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 Scope and Exceptions
Art. 1 Scope
1 This Ordinance applies to in vitro diagnostic medical devices and accessories as defined in Article 3 (Devices). 2 For devices which, when placed on the market or put into service, incorporate as an integral part a medical device in accordance with Article 3 paragraphs 1 and 2 of the Medical Devices Ordinance of 1 July 2020 (MedDO), this Ordinance applies only to the in vitro diagnostic medical device part.
Para. 2 — SR 812.213
Art. 2 Exceptions
This Ordinance does not apply to: a. products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; b. invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen; c. internationally certified reference materials; d. materials used for external quality assessment schemes; e. devices intended exclusively for veterinary diagnostic purposes.
Section 2 Definitions and References to European L
Art. 3 In vitro diagnostic medical device and its accessories
1 An in vitro diagnostic medical device means any medical device in accordance with Article 3 paragraphs 1 and 2 MedDO which: a. is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body; and b. solely or principally for the purpose of providing information on one or more of the following: 1. concerning physiological or pathological processes or states, 2. concerning congenital physical or mental impairments, 3. concerning the predisposition to a particular medical condition or a particular disease, 4. to determine the safety and compatibility with potential recipients, 5. to predict treatment response or reactions, 6. to define or monitor therapeutic measures. 2 Specimen receptacles shall also be deemed to be in vitro diagnostic me
Para. 1 — SR 812.213
Art. 4 Furtherdefinitions
1 In this Ordinance: a. making available on the market means any transfer or cession of a device, other than a device for performance study, for distribution, consumption or use on the Swiss market in the course of a commercial activity, whether in return for payment or free of charge; b. placing on the market means the first making available of a device, other than a device for performance study, on the Swiss market; c. putting into service means the stage at which a device, other than a device for performance study, has been made available to the final user as being ready for use on the Swiss market for the first time for its intended purpose; d. maintenance means measures such as preventive maintenance, software updates, inspection, repair, preparation for first use and reprocessing for reuse or measures to keep a device in functional condition or restore it to functional condition; e. manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has
Para. 1 let. e — Amended 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). Para. 1 let. e — 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 2010/227/EU, OJ L 117 of 5.5.2017, p. 176; last amended by Regulation (EU) 2023/607, OJ L 80 of 2
Art. 5 References to European legislation
1 The equivalent terms specified in Annex 1 and as used in EU-IVDR and this Ordinance shall apply. 2 Where this Ordinance makes reference to provisions of EU-IVDR which, in turn, refer to other provisions of EU-IVDR or other EU legislative acts, those provisions shall also apply. The version in the footnote to Article 4 paragraph 1 letter e is authoritative for references to EU-IVDR, while the versions of the relevant EU acts set out in Annex 2 point 1 apply to references to other EU acts. This provision excludes onward references to the EU acts listed in Annex 2 number 2; here the Swiss provisions listed in the Annex shall apply.
Para. 1 — See the footnote to Art. 4 para. 1 let. e.
