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 Enforcement
Art. 93 Amendment of Annexes
1 The FDHA may amend Annexes 1–3 and 5–6 to this Ordinance in line with international and technical progress. 2 Where amendments may pose technical barriers to trade, it shall effect them by mutual agreement with the Federal Department of Economic Affairs, Education and Research.
Para. 1 — Amended by No I of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576).
Art. 94 Information on directly applicable legal acts of the European Commission
Swissmedic shall provide on its website information on legal acts of the European Commission that, in accordance with this Ordinance, are directly applicable in Switzerland in the version binding upon the Member States of the EU and as listed in Annex 4.
Art. 95 Harmonisation of enforcement
1 When implementing this Ordinance, Swissmedic shall respect the implementing acts adopted by the European Commission on the basis of EU-MDR. 2 Regulations (EU) No 207/2012 and No 722/2012 shall remain in force until such time as they are repealed in the EU by implementing acts adopted by the European Commission on the basis of EU-MDR.
Para. 1 — See the footnote to Art. 4 para. 1 let. f. Para. 2 — Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices, Amended by OJ L 72 of 10.3.2012, p. 28. Para. 2 — Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues
Art. 96 Cooperation with the European Commission and authorities of the contracting states
1 Where provided for by international agreements, Swissmedic, the designated bodies and economic operators as defined in Art. 47 TPA shall cooperate with the European Commission and the authorities of the contracting states. 2 Swissmedic may appoint experts who are qualified to evaluate conformity assessment bodies in the field of medical devices. 3 Swissmedic may appoint experts to participate in expert groups of the European Commission and the authorities of the contracting states.
Para. 1 — 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. 97 Collaboration with the customs authorities
1 The customs authorities provide Swissmedic with information on the import, export and transit of devices. 2 Swissmedic may mandate the customs authorities to detain devices for further inspection and to obtain samples. 3 It may provide the customs authorities with information about ongoing or concluded administrative or criminal proceedings and sanctions in connection with market surveillance.
Para. 3 — 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. 98 Expert laboratories in Switzerland
1 Laboratories that wish to be designated an expert laboratory by the European Commission in accordance with Article 106 paragraph 7 EU-MDR may apply to Swissmedic for designation. 2 They must demonstrate to Swissmedic in particular that they: a. meet the criteria set out in Article 106 paragraph 8 EU-MDR; and b. are able to assume the tasks under Article 106 paragraph 10 EU-MDR, taking account of the amendments to this provision adopted by the European Commission by means of delegated acts, in accordance with the requirements in each case. 3 They must operate in one of the following fields: a. physico-chemical characterisation; b. microbiological, mechanical, electrical, electronic or non-clinical biological and toxicological testing or biocompatibility testing. 4 If the requirements are met, Swissmedic shall propose to the European Commission that the laboratory be designated an expert laboratory.
Para. 1 — See the footnote to Art. 4 para. 1 let. f. Para. 2 let. b — See Annex 4.
Section 2 Repeal of other Legislation and Transiti
Art. 99 Repeal of other legislation
The following ordinances are repealed: 1. the Medical Devices Ordinance of 17 October 2001; 2. the Ordinance of 22 June 2006 on the List of Prescription Medical Devices.
