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 Requirements
Art. 6 General safety and performance requirements
1 A device may be placed on the market or put into service only if it complies with this Ordinance when duly supplied and properly installed, maintained and used in accordance with its intended purpose. 2 Devices shall meet the general safety and performance requirements set out in Annex I to EU-IVDR, taking into account its intended purpose. 3 If the device complies with the applicable technical standards or common specifications designated by the Swiss Agency for Therapeutic Products (Swissmedic), or relevant sections thereof, or with pharmacopoeial requirements in accordance with the Pharmacopoeia Ordinance of 17 October 2001, then the device shall be presumed to comply with those requirements of this Ordinance covered by the applicable designated technical standards or common specifications, or relevant sections thereof, or by the pharmacopoeial requirements. 4 The presumption in paragraph 3 also applies to compliance with the system or process requirements to be fulfilled in accor
Para. 2 — See the footnote to Art. 4 para. 1 let. e. Para. 3 — SR 812.211
Art. 7 Distance sales
1 Devices offered in Switzerland by means of information society services – specifically an online service – that fulfil the conditions set out in paragraph 5 must comply with this Ordinance. 2 Devices offered to users in Switzerland online or via some other form of distance sales are considered to have been made available on the market. 3 Similarly, devices although not placed on the market, but used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services or by other means of communication shall also comply with this Ordinance. 4 Upon request by the Swiss Agency for Therapeutic Products (Swissmedic), any natural or legal person offering diagnostic or therapeutic services in accordance with paragraph 1 shall make available a copy of the declaration of conformity. 5 A device is deemed to be supplied via an information society service if that service
Art. 8 Specific requirements
Devices that are also machines within the meaning of Article 1 of the Machine Ordinance of 2 April 2008 must satisfy the relevant general safety and health protection requirements of the Machine Ordinance where these requirements are more specific than those of Chapter II of Annex I to EU-IVDR.
SR 819.14 See the footnote to Art. 4 para. 1 let. e.
Art. 9 Devices manufactured and used in healthcare institutions
1 Devices manufactured and used solely within healthcare institutions, with the exception of devices for performance studies, are deemed to have been put into service. Such devices are subject to the pertinent general safety and performance requirements of Annex I EU-IVDR, but not to any of the other requirements set out in this Ordinance, provided the requirements of Article 5 paragraph 5 letters a–i EU-IVDR are fulfilled. 2 The documentation specified in Article 5 paragraph 5 letter g EU-IVDR is required for devices of all classes in accordance with Article 14. 3 Paragraphs 1 and 2 do not apply to devices manufactured on an industrial scale.
Para. 1 — See the footnote to Art. 4 para. 1 let. e.
Art. 10 Notification of devices manufactured in healthcare institutions
1 Healthcare institutions that manufacture and use devices as specified in Article 9 shall provide the following information to Swissmedic prior to putting the devices into service: a. their name and address; b. the name and intended purpose of the device; c. the risk class of the device in accordance with Article 14. 2 Any other relevant information about these devices must be submitted to Swissmedic upon request. 3 Changes to the information required in paragraph 1 must be reported to Swissmedic within 30 days. 4 Depending on the risk inherent to a device and its use, Swissmedic may exempt devices manufactured and used in accordance with Article 9 from the reporting obligation.
Art. 11 Parts and components
1 Any natural or legal person who makes available on the market an item intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence must be kept available for the competent authority. 2 An item that is intended to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Ordinance.
Art. 12 Conformity marking and identification number
1 Devices placed on the market in Switzerland or made available on the Swiss market must bear a conformity marking in accordance with Annex 4. The conformity marking presented in Annex V to EU-IVDR is also a permissible conformity marking. 2 The following must not bear a conformity marking: a. devices exclusively for demonstration and presentation purposes; b. devices for performance studies, subject to the provisions of Article 6a of the Ordinance of 1 July 2020 on Clinical Trials with Medical Devices; c. devices in accordance with Article 9. 3 Where the conformity of a device has to be assessed by a conformity assessment body that is designated in accordance with this Ordinance or recognised in connection with an international agreement (designated body), the identification number of this body must be affixed to the conformity marking.
Para. 1 — See the footnote to Art. 4 para. 1 let. e. Para. 2 let. b — SR 810.306
Art. 13 Affixing of conformity markings and identification numbers
1 The conformity marking and, where necessary, the associated identification number shall be affixed to the device itself or its sterile packaging. 2 Where this is not possible or practicable owing to the nature of the device, the conformity marking and, where necessary, the associated identification number must be displayed on the packaging. 3 The conformity marking shall also appear on the instructions for use and on the sales packaging. 4 The requirements of Article 18 paragraphs 3–6 EU-IVDR and the general principles stated in Article 30 of Regulation (EC) No. 765/2008 must also be observed when affixing the conformity marking.
Para. 4 — See the footnote to Art. 4 para. 1 let. e. Para. 4 — Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 of the Council, version according to OJ L 218 of 13.8.2008, p. 30.
Section 2 Classification, Product Information and
Art. 14 Classification
Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks. This classification must comply with the provisions of Annex VIII to EU-IVDR.
See the footnote to Art. 4 para. 1 let. e.
Art. 15 Product information
1 Product information comprises the labelling and instructions for use. It is governed by Chapter III of Annex I to EU-IVDR. 2 It must be written in all three official languages of Switzerland. Symbols established by means of technical standards may be used to replace written statements. 3 The product information may be provided in fewer than the three official languages of Switzerland or in English, provided that: a. the device is supplied exclusively to healthcare professionals or concerns a device in accordance with Article 9; b. it is certain that the user meets the necessary professional and linguistic requirements and qualifications, and is in agreement; c. the protection of patients, users and third parties is ensured; and d. the efficacy and performance of the medical device are not placed at risk. 4 If requested, additional information must be provided to users in one of the official languages of Switzerland. 5 If a product cannot be, or cannot yet be, placed on the market as
Para. 1 — See the footnote to Art. 4 para. 1 let. e. Para. 9 — Inserted by No I of the O of 20 Nov. 2024 (Amendment to the Transitional Regulations and Provision of Details on the Authorised Representative), in force since 1 Jan. 2025 (AS 2024 741).
Art. 16 Unique device identification
1 The manufacturer shall assign to the device and all superordinate packaging layers a unique device identifier (UDI) prior to placing it on the market. 2 The manufacturer must state the UDI on the labelling of the device and all higher levels of packaging. Shipping containers are not considered as a higher level of packaging. . 3 The manufacturer shall maintain a list of all the UDIs he has assigned. This list is part of the technical documentation specified in Annex II to EU-IVDR. It must be kept up-to-date at all times. 4 The obligations and modalities associated with device identification and registration are governed by Articles 24 and 26 and Annex VI to EU--IVDR, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts. 5 Information on the UDI must be registered with Swissmedic in accordance with the EU-IVDR provisions mentioned in paragraph 4.
Para. 1 — Stands for «unique device identifier». Para. 3 — See the footnote to Art. 4 para. 1 let. e. Para. 4 — See Annex 3. Para. 5 — Amended by No I of the O of 20 Nov. 2024 (Device Registration Obligation), in force since 1 July 2026 (AS 2024 742).
