Amended by No I of the O of 7 June 2024, in force since 1 March 2025 (AS 2024 323).
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 41 Registration and data to be entered
1 The sponsor must register clinical trials in accordance with Article 64 paragraphs 1, 2, 3 and 4 and Article 66 ClinO and enter the relevant data. 2 The data to be entered under paragraph 1 shall be automatically published no later than six months after approval has been granted for the clinical trial on the portal specified in Article 67 ClinO.
Art. 41 — Amended by No I of the O of 7 June 2024, in force since 1 March 2025 (AS 2024 323). Para. 1 — SR 810.305
Art. 42 Publication of results
1 The sponsor must ensure that a summary of the trial results is entered and published in a recognised registry as specified in Article 64 paragraph 1 letter a or b ClinO within the following period: a. for completed clinical trials of devices that already bear a conformity marking and were used in accordance with the instructions for use, or in the event of a premature termination or interruption of a clinical trial: immediately after submitting the final report in accordance with Article 37; b. for all other completed clinical trials: at the latest before the device is placed on the market or one year after submitting the final report in accordance with Article 37 if the device has not been placed on the market by this point in time. 2 For the purpose of publication on the portal specified in Article 67 ClinO, the sponsor must additionally ensure that, within the period specified in paragraph 1, a lay summary of the trial results in accordance with Annex 5 number 2.15 ClinO is entere
Art. 42 — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Art. 42 — Amended by No I of the O of 7 June 2024, in force since 1 March 2025 (AS 2024 323). Para. 1 — SR 810.305 Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 March 2025 (AS 2024 323). Para. 2 — Inserted by No I of the O of 7 June 2024, in force since 1 March 2025 (AS 2024 323). Para. 3 — Inserted by No I of the O of 7 June 2024, in force since 1 March 2025 (AS 2024 323).