The EU allo­cat­ed €571 mil­lion ($664 mil­lion) for health projects under its 2025 EU4Health Pro­gramme, includ­ing €1.2 mil­lion for inno­v­a­tive orphan pedi­atric devices. Fund­ing is aimed at SMEs, NGOs, acad­e­mia, and sci­en­tif­ic soci­eties, with inter­est calls in Q3/Q4.

Chal­lenges and support

The EU lacks spe­cif­ic mar­ket access pro­vi­sions for orphan devices, with high reg­u­la­to­ry costs deter­ring inno­va­tion, espe­cial­ly pedi­atric devices. Sup­port for the pro­pos­al, inspired by the US FDA’s “Pae­di­atric Device Con­sor­tia Grants Pro­gram”, con­tin­ues fund­ing estab­lished in 2023.

Imple­ment­ing the deploy­ment of the EHDS

The dig­i­tal bud­get will fund the Euro­pean Health Data Space (EHDS), which aims to give indi­vid­u­als con­trol over their health data and allow reuse for research and inno­va­tion. Key ini­tia­tives include MyHealth@EU for cross-bor­der data exchange and HealthData@EU for mul­ti-coun­try access.

EU4Health fund­ing since 2021

The EU4Health pro­gram, launched in 2021 to strength­en health sys­tems against long-term chal­lenges, had its bud­get reduced in 2024 to €4.4 bil­lion after divert­ing €1 bil­lion to Ukraine. The pro­gram empha­sis­es cri­sis pre­pared­ness, health pro­mo­tion, dis­ease pre­ven­tion, health­care sys­tems, work­force, and dig­i­tal health, with a 2025 bud­get includ­ing €15 mil­lion from EEA and EFTA countries.

Pos­i­tive feed­back for focus on SMEs

The EU sup­ports SMEs in the device indus­try, espe­cial­ly through fund­ing for orphan devices. €4 mil­lion is allo­cat­ed for grants to assist SMEs with reg­u­la­to­ry and sci­en­tif­ic advice, includ­ing nav­i­gat­ing EU med­ical devices reg­u­la­tions (MDR and IVDR), as well as pre­clin­i­cal sci­en­tif­ic advice.

Antic­i­pat­ed results

The ini­tia­tive sup­ports SMEs in device devel­op­ment and reg­u­la­to­ry prepa­ra­tion, facil­i­tates con­for­mi­ty assess­ments, accel­er­ates mar­ket entry for inno­v­a­tive med­ical devices, and ensures time­ly patient access to safe devices. Ger­man indus­try asso­ci­a­tion BVMed sup­ports this ini­tia­tive and sug­gests that SMEs should qual­i­fy for reduced cer­ti­fi­ca­tion costs, sim­i­lar to the US FDA’s Med­ical Device User Fee Amend­ments (MDUFA), which reduces fees for small com­pa­nies by 50-75%. 

Source: Medtech Insight (an Infor­ma product)

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