let. 1 — [AS 2001 3487;2004 4037 no I 5, II para. 2; 2008 4377 Annex 5 no 2; 2010 1215, 2749 no I 7; 2015 999; 2017 5935; 2019 999 Art. 28 para. 2; 2020 2975] let. 2 — [AS 2006 3679]
Art. 100 Validity of certificates issued under the old legislation
1 Certificates issued under the old legislation prior to 25 May 2017 shall retain their validity until the expiry date stated therein, but no longer than 26 May 2022. 2 Certificates issued under the old legislation from 25 May 2017 that were valid on 26 May 2021 and that were not revoked thereafter remain valid until the date specified in Article 101 paragraph 1 letter b for the relevant risk class of the devices. 3 Certificates issued under the old legislation from 25 May 2017 that were valid on 26 May 2021 but which expired before 20 March 2023 remain valid until the date specified in Article 101 paragraph 1 letter b for the relevant risk class of the devices, provided any one of the following requirements is met: a. Before expiry of the certificates, the manufacturer and a designated body in accordance with Chapter 5 or a notified body in accordance with the EU-MDR domiciled in an EU or EEA member state, have signed a written agreement in accordance with Annex VII section 4.3 subpar
Para. 2 — Amended by No I of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576). Para. 3 let. a — See footnote to Art. 4 para. 1 let. f. Para. 3 let. c — Inserted by No I of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576).
Art. 101 Placing on the market of devices that comply with the old legislation
1 The following devices may be placed on the market or put into service until the date specified: a. devices for which the conformity assessment procedure under the old legislation did not require the involvement of a designated body, for which a declaration of conformity was issued before 26 May 2021, and for which the conformity assessment procedure under this Ordinance requires the involvement of a designated body: until 31 December 2028; b. devices with a certificate valid under Article 100: 1. class III devices and implantable class IIb devices, with the exception of sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors: until 31 December 2027, 2. class IIb devices that do not fall under number 1, class IIa devices and class I devices that are placed on the market in a sterile condition, or class I devices with a measuring function: until 31 December 2028. 1bis The placing on the market or putting into service of
Art. 101 — Amended by No I of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576). Para. 1bis let. d — See footnote to Art. 4 para. 1 let. f.
Art. 102 Derogations for non-compliant medical devices
Derogations issued by Swissmedic under Article 9 paragraph 4 of the Medical Devices Ordinance of 17 October 2001 shall retain their validity.
See the footnote to Art. 99 no 1.
Art. 103 Devices incorporating devitalised tissues or cells of human origin
1 Devices incorporating devitalised tissues or cells of human origin or their derivatives as specified in Article 1 paragraph 3 letters c no. 2 and d that were lawfully placed on the market or put into service prior to 26 May 2021 may continue to be made available on the market or put into service until 26 May 2025. Art. 101 paragraph 2 applies mutatis mutandis. 2 Until such time as a corresponding special Ordinance is issued, devices covered by Article 2a paragraph 2 TPA are subject to the Medical Devices Ordinance of 17 October 2001. Devices covered by Article 2a paragraph 2 TPA that were lawfully placed on the market prior to 26 May 2021 may continue to be made available on the market or put into service until such time as a corresponding special Ordinance is issued.
Para. 2 — See the footnote to Art. 99 no 1.
Art. 104 Affixing the UDI
The UDI required by Article 17 paragraph 2 must be affixed: a. for implantable and class III devices: from 26 May 2021; b. for class IIa and IIb devices: from 26 May 2023; c. for class I devices: from 26 May 2025; d. for reusable devices where the UDI has to be affixed to the device itself: two years after the dates given in letters a–c for the respective class of devices.
Art. 104a Designation of an authorised representative
1 If the manufacturer is domiciled in an EU or EEA state or if the manufacturer has designated an authorised representative domiciled in an EU or EEA state, that manufacturer must, for all devices placed on the market after 26 May 2021, designate an authorised representative in accordance with Article 51 paragraph 1 within the following time periods: a. for class III devices, class IIb implantable devices and active implantable devices: by 31 December 2021; b. for non-implantable class IIb devices and class IIa devices: by 31 March 2022; c. for class I devices: by 31 July 2022. 2 For systems and procedure packs, an authorised representative in accordance with Article 51 paragraph 5 must be appointed by 31 July 2022.
Art. 104a — Inserted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
Art. 104abis Placing information about the authorised representative
For class I devices and for systems and procedure packs that are placed on the market in accordance with the new legislation, the information specified in Annex 1 Chapter III Section 23.2 letter d EU-MDR about the authorised representative in accordance with Article 51 paragraph 1 or 5 of this Ordinance may be included in a document accompanying the device until 31 July 2023.
