The need for urgent reforms in the EU’s Med­ical Devices Reg­u­la­tion (MDR) has brought togeth­er indus­try lead­ers and pol­i­cy­mak­ers in a shared effort to stream­line the reg­u­la­to­ry process. Recent dis­cus­sions in late 2024 with­in the Coun­cil of the EU and the Euro­pean Par­lia­ment have high­light­ed grow­ing con­cerns over bureau­crat­ic hur­dles that delay approvals and sti­fle inno­va­tion in the med­ical tech­nol­o­gy sector.

Stake­hold­ers, includ­ing the Ger­man Med­ical Tech­nol­o­gy Asso­ci­a­tion (BVMed), have empha­sized the need for con­crete mea­sures to improve the cur­rent reg­u­la­to­ry frame­work. A pro­pos­al from France and Ger­many, sup­port­ed by nine mem­ber states, has emerged as a foun­da­tion for fur­ther dis­cus­sions. The main goal is to sim­pli­fy the MDR process, cre­ate a more cen­tral­ized reg­u­la­to­ry struc­ture, and reduce admin­is­tra­tive burdens.

One of the key sug­ges­tions is to give the Euro­pean Med­i­cines Agency (EMA) a stronger role in over­see­ing med­ical devices. BVMed sup­ports this idea but warns that any new process­es must avoid addi­tion­al bureau­cra­cy and costs. The asso­ci­a­tion also calls for bet­ter mon­i­tor­ing of noti­fied bod­ies, which are respon­si­ble for assess­ing and cer­ti­fy­ing med­ical devices. Ensur­ing con­sis­tent and trans­par­ent reg­u­la­tions across EU coun­tries is seen as a cru­cial step in cre­at­ing a more effi­cient system.

A major con­cern for the indus­try is the five-year re-cer­ti­fi­ca­tion require­ment for med­ical devices. BVMed argues that this rule adds unnec­es­sary admin­is­tra­tive strain with­out con­tribut­ing to patient safe­ty. How­ev­er, they pro­pose spe­cial reg­u­la­to­ry pro­ce­dures for orphan and pae­di­atric med­ical devices, which are often cru­cial for treat­ing rare conditions.

Momen­tum for reform increased in Octo­ber 2024, when the Euro­pean Par­lia­ment passed a res­o­lu­tion urg­ing imme­di­ate changes to MDR. The res­o­lu­tion calls for clear dead­lines for con­for­mi­ty assess­ments, stan­dard­ized fees for noti­fied bod­ies, and bet­ter sup­port for small and medi­um-sized enter­pris­es (SMEs). MedTech Europe, Europe’s main indus­try asso­ci­a­tion for med­ical tech­nol­o­gy, has echoed these con­cerns, warn­ing that reg­u­la­to­ry delays could hin­der inno­va­tion and lim­it patient access to life-sav­ing technologies.

With indus­try groups, nation­al gov­ern­ments, and EU insti­tu­tions large­ly aligned on the need for change, the focus is now shift­ing to imple­ment­ing real reforms. The first months of 2025 will be cru­cial as pol­i­cy­mak­ers work to trans­late these dis­cus­sions into leg­isla­tive actions that sim­pli­fy the reg­u­la­to­ry land­scape while main­tain­ing high stan­dards for patient safe­ty and device reliability.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website