Article 16 · Commission Implementing Regulation (EU) 2025/2086

Contents

Article 16Draft joint clinical assessment and summary reports#

1.The assessor, with the assistance of the co-assessor, shall prepare the draft joint clinical assessment report using the template set out in Annex III for medical devices and the template set out in Annex IV for in vitro medical devices, and summary report using the template set out in Annex V. At any time during the preparation of the draft joint clinical assessment and summary reports, the assessor and co-assessor, via the HTA secretariat, may seek input from the individual experts selected in accordance with Article 8. The HTA secretariat shall make that input available to the entire JCA Subgroup without delay.

2.The HTA secretariat shall share the draft joint clinical assessment and summary reports prepared by the assessor, with the assistance of the co-assessor, for comments with the JCA Subgroup without delay. After having considered the comments from the members of the JCA Subgroup and any input from the individual experts referred to in paragraph 1, the assessor, with the assistance of the co-assessor, shall prepare the revised draft joint clinical assessment and summary reports.

3.The HTA secretariat shall share the revised draft joint clinical assessment and summary reports with the individual experts selected in accordance with Article 8 and give them the opportunity to provide input on the revised draft joint clinical assessment and summary reports.

4.The HTA secretariat shall provide the revised draft joint clinical assessment and summary reports to the health technology developer. The health technology developer shall indicate any purely technical or factual inaccuracies and any information it considers to be confidential within 7 days from the date on which it received the revised draft joint clinical assessment and summary reports. The health technology developer shall demonstrate the commercially sensitive nature of the information it considers to be confidential.

5.Where the health technology developer submits new clinical data on its own initiative as provided for in Article 11(2) of Regulation (EU) 2021/2282, the JCA Subgroup shall make its best efforts in order that the new clinical data is considered in the joint clinical assessment report. Where the new clinical data is received no later than 60 days after the Commission’s confirmation that the dossier meets the requirements laid down in Article 9(2), (3) and (4) of Regulation (EU) 2021/2282, the JCA Subgroup shall ensure that the new clinical data is considered in the joint clinical assessment report.