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

for the Committee on Public Health 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

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

The Committee on Budgets has carried out a budgetary assessment of the draft under Rule 58 of the Rules of Procedure and has reached the following conclusions:

The Committee on Budgets,

–having regard to Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union1,

–having regard to Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 20272,

A.whereas the estimated financial impact of the proposal for the period 2028-2034 amounts to EUR 42.065 million of appropriations under Heading 2, and EUR 20.545 million of appropriations under Heading 4;

B.whereas the mandate and tasks of the European Medicines Agency (EMA – ‘the Agency’) have continuously evolved since its establishment in 1993;

C.whereas this proposal aims to further broaden EMA’s mandate and enable it to effectively perform its additional tasks with regard to its scientific, technical and administrative support to national competent authorities, its secretarial role for expert panels for medical devices and the reporting on the possible interruption or discontinuation of the supply of certain medical devices;

D.whereas EMA is a largely self-financed agency, funded primarily through fees charged to industry, supplemented by a balancing contribution from the EU;

E.whereas the Agency is currently operating under a universal budgeting model, where revenues from fees charged to industry and the balancing contribution from the EU are not separated, possibly creating cross-subsidisation between the two;

F.whereas the fees charged to industry represented around 92 % of the Agency’s general revenues in 2025;

G.whereas 88.7 % of the additional appropriations for EMA foreseen in this proposal will be covered by Union contributions and only 11.3 % by fees paid to the Agency;

H.whereas additional human resources are foreseen for the Commission’s Directorate-General for Health and Food Safety (DG SANTE);

I.whereas this proposal intends to introduce a fee reduction granted by notified bodies for micro and small manufacturers and for orphan medical devices;

1.Insists on the adequacy between tasks and resources; considers at this stage that the proposal provides for sufficient financial resources for the planned changes with additional appropriations amounting to EUR 62.610 million;

2.Takes note of the Agency’s improved recruitment performance with an occupancy rate of 99.79 % in 20253;

3.Insists that the additional tasks for the Agency be met with sufficient financial and human resources; supports, in this regard, the request for additional human resources for EMA amounting to 24 additional full-time equivalents (FTEs) comprising eight establishment plan posts and 16 contract agents (CAs);

4.Reiterates that any new tasks entrusted to decentralised agencies should be financed through fresh appropriations, and that redeployments from other programmes and priorities should be limited and examined with due care;

5.Underlines the importance of regular assessments of the fee level, taking into account the evolution of costs in line with the Framework Financial Regulation for decentralised EU agencies4;

6.Recommends that if the Agency collects additional fee revenue as a result of its broadened mandate, the proportion of funding provided by the Union budget and by fees to cover the additional appropriations for EMA should be reviewed during the annual budgetary procedure;

7.Notes that the appropriations required for additional human resources in DG SANTE, comprising 25 FTEs, will be met by redeployments within the Commission under the annual budgetary procedure; insists that the allocation of additional human resources adequately reflect the additional tasks resulting from this Commission proposal;

8.Welcomes the fee reduction granted by notified bodies to micro-enterprises and small enterprises within the meaning of Recommendation 2003/361/EC of 50 % and 25 %, respectively, and the fee reduction for manufacturers that apply for a conformity assessment of an orphan device of at least 50 %;

9.Stresses that any form of fee reduction must not undermine the Agency’s sound financial management;

10.Calls for further clarifications to be made to the European Parliament on the Legislative Financial and Digital Statement (LFDS) regarding the proportion of appropriations covered by fees and the EU contribution, respectively;

11.Stresses that, should additional responsibilities be granted to the Agency or the Commission in the course of the negotiations, their financial implications will be assessed and the LFDS accompanying the proposal will have to be revised accordingly, ensuring that the financial and human resources of the legislative proposal match the tasks entrusted to the Agency or the Commission;

12.Determines that the proposal is compatible with the multiannual financial framework and the system of own resources, as well as with the interinstitutional agreement and the budgetary principles laid down in the Financial Regulation5.

As part of its budgetary assessment, the Committee on Budgets also submits the following amendments to the draft:

Amendment 1

Proposal for a regulation

Recital 59 a (new)

Or. en