English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 43 Updating of the annexes
The Federal Department of Home Affairs may update Annex 1 in line with international or technical developments. Where updates may pose technical barriers to trade, it shall effect such updates by mutual agreement with the Federal Department of Economic Affairs, Education and Research.
Art. 44 Amendment of other legislation
The amendment of other legislation is regulated in Annex 2.
Art. 45 Information on directly applicable legal acts of the European Commission
Swissmedic shall provide on its website information on legal acts of the European Commission that, under the terms of this Ordinance, are directly applicable in Switzerland in the version binding on the Member States of the European Union.
Art. 45 — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294).
Art. 46 Harmonisation of enforcement
1 Swissmedic and the ethics committees may prescribe electronic forms and technical procedures for inputting and transmitting documents and for sharing information in the electronic systems in accordance with Article 8. 2 For the purposes of enforcing this Ordinance, and particularly in providing electronic forms and aids to enforcement, Swissmedic and the ethics committees shall comply with the implementing acts and delegated acts adopted by the European Commission under Articles 70, 78 and 81 EU-MDR and Articles 66, 74 and 77 EU-IVDR, specifically in reference to: a. harmonised electronic forms for applications for clinical trials and their assessment, procedures to be performed by ethics committees and Swissmedic and for the coordinated assessment procedure; b. harmonised electronic forms for substantial modifications; c. harmonised electronic forms for reporting serious adverse events and device deficiencies; d. the exchange of information between the Member States and Switzerland
Para. 2 — See the footnote to Art. 4 para. 1 let. a. Para. 2 — See the footnote to Art. 2a para. 3. Para. 2 — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 2 let. f — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 2 let. g — Repealed by No I of the O of 4 May 2022, with effect from 26 May 2022 (AS 2022 294).
Art. 47 Cooperation with the European Commission and authorities of the contracting states
1 Where provided for by international agreements, Swissmedic shall cooperate with the European Commission and the authorities of the contracting states. 2 In doing so, Swissmedic shall involve the ethics committees in appropriate fashion where their area of responsibility is affected.
Art. 48 Transitional provisions for clinical trials approved under previous legislation and involving devices
1 Approvals for clinical trials of devices issued by the competent ethics committee and Swissmedic prior to the entry into force of this Ordinance shall remain valid until their expiry date. 2 The results of clinical trials of devices that are still in progress when this Ordinance enters into force have to be published in a recognised register in accordance with Article 64 paragraph 1 ClinO within the deadlines specified in Article 42. 3 Where clinical trials in accordance with paragraph 1 undergo substantial modifications, the sponsor must apply for categorisation under Article 6 at the same time.
Para. 2 — SR 810.305
Art. 48a Transitional provisions for performance studies approved prior to the entry into force of the amendment of 4 May 2022
If a clinical trial in accordance with Article 48 is a performance study, in the event of substantial modifications, the sponsor must also simultaneously apply for a categorisation in accordance with Article 6a.
Art. 48a — Inserted by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294).
Art. 48b Transitional provisions to the Amendment of 7 June 2024
For clinical trials of devices authorised before the Amendment of 7 June 2024 comes into force, with regard to liability and coverage requirements, Article 10 paragraphs 1 letter c in the version of 26 May 2022 and 2 and Articles 11–14 ClinO in the version of 1 January 2014 apply. If approval for the clinical trial was granted for a limited period, these requirements are governed by the amended law when the approval is renewed.
Art. 48b — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323). AS 2022 294 SR 810.305; AS 2013 3407 Correction of 17 Dec. 2024 (AS 2024 779).
Art. 49
Repealed by No I of the O of 4 May 2022, with effect from 26 May 2022 (AS 2022 294).
Art. 50 Commencement
1 Subject to the exceptions in paragraph 2, this Ordinance comes into force on 26 May 2021. 2 ...
Para. 2 — Repealed by No I of the O of 4 May 2022, with effect from 26 May 2022 (AS 2022 294).