EU HTA: MedTech Europe’s Recommendations for the Trilogue Negotiations

MedTech Europe, the trade association representing the medical technology industry in Europe, acknowledges the Council’s agreement to start trilogue negotiations on the proposed EU Regulation on Health Technology Assessment (HTA).

In this regard, we hereby make the following recommendations to the EU Institutions, to ensure that the trilogue negotiations on this proposed Regulation lead to equal and timely access to innovation across Europe, without leading to a redundant exercise that restricts access.

Three Key Recommendations for Striking the Right Balance in Joint Clinical Assessments conducted on Medical Technologies
1. Have predictable joint clinical assessments on selected medical technologies:
2. Ensure the new EU HTA framework in no way interferes with regulatory assessments conducted on medical technologies under the in vitro Diagnostic and Medical Device Regulations (IVDR/MDR)
3. Secure a pre-defined and clear purpose for how clinical assessment reports will be used, to meaningfully contribute to funding and/or investment decisions within the Member States.

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