Medical Devices Ordinance (MedDO) (MedDO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 75 Principle
1 Inspections under the auspices of market surveillance shall cover devices made available on the market, conformity assessment procedures, device surveillance, device handling and economic operators’ fulfilment of their obligations. They shall also cover devices made available in contracting states by natural or legal persons domiciled in Switzerland, the conformity assessment procedures and surveillance activities for such devices and the natural or legal persons’ fulfilment of their obligations. 2 The market surveillance activities undertaken by Swissmedic and the Cantons are governed by Article 66 TPA and Articles 93–95, 97 and 98 EU MDR. Articles 97 paragraph 3 and 98 paragraphs 3 and 4 EU MDR are excluded. 3 The Cantons shall draw up annual plans for their market surveillance activities under paragraph 2. They shall provide Swissmedic with an annual summary of the results of their surveillance activities. Swissmedic may determine both the content of the summary and the form in wh
Para. 2 — See footnote to Art. 4 para. 1 let. f. Para. 2 — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291).
Art. 75a Common activities and use of information
1 The market surveillance authorities may reach agreement with organisations that represent the economic operators or users on the implementation of common activities designed to promote conformity and other similar purposes. 2 They may use all the information obtained in connection with these activities for market surveillance.
Art. 75a — Inserted by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291).
Art. 75b Additional measures
In addition to the measures stated in Article 75 paragraph 2, the competent authorities may institute the following measures in particular: a. They may require economic operators to issue the relevant information required to establish the ownership of websites, if the information concerned is connected with the subject of the investigation. b. They may request the removal of content from an online interface or the explicit display of a warning for users, provided there is no other option for eliminating a serious risk. c. If the request stated in letter b is ignored, they may instruct providers of information society services to restrict access to the online interface, for example by asking a third party to implement this measure. d. To protect public health, they may require a provider of information society services to discontinue its activities in Switzerland.
Art. 75b — Inserted by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291).
Art. 76 Responsibilities
1 Swissmedic is responsible for monitoring: a. devices and device conformity; b. vigilance; c. maintenance and reprocessing of devices: 1. in hospitals, 2. that are intended for use in hospitals. 2 Certain aspects of the monitoring activities set out in paragraph 1 remain the responsibility of other federal offices or institutions. 3 The Cantons are responsible for monitoring: a. the retail trade and dispensing points; b. the manual production of custom-made devices, of systems and of procedure packs; c. maintenance and reprocessing of devices by the professionals using them and in healthcare institutions with the exception of hospitals.
Art. 77 Powers
1 For the purposes of verifying conformity, the authorities responsible for monitoring under Article 76 may, without providing compensation: a. demand the proof and information required; b. take samples; c. have the samples tested or submitted to laboratory examination; d. enter and inspect, during normal working hours and with advance notice or, if necessary, unannounced, the business premises and facilities of natural or legal persons who have an obligation to provide information; e. consult documents and demand that they, or additional information, be provided in one of the official languages of Switzerland or in English. 2 If a manufacturer or a natural or legal person who assembles systems or procedure packs under Article 22 paragraphs 1 and 3 EU-MDR fails to fulfil their obligations under Article 66, Swissmedic may impose appropriate measures to protect health, up to and including prohibiting the making available on the market or the putting into service of the devices in questio
Para. 2 — See the footnote to Art. 4 para. 1 let. f. Para. 2 — Inserted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
Art. 78 Duty to cooperate and provide information
1 Economic operators that place a device on the market in Switzerland or in a contracting state, and economic operators, professionals and healthcare institutions that make a device available or put it into service in Switzerland or a contracting state have a duty to cooperate on matters of enforcement. In particular, they must provide, free of charge, all necessary information and all necessary proof and documentation to the enforcement bodies. 2 The providers of information society services also have a duty to cooperate on matters of enforcement. In particular, they should inform the competent authorities about suspected illegal activities by, or information from, users of their service and, upon request, provide information that enables the users of their service with whom they have concluded agreements about storage to be identified.
Para. 2 — Inserted by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291).
