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.
Section 1 Scope and Exceptions
Art. 1 Scope
1 This Ordinance applies to: a. medical devices and the associated accessories, as defined in Article 3; b. groups of products without an intended medical purpose in accordance with Annex 1. 2 In this Ordinance, the term devices is used to designate the products defined in paragraph 1. 3 This Ordinance also applies to: a. devices which, when placed on the market or put into service, incorporate as an integral part a medicinal product that has an action ancillary to that of the device; b. devices intended to administer a medicinal product; c. devices manufactured: 1. from tissues or cells of animal origin, or their derivatives, which are non-viable or are rendered non-viable, 2. from derivatives of tissues or cells of human origin that are non-viable or are rendered non-viable; d. devices which, when placed on the market or put into service, incorporate as an integral part non-viable tissues or non-viable cells of human origin or their derivatives that have an action ancillary to that o
Art. 2 Exceptions
1 This Ordinance does not apply to: a. human blood, blood products, plasma or blood cells of human origin, or devices which incorporate, when placed on the market or put into service, such blood products, plasma or cells except for devices referred to in Article 1 paragraph 3 letter a; b. vital organs, tissues or cells and transplant products of human origin; c. vital organs, tissues or cells and transplant products of animal origin; d. products other than those referred to in letters a–c that contain or consist of viable biological material or viable organisms, including living micro-organisms, bacteria, fungi or viruses, in order to achieve or support the intended purpose of the product; e. in vitro diagnostic medical devices; these are subject to Articles 105 and 107; f. non-separable combinations of a medicinal product and device intended to administer a medicinal product that are intended solely for use in this combination and are not reusable; g. combinations which, when placed o
Para. 1 let. j — 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). 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).
Section 2 Definitions and References to European L
Art. 3 Medical device and accessories
1 Medical devices are instruments, apparatus, appliances, softwares, implants, reagents, materials or other articles: a. that are intended by their manufacturer to be used for human beings; b. that do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in their function by such means; and c. that serve to fulfil one or more of the following specific medical purposes either alone or in combination: 1. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, 2. diagnosis, monitoring, treatment, alleviation of, or compensation for, injuries or disabilities, 3. investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, 4. providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations. 2 Medical devices also include: a. devices
Para. 3 let. b — 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. 4 Furtherdefinitions
1 In this Ordinance: a. making available on the market means any transfer or cession of a device, other than an investigational device, 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 an investigational device, on the Swiss market; c. putting into service means the stage at which a device, other than an investigational device, 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. reprocessing means a process carried out on a used device in order to allow its safe reuse including cleaning, di
Para. 1 let. f — Amended by No I of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576). Para. 1 let. f — Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, OJ L117 of 5.5. 2017, p. 1; last amended by Regulation (EU) 2023/607, OJ L 80 of 20.3.2023, p. 24. Para. 1 let. n — Inserte
Art. 5 References to European legislation
1 The equivalent terms specified in Annex 2 and as used in EU-MDR and this Ordinance apply. 2 Where this Ordinance makes reference to provisions of EU-MDR that in turn refer to other provisions of EU-MDR or other EU legislative acts, those provisions also apply. The version in the footnote to Article 4 paragraph 1 letter f is authoritative for references to EU-MDR, while the versions of the relevant EU act set out in Annex 3 number 1 apply to references to other EU acts. This provision excludes onward references to the EU acts listed in Annex 3 number 2; here the Swiss provisions listed in the Annex apply.
Para. 1 — See the footnote to Art. 4 para. 1 let. f.
