English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Section 1 General Provisions
Art. 6 Categorisation of clinical investigations
1 Clinical investigations fall into category A if: a. the device to be investigated carries a conformity marking in accordance with Article 13 MedDO; b. the device to be investigated is used in accordance with the instructions for use; and c. it is not prohibited to make the device to be investigated available on the market, put it into service or use it in Switzerland. 2 Category A clinical investigations are divided into sub-categories as follows: a. if 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: sub-category A1; b. if the participants undergo additional invasive or burdensome procedures compared to the procedures performed under the normal conditions of use of the device to be investigated: sub-category A2. 3 Clinical investigations fall into category C if: a. the device to be investigated carries a conformity marking in accordance with Article 1
Art. 6 — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 1 — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 1 let. a — SR 812.213 Para. 2 let. b — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 3 let. c — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294).
Art. 6a Categorisation of performance studies
1 Performance studies fall into category A if: a. an interventional performance study is involved and the following conditions are met (sub-category A1): 1. the device to be investigated carries a conformity marking in accordance with Article 12 IvDO, 2. the device to be investigated is used in accordance with the instructions for use, 3. it is not prohibited to make the device to be investigated available on the market, put it into service or use it in Switzerland, 4. none of the procedures stated in letter b point 2 are used; b. one of the following two conditions is met (sub-category A2): 1. a non-interventional performance study that is not covered by Article 2a paragraphs 1-3 is involved, 2. an interventional performance study in accordance with letter a points 1–3 is involved and: – surgically invasive procedures are used in order to collect biological material from the participants exclusively for the purpose of the performance study, or – the participants undergo additional inv
Art. 6a — Inserted 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 812.219
Art. 7 Exemption from mandatory approval
Category A clinical trials are exempt from the requirement to obtain approval from Swissmedic as set out in Article 54 paragraph 1 TPA.
Art. 8 Processing of data in electronic systems and information exchange
1 The sponsor shall use the following information systems for inputting and transmitting applications, notifications, reports and other information required under this Ordinance: a. the cantonal information system in accordance with Article 56a HRA for documents and information intended for the competent ethics committee; b. the medical devices information system in accordance with Article 62c HRA for documents and information intended for Swissmedic. 2 For inputting and transmitting decisions and for exchanging information with the applicants: a. Swissmedic shall use the medical devices information system in accordance with Article 62c TPA; b. the competent ethics committee shall use the cantonal information system in accordance with Article 56a HRA. 3 The medical devices information system in accordance with Article 62c TPA and the cantonal information system in accordance with Article 56a HRA may contain information on administrative or criminal proceedings or sanctions: a. concerni
Art. 8 — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 3 let. a — SR 812.213 Para. 3 let. a — SR 812.219
Art. 9 Information and coordination for approval procedures
The competent ethics committee and Swissmedic shall provide information to each other on the following aspects and coordinate their assessments: a. the categorisation of clinical trials in accordance Article 6 or 6a; b. aspects concerning the review areas in accordance with Article 11 and Article 17; c. the conduct of the procedures set out in Articles 12 and 19.
let. a — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). let. c — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323).
Section 2 Procedures to be performed by the Compet
Art. 10 Application
1 The sponsor shall submit the application documents specified in Annex 1. 2 The ethics committee may demand additional information. 3 The investigator may submit the application in place of the sponsor. In this case, the investigator assumes the obligations of the sponsor as set out in Articles 14 and 15 and the notification and reporting obligations to the competent ethics committee.
Para. 1 — Amended by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). Para. 3 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323).
Art. 11 Review areas
The areas to be reviewed by the ethics committee are governed mutatis mutandis by Article 25 ClinO.
Art. 11 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323). SR 810.305
Art. 12 Procedures and deadlines
1 The ethics committee shall confirm receipt of the application to the sponsor within 10 days and notify the sponsor of any formal deficiencies in the application documents. It shall give the sponsor 10 days to rectify the deficiencies and inform the sponsor that it shall not admit the application if the deficiencies are not rectified within this period. 2 It shall make its decision within 40 days of confirming receipt of the formally correct application documents. 3 If the ethics committee demands additional information in accordance with Article 10 paragraph 2, the 40-day period shall be paused until the information is received.
