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Section 1 Subject Matter, Definitions and Applicab
Art. 1 Subject matter
1 This Ordinance shall regulate: a. the requirements pertaining to clinical trials: 1. of medical devices and other devices in accordance with Article 1 of the Medical Devices Ordinance of 1 July 2020 (MedDO), 2. of in vitro diagnostic medical devices and their accessories in accordance with Article 1 paragraph 1 of the Ordinance of 4 May 2022 on In Vitro Diagnostic Medical Devices (IvDO); b. the approval and notification procedures for clinical trials involving the devices in accordance with letter a; c. the duties and responsibilities of research ethics committees (ethics committees), the Swiss Agency for Therapeutic Products (Swissmedic) and the Federal Office of Public Health (FOPH) in connection with the approval and notification procedures; d. the registration of clinical trials involving devices in accordance with letter a; e. public access to information concerning clinical trials. 2 In this Ordinance, the term devices is used to designate all products defined in paragraph 1 le
Para. 1 let. a — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 1 let. a let. 1 — SR 812.213 Para. 1 let. a let. 2 — SR 812.219
Art. 2 Definitions
In this Ordinance: a. clinical trial means a clinical investigation and a performance study; abis. clinical investigation means any systematic investigation involving one or more persons undertaken to assess the safety or performance of the device in accordance with the MedDO; ater. performance study means a study undertaken to establish or confirm the analytical or clinical performance of a device in accordance with the IvDO and in which the test results: 1. may influence patient management decisions or treatment (interventional performance study), 2. cannot influence patient management decisions or treatment (non-interventional performance study); b. conformity-related clinical trial means a clinical trial conducted to demonstrate the conformity of the device being investigated; c. contracting state means any state that is bound to mutually recognise conformity assessments and conformity procedures for devices by an agreement with Switzerland under international law based on equivale
let. a — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). let. abis — Inserted by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). let. abis — SR 812.213 let. ater — Inserted by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). let. ater — SR 812.219
Art. 2a Exceptions from the scope
1 The conduct of non-interventional performance studies is governed by Chapter 2 of the Human Research Ordinance of 20 September 2013 (HRO) when: a. biological material is collected from the participants without a surgically invasive procedure; or b. the participants do not undergo additional invasive or burdensome procedures compared to the procedures performed under the normal conditions of use of the device to be investigated. 2 The conduct of non-interventional performance studies in which only already sampled biological material or already collected health-related personal data are further used is governed by Chapter 3 of the HRO. 3 The conduct of non-interventional performance studies in which only already sampled anonymised biological material or already collected anonymised health-related data are further used is governed by Articles 3 and 4 of the Ordinance of 20 September 2013 on Clinical Trials (ClinO), Article 25 HRO and Article 57 of Regulation (EU) 2017/746 (EU-IVDR). 4 T
Art. 2a — Inserted by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 1 — SR 810.301 Para. 3 — SR 810.305 Para. 3 — Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2020/227/EU, OJ L 117 of 5.5.2017, p. 176; last amended by Regulation (EU) 2023/607, OJ L 80 of 20.3.2023, p. 24. Para. 3 — Amended by Annex No 1 of the O of 29 Sept. 2023,
Art. 3 Applicable provisions
1 The following provisions of the Ordinance of 20 September 2013 on Clinical Trials in Human Research (ClinO) apply to clinical trials of devices: a. for scientific integrity, scientific quality and the inclusion of relevant groups of persons: Articles 3, 4 and 4a ClinO; b. for participant information, consent, communication of results and revocation of consent: Articles 7–9 ClinO; c. for liability and coverage: Article 10 paragraph 1 letter c mutatis mutandis and Articles 10 paragraph 2 and 11–14 ClinO; d. for the conduct of clinical trials in emergency situations: Articles 15–17 ClinO; e. for the storage of health-related personal data and biological material, and for the handling of genetic data in connection with insurance matters: Articles 18 and 18a ClinO; f. for inspections and administrative measures: Article 46 paragraphs 1, 2, 4 and 5 and Articles 47 and 48 ClinO. 2 The powers exercised by Swissmedic and the duty to cooperate and provide information incumbent on the sponsor a
Para. 1 — SR 810.305 Para. 1 let. a — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323). Para. 1 let. b — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323). Para. 1 let. c — Correction of 20 May 2025 (AS 2025 326). Para. 1 let. e — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323). Para. 2 — SR 812.213 Para. 2 — SR 812.219 Para. 2 — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (A
Section 2 General Obligations of the Sponsor and I
Art. 4 General obligations of the sponsor and investigator
1 The sponsor and investigator must fulfil: a. for clinical investigations: the requirements in accordance with Article 72 and Annex XV Chapters I and III of Regulation (EU) 2017/745 (EU-MDR); b. for performance studies: the requirements in accordance with Article 68 and Annex XIII Part A of EU-IVDR. 2 Compliance with the requirements of paragraph 1, specified in greater detail by designated technical standards or common specifications in accordance with Article 9 paragraph 1 EU-MDR or Article 9 paragraph 1 EU-IVDR, is presumed if the clinical trial is conducted in accordance with those standards or specifications. Article 6 paragraph 5 MedDO and Article 6 paragraph 4 IvDO apply mutatis mutandis. 3 If the sponsor is not domiciled in Switzerland and does not have a place of business there, it must designate an agent that is domiciled or has a place of business in Switzerland as an address for correspondence. This agent must ensure compliance with the sponsor’s obligations.
Para. 1 let. a — Amended by Annex No 1 of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576). Para. 1 let. a — Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, OJ L117 of 5.5. 2017, p. 1, last amended by Regulation (EU) 2023/607, OJ L 80 of 20.3.2023, p. 24. Para. 1 let. b — S
Art. 5 Professional qualifications
1 Clinical trial investigators must: a. be entitled to practise under their own professional responsibility as physicians or in another profession that specifically qualifies them to conduct the clinical trial; b. demonstrate adequate knowledge of the internationally recognised requirements for the conduct of clinical trials and the specialist knowledge and experience required for the clinical trial; c. possess knowledge of the legal requirements governing clinical trials or be able to guarantee the availability of such knowledge by consulting appropriate expertise; and d. have appropriate knowledge and skills in the areas of data security and data protection or be able to ensure compliance by calling in appropriate expertise. 2 Other persons conducting the clinical trial must possess the training or experience in the specialist field that is required to conduct clinical trials.
Para. 1 let. d — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323).