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DRAFT BUDGETARY ASSESSMENT (COM(2025)1023 – C10-0360/2025 – 2025/0404(COD))

On the proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I

BUDG-PA-788813

Committee on Budgets · Rapporteur: Hélder Sousa Silva

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The Committee on Budgets gives its budgetary assessment of the proposed regulation amending rules on medical devices and in vitro diagnostic medical devices, and the European Medicines Agency's support for expert panels. It finds the proposal provides sufficient financial resources, with additional appropriations of EUR 62.610 million, and is compatible with the multiannual financial framework and own resources system. It supports 24 additional full-time equivalents for the Agency and 25 for the Commission's health directorate, and welcomes fee reductions for micro, small and orphan device manufacturers. It asks for fresh appropriations for new agency tasks, regular fee-level assessments, and clarification of how fees and the EU contribution cover the additional appropriations.

Committee position. The Committee on Budgets finds the proposal provides sufficient financial resources, supports the additional human resources for the Agency and the Commission, welcomes fee reductions for small and orphan device manufacturers, and asks for fresh appropriations for new tasks and clarification of the fee and EU contribution split.

Key points

  1. The Committee on Budgets carried out a budgetary assessment of the draft under Rule 58 of the Rules of Procedure.
  2. The proposal's estimated financial impact for 2028-2034 is EUR 42.065 million under Heading 2 and EUR 20.545 million under Heading 4.
  3. The proposal broadens the European Medicines Agency's mandate for scientific, technical and administrative support, secretarial work for expert panels and reporting on supply interruptions.
  4. The Agency is largely self-financed through industry fees, which were around 92 % of its general revenues in 2025.
  5. 88.7 % of the additional appropriations for the Agency will come from Union contributions and 11.3 % from fees.
  6. The Committee considers the proposal provides sufficient financial resources, with additional appropriations of EUR 62.610 million.
  7. It supports 24 additional full-time equivalents for the Agency: eight establishment plan posts and 16 contract agents.
  8. It says new tasks for decentralised agencies should be financed through fresh appropriations, with redeployments limited and examined carefully.
  9. It recommends reviewing the split between Union budget funding and fees during the annual budgetary procedure if the Agency collects more fee revenue.
  10. It notes that 25 full-time equivalents for the Commission's health directorate will be met by redeployments within the Commission.
  11. It welcomes fee reductions by notified bodies of 50 % for micro-enterprises, 25 % for small enterprises and at least 50 % for orphan devices.
  12. It calls for further clarification on the Legislative Financial and Digital Statement and says the statement must be revised if new responsibilities are granted.

Who is affected

  • The European Medicines Agency: gains a broadened mandate, 24 additional full-time equivalents and additional appropriations.
  • The Commission's Directorate-General for Health and Food Safety: receives 25 full-time equivalents through internal redeployments.
  • Micro-enterprises and small enterprises: benefit from notified body fee reductions of 50 % and 25 %.
  • Manufacturers of orphan medical devices: benefit from a fee reduction of at least 50 %.

Figures and deadlines

  • EUR 42.065 million of appropriations under Heading 2 for 2028-2034.
  • EUR 20.545 million of appropriations under Heading 4 for 2028-2034.
  • Around 92 % of the Agency's general revenues in 2025 came from industry fees.
  • 88.7 % of additional appropriations covered by Union contributions; 11.3 % by fees.
  • Additional appropriations amounting to EUR 62.610 million.
  • Occupancy rate of 99.79 % in 2025.
  • 24 additional full-time equivalents for the Agency: eight establishment plan posts and 16 contract agents.
  • 25 full-time equivalents for DG SANTE.