Art. 104abis — 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). See the footnote to Art. 4 para. 1 let. f.
Art. 104b
Inserted by No I of the O of 19 May 2021 (AS 2021 281). Repealed by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, with effect from 26 Mai 2022 (AS 2022 291).
Art. 105
Repealed by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, with effect from 26 May 2022 (AS 2022 291).
Art. 106 Groups of products without an intended medical purpose
1 Unless Swissmedic has designated common specifications in accordance with Article 8 paragraph 1 for the groups of products without an intended medical purpose in accordance with Annex 1, these products are subject to the old legislation. 2 Products that fall within the groups of products in Annex 1 and for which the manufacturer is conducting or is intending to conduct a clinical investigation in order to generate clinical data for the clinical evaluation to confirm conformity with the relevant general safety and performance requirements in accordance with Article 6 paragraph 2 and with the common specifications in accordance with Article 8 paragraph 1, and for which the conformity assessment procedure requires the involvement of a designated body in accordance with Chapter 5 or a notified body in accordance with the EU-MDR domiciled in an EU or EEA member state, may be placed on the market or put into service until 31 December 2029 if the following requirements are met: a. The produ
Art. 106 — Amended by No I of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576). Para. 2 — See footnote to Art. 4 para. 1 let. f. Para. 3 let. a — SR 810.306
Art. 107 Conformity assessment bodies
1 Conformity assessment body designations under Section 4 of the Medical Devices Ordinance of 17 October 2001 shall become void. 2 A conformity assessment body whose designation in accordance with paragraph 1 is no longer valid and which issued the certificates under the old legislation shall remain responsible for the appropriate surveillance of all applicable requirements relating to the devices it has certified, unless the manufacturer has agreed with a designated body in accordance with Chapter 5 or a notified body in accordance with the EU-MDRdomiciled in an EU or EEA member state that this body will conduct the surveillance. 2bis The designated body in accordance with Article 101 paragraph 1bis letter f shall become responsible for the surveillance of the devices covered by the written agreement from 26 September 2024 at the latest. If the written agreement covers devices intended to replace devices for which certificates were issued under the old legislation, the surveillance sh
Para. 1 — See the footnote to Art. 99 no 1. Para. 2 — See footnote to Art. 4 para. 1 let. f. Para. 2 — Amended by No I of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576). Para. 2bis — Inserted by No I of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576). Para. 2ter — Inserted by No I of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576). Para. 2quater — Inserted by No I of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576). Para. 4 — Re
Art. 108 Notification of devices, systems and procedure packs
1 Until Article 17 paragraph 5 enters into force, the following notification obligations shall continue to apply to natural or legal persons domiciled in Switzerland: a. for manufacturers and natural or legal persons who assemble systems or procedure packs under Article 22 paragraphs 1 and 3 EU-MDR: the notification obligations set out in Article 6 paragraphs 1 and 4 of the Medical Devices Ordinance of 17 October 2001: b. for natural or legal persons who place medical devices on the market under Article 2 paragraph 1 of the Medical Devices Ordinance of 17 October 2001: the notification obligations set out in Article 6 paragraphs 3 and 4 of the Medical Devices Ordinance of 17 October 2001. 2 ...
Art. 108 — Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). Para. 1 let. a — See the footnote to Art. 4 para. 1 let. f. Para. 1 let. a — See the footnote to Art. 99 no 1. Para. 2 — Comes into force at a later date (Art. 110 para. 2).
Art. 109
Repealed by No I of the O of 19 May 2021, with effect from 26 May 2021 (AS 2021 281).
Art. 110 Commencement
1 Subject to the exceptions in paragraph 2, this Ordinance comes into force on 26 May 2021. 2 Articles 17 paragraph 5 and 108 paragraph 2 come into force at a later date.
Para. 2 — Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
