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

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.