revealed sig­nif­i­cant short­com­ings. Inef­fi­cient coor­di­na­tion mech­a­nisms, diver­gent inter­pre­ta­tions by noti­fied bod­ies and com­plex, cost­ly pro­ce­dures have neg­a­tive­ly impact­ed com­pet­i­tive­ness, inno­va­tion and, in some cas­es, patient access to essen­tial devices. Repeat­ed exten­sions of tran­si­tion­al peri­ods pro­vid­ed only tem­po­rary relief and did not resolve these struc­tur­al issues.

Key objec­tives of the Com­mis­sion proposal

The reform aims to sim­pli­fy applic­a­ble rules, reduce unnec­es­sary admin­is­tra­tive bur­den and increase the pre­dictabil­i­ty and cost-effi­cien­cy of con­for­mi­ty assess­ments, while main­tain­ing one of the high­est lev­els of med­ical device safe­ty glob­al­ly. Over­all cost sav­ings of around €3.3 bil­lion per year are expect­ed, includ­ing €2.4 bil­lion in admin­is­tra­tive savings.

What will change in practice

Faster mar­ket access: Clear time­lines for con­for­mi­ty assess­ments will be intro­duced to sup­port time­ly cer­ti­fi­ca­tion and reduce the risk of device shortages.

More pro­por­tion­ate require­ments: Con­for­mi­ty assess­ment pro­ce­dures will be stream­lined, par­tic­u­lar­ly for low- and medi­um-risk devices and those intend­ed for small patient populations.

Reduced noti­fied body involve­ment: For many Class IIa and IIb med­ical devices and Class B and C IVDs, tech­ni­cal doc­u­men­ta­tion assess­ment will focus on one rep­re­sen­ta­tive device per group or port­fo­lio. Class A ster­ile IVDs will no longer require noti­fied body involvement.

Clin­i­cal evi­dence made more effi­cient: A for­mal def­i­n­i­tion of well-estab­lished tech­nolo­gies will allow more pro­por­tion­ate evi­dence require­ments and increased use of real-world data where appro­pri­ate, includ­ing a more tar­get­ed and risk-based approach to post-mar­ket sur­veil­lance and post-mar­ket clin­i­cal fol­low-up reporting.

Adjust­ed clas­si­fi­ca­tion rules: Cer­tain devices, includ­ing reusable sur­gi­cal instru­ments, acces­sories to active implantable devices and some soft­ware prod­ucts, will be clas­si­fied into low­er risk classes.

PRRC require­ments sim­pli­fied: Detailed qual­i­fi­ca­tion require­ments will be removed. SMEs using exter­nal PRRCs will no longer need con­tin­u­ous avail­abil­i­ty, only appro­pri­ate availability.

Dig­i­tal­i­sa­tion and EU-lev­el coordination

Dig­i­tal­i­sa­tion is a cen­tral ele­ment of the reform. The pro­pos­al pro­motes elec­tron­ic instruc­tions for use (eIFU), dig­i­tal labelling and dig­i­tal con­for­mi­ty assess­ment pro­ce­dures. In par­al­lel, EU-lev­el coor­di­na­tion will be strength­ened. The Euro­pean Med­i­cines Agency (EMA) will sup­port reg­u­la­to­ry coor­di­na­tion, mon­i­tor poten­tial short­ages and main­tain a list of crit­i­cal med­ical devices.

What this means for SMEs

With around 90% of EU med­ical device man­u­fac­tur­ers being small and medi­um-sized enter­pris­es, the reform explic­it­ly tar­gets a reduc­tion of dis­pro­por­tion­ate reg­u­la­to­ry bur­den. Sim­pli­fied pro­ce­dures and clear­er rules are intend­ed to low­er mar­ket entry bar­ri­ers and improve legal cer­tain­ty for small­er manufacturers.

What hap­pens next

The pro­pos­al will now be dis­cussed by the Euro­pean Par­lia­ment and the Coun­cil. While amend­ments are like­ly, the direc­tion is clear: the EU is mov­ing towards a more risk-based, prag­mat­ic and eco­nom­i­cal­ly sus­tain­able reg­u­la­to­ry sys­tem. Man­u­fac­tur­ers should mon­i­tor devel­op­ments close­ly and pre­pare for changes that may affect clas­si­fi­ca­tion, con­for­mi­ty assess­ment strate­gies and reg­u­la­to­ry planning.

This arti­cle pro­vides a high-lev­el overview of the pro­posed MDR/IVDR reform. Fur­ther guid­ance and detailed imple­ment­ing acts are expect­ed as the leg­isla­tive process progresses.

Edi­tors note: This arti­cle was writ­ten in col­lab­o­ra­tion with Astra­Con.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website