On Friday, 28 August, the European Commission defended its proposal to simplify the European rules applicable to medical products and in vitro diagnostic products in response to a reasoned opinion from the French Senate challenging several aspects of the text in light of the principle of subsidiarity. The proposal, which was presented in December 2025 (see EUROPE 13773/7), should notably reduce the administrative burden weighing on manufacturers and make certification procedures more predictable.
In particular, the Senate had reproached the European Commission for having presented its text without an impact assessment, taking the view that [the institution] had not adequately demonstrated why intervention at the European level was necessary.
Faced with this criticism, the European Commission has cited the urgency of the difficulties that the sector has encountered and the targeted scope of the reform; it has also reminded the Senate that it carried out an evaluation in 2024 and 2025, including a public consultation, targeted consultations, document research, and expert opinions.
Another call for evidence was also launched in September 2025. In addition, two working documents presented the results of that evaluation and calculated the expected savings.
According to the European Commission, European intervention is justified, since the products concerned are governed by legislation that is directly applicable in all Member States and since separate national changes would risk creating divergences in the internal market.
It has also noted that the Senate is not contesting the chosen legal bases: Articles 114 and 168 of the Treaty on the Functioning of the European Union.
In another point of disagreement, the Senate challenged the proposed rules concerning interactions between the European database EUDAMED and national databases.
Yet, the European Commission has assured that these rules do not call into question States’ responsibility in organising their health systems but should prevent the same information from being reported several times. It has therefore rejected the argument that the principle of subsidiarity was violated.
Lastly, the European Commission defended the possibility of using delegated acts to amend several annexes to the regulations—an option that has also been challenged by the senators. [The institution] has reminded them that those powers would only concern non-essential elements and would remain subject to the supervision of the European Parliament and the Council of the EU. Finally, the European Commission explained that negotiations are ongoing in the European Parliament and the EU Council.
The European Commission’s response (in French): https://aeur.eu/f/n7r (Original version in French by Nithya Paquiry)