Art. 13 Multi-centre clinical trials
1 The sponsor shall submit the application for a multi-centre clinical trial in accordance with Article 47 paragraph 2 HRA to the ethics committee responsible for the coordinating investigator. The coordinating investigator may submit the application in place of the sponsor. Article 10 paragraph 3 applies mutatis mutandis. 2 The coordinating investigator is the individual with responsibility in Switzerland for coordinating the investigators responsible for the various trial sites. 3 The lead committee shall confirm receipt of the application to the sponsor within 10 days and notify it of any formal deficiencies in the application documents. It shall give the applicant 10 days to rectify the deficiencies and inform the applicant that it shall not admit the application if the deficiencies are not rectified within the deadline. On application, the lead committee may extend these deadlines by a period of five days in each case. 4 It shall notify the ethics committees responsible for the tr
Art. 14 Procedure for accompanying examinations involving ionising radiation
1 For accompanying examinations involving ionising radiation, the sponsor shall submit the additional application documents specified in Annex 1 number 4. The approval procedure is governed by Articles 10–13 and 15, subject to paragraphs 2–6. 2 The sponsor shall submit the additional application documents specified in Annex 1 number 5 if: a. a radiopharmaceutical employed is not used in accordance with the authorisation or is not authorised in Switzerland; b. a medical device employed which is capable of emitting ionising radiation: 1. is not used in accordance with the instructions for use, or 2. does not bear a conformity marking in accordance with Article 13 MedDO; or c. some other radioactive source is used. 3 The ethics committee shall forward the application documents to the FOPH in accordance with Annex 1 number 5. 4 The FOPH shall, within a reasonable period, deliver an opinion for the ethics committee on compliance with radiological protection legislation and on the dose estim
Art. 14 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323). Para. 2 let. b let. 2 — SR 812.213
Art. 15 Modifications
1 All modifications to an approved clinical trial that are likely to have a substantial impact on the safety, health or rights of the participants or on the robustness or reliability of the clinical data generated by the study (substantial modifications) must be approved by the ethics committee prior to their implementation. This obligation does not extend to measures that have to be taken immediately to protect the participants. 2 The sponsor shall submit the application documents specified in Article 10 paragraph 1 that are affected by the modification. The changes must be clearly marked. At the same time, the sponsor shall submit information on the reasons for and the nature of the modification. 3 The ethics committee shall issue its decision on substantial modifications within 30 days. Article 12 applies mutatis mutandis. 4 Where a further clinical trial site is to be added and that site lies outside the competence of the ethics committee that approved the clinical trial, the proce
Para. 1 — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 2 — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294).
Section 3 Approval Procedures to be performed by S
Art. 16 Application
1 The sponsor shall submit the application documents specified in Annex 1 number 2. 2 Swissmedic may request additional information. 3 If the sponsor withdraws its application for conformity-related clinical trials in sub-categories C1 and C2 before Swissmedic has made a decision, it shall inform the contracting states in which the clinical trial is being conducted or is due to be conducted.
Art. 17 Review areas
1 For clinical trials, Swissmedic shall verify: a. whether the application is complete; b. whether the requirements of Article 54 paragraph 4 letter b TPA are fulfilled. 2 It shall conduct a simplified review if the sponsor demonstrates the following in its application: a. the clinical trial involves: 1. a clinical investigation in sub-category C1 or C2 with a non-invasive device classified as class I or IIa under Article 15 MedDO, or 2. an interventional performance study in sub-category C1 or C2 with a device classified as class A or B under Article 14 IvDO. b. the use of the device to be investigated entails at most minimal risk for the trial participants; c. the investigator has signed a written agreement with the sponsor requiring the investigator to notify the sponsor without delay of serious adverse events or any other incident as specified in Article 32; d. the sponsor operates a risk management and safety monitoring system. 3 Swissmedic shall restrict its simplified review to
Para. 2 let. a — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 2 let. a let. 1 — SR 812.213 Para. 2 let. a let. 2 — SR 812.219
Art. 18 Clinical trials of devices capable of emitting ionising radiation
1 The additional application documents specified in Annex 1 numbers 4 and 5 must be submitted for category C clinical trials. 2 Swissmedic shall seek an opinion from the FOPH before it grants approval. The FOPH shall review compliance with radiological protection legislation and the dose estimation. 3 Swissmedic shall grant approval if: a. the requirements set out in Article 17 are fulfilled; and b. the FOPH has not submitted any objections to the clinical trial within a reasonable period. 4 It shall notify the FOPH of its decision.
Art. 18 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323). Para. 1 — Amended by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323).
Art. 19 Procedures and deadlines
1 Swissmedic shall confirm receipt of the application to the sponsor within 10 days and notify the sponsor of any formal deficiencies in the application documents. It shall give the sponsor 10 days to rectify the deficiencies and inform the sponsor that it shall not admit the application if the deficiencies are not rectified within this period. On request, Swissmedic may extend the period for rectifying the deficiencies by 20 days. 2 It shall make its decision within 45 days of confirming receipt of the formally correct application documents. It may only approve a clinical trial if the competent ethics committee has approved it beforehand. 3 Swissmedic shall also inform the contracting states if it rejects the application. 4 If a device is being used in humans for the first time or manufactured using a new process, Swissmedic may extend the period specified in paragraph 2 by no more than 20 days. It shall notify the sponsor of the extension. 5 If Swissmedic demands additional informati
Art. 20 Modifications
1 Substantial modifications to an approved clinical trial, in accordance with Article 15 paragraph 1, must be submitted to Swissmedic for approval prior to their implementation. This obligation does not extend to measures that have to be taken immediately to protect trial participants. 2 The sponsor shall submit to Swissmedic the application documents as specified in Article 16 paragraph 1 that are affected by the modification. The sponsor shall submit information on the nature of and reasons for the modifications at the same time. 3 Swissmedic shall make its decision within 38 days of receiving all the application documents affected by the modification. Article 19 applies mutatis mutandis. This period may be extended by seven days. 4 Other modifications applicable to the application documents submitted to Swissmedic must be notified to Swissmedic as quickly as possible. 4bis For conformity-related clinical trials in sub-categories C1 and C2 that are also being conducted, or are also d
Para. 4bis — Inserted by Annex No 1 of the O of 19 May 2021 (AS 2021 281). Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294).