We commend the work of the rapporteur, Ms Cabezón Ruiz, and other Members of Parliament in reaching a balanced text.

We particularly support the strong role given to the Coordination Group which is now at the core of the process, being wholly responsible for the approval of joint clinical assessments and the definition of the common methodology.

A central role for competent authorities is essential to preserve the independence and quality of the scientific work and thus ensure broad trust in its outcomes. We also strongly support the choice made to maintain medical devices within the scope of the Regulation. We have consistently advocated a broad inclusion of these products, which would acknowledge and concretise the work realised by EUnetHTA so far. Provisions to make all documentation publicly available will ensure the necessary level of transparency to ensure stakeholders' trust in the process. 

However, we regret that the compromise reached introduces additional criteria and conditions compared to the original draft report of Ms Cabezón Ruiz which reduce the flexibility granted to Member States in performing complementary assessments deemed necessary in the context of their national appraisal procedures.

 ”Such flexibility is key to ensuring that mandatory uptake of joint assessments is acceptable for everyone. If the quality is sufficient, we see no reasons for Member States not to reuse the reports for their appraisal procedures”, assures Arnaud Emériau, ESIP President. “The compromise reached in the ENVI Committee significantly improves the original text of the European Commission, but some adjustments still need to be made”.

We hope the European Parliament's Plenary will swiftly adopt the report, paving the way for an agreement to be reached with the European Council.