English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 66 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 88–90, 92 and 93 EU-IVDR. Article 92 paragraph 3 and Article 93 paragraphs 3 and 4 EU-IVDR 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 f
Para. 2 — See the footnote to Art. 4 para. 1 let. e.
Art. 67 Common activities and use of information
[tab] 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. [tab] 2 They may use all the information obtained in connection with these activities for market surveillance.
Art. 68 Additional measures
[tab] In addition to the measures stated in Article 66 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. 69 Responsibilities
1 Swissmedic is responsible for monitoring: a. devices and device conformity; b. vigilance; c. the maintenance 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 maintenance of devices by the professionals using them and in healthcare institutions with the exception of hospitals.
Art. 70 Powers
1 For the purposes of verifying conformity, the authorities responsible for monitoring under Article 69 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 fails to fulfil its obligations under Article 59, 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 question.
Art. 71 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.
