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. 74 Amendment of Annexes
1 The FDHA may amend Annexes 1, 2 and 4 to this Ordinance in line with international and technical progress. 2 Where amendments may pose technical barriers to trade, it shall make them by mutual agreement with the Federal Department of Economic Affairs, Education and Research.
Art. 75 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 mandatory for the Member States of the EU and as listed in Annex 3.
Art. 76 Harmonisation of enforcement
When implementing this Ordinance, Swissmedic shall respect implementing acts adopted by the European Commission on the basis of EU-IVDR.
See the footnote to Art. 4 para. 1 let. e.
Art. 77 Cooperation with the European Commission and authorities of the contracting states
1 Where provided for by international agreements, Swissmedic, the designated bodies, economic operators and the providers of information society services shall cooperate with the European Commission and the authorities of the contracting states. 2 Swissmedic may appoint experts who are qualified to assess conformity assessment bodies in the field of in vitro diagnostic medical devices. 3 Swissmedic may appoint experts to participate in expert groups of the European Commission and the authorities of the contracting states.
Art. 78 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.
Art. 79 EU reference laboratories in Switzerland
1 Laboratories that wish to be designated an EU reference laboratory by the European Commission according to Article 100 paragraph 1 EU-IVDR may apply to Swissmedic for this designation. 2 They must demonstrate to Swissmedic in particular that they: a. meet the criteria set out in Article 100 paragraph 4 EU-IVDR; b. have arranged appropriate liability insurance cover; and c. are able to assume the tasks under Article 100 paragraph 2 EU-IVDR in accordance with the requirements in each case. 3 If the requirements are met, Swissmedic shall propose to the European Commission that the laboratory be designated an EU reference laboratory.
Para. 1 — See the footnote to Art. 4 para. 1 let. e.
Section 2 Amendment of other Legislation and Trans
Art. 80 Amendment of other legislation
The amendment of other legislation is regulated in Annex 5.
Art. 81 Validity of certificates issued under the old legislation
1 Certificates issued before 25 May 2017 under the old legislation retain their validity until the expiry date stated therein, but no longer than 26 May 2025. 2 Certificates that have been issued since 25 May 2017 under the old legislation, were valid on 26 May 2022 and have not subsequently been revoked shall, following expiry of the period indicated on the certificate, be deemed valid until 31 December 2027. 3 Certificates that have been issued since 25 May 2017 under the old legislation, were valid on 26 May 2022 and expired before 9 July 2024 shall be deemed valid until 31 December 2027 if any of the following conditions is met: a. Before the certificates expired, the manufacturer and a designated body in accordance with Chapter 4 or a notified body in accordance with EU-IVDR domiciled in an EU or EEA state signed a written agreement in accordance with section 4.3 subparagraph 2 of Annex VII EU-IVDR regarding the conformity assessment of devices with expired certificates or devices
Art. 81 — 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. 3 let. a — See footnote to Art. 4 para. 1 let. e.
Art. 82 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 specified dates: a. devices with a certificate valid under Article 81: until 31 December 2027; b. devices that did not require the involvement of a designated body for the conformity assessment procedure under the old legislation, for which a declaration of conformity was issued before 26 May 2022 and which require the involvement of a designated body for the conformity assessment procedure in accordance with this Ordinance: 1. Class D devices: until 31 December 2027, 2. Class C devices: until 31 December 2028, 3. Class B devices: until 31 December 2029, 4. Class A devices placed on the market in a sterile condition: until 31 December 2029. 1bis Devices shall not be placed on the market or brought into service in accordance with paragraph 1 unless the following conditions have been met: a. The devices still conform with the old legislation. b. The devices have not undergone any significant changes in thei
Para. 1 let. b let. 4 — 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. 1bis let. d — See footnote to Art. 4 para. 1 let. e. Para. 1bis let. f let. 3 — 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). Para. 3 — Amended
Art. 83 Requirements for devices manufactured and used in healthcare institutions
The requirements set out in Article 9 for devices manufactured and used in healthcare institutions apply from the following dates: a. the requirements set out in Article 5 paragraph 5 letters b, c and e-i EU-IVDR: from 26 May 2024; b. the requirements set out in Article 5 paragraph 5 letter d EU-IVDR: from 31 December 2030.
let. a — See the footnote to Art. 4 para. 1 let. e let. b — 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).
Art. 84 Exemptions for in vitro diagnostic medical devices
Exemptions issued by Swissmedic under Article 9 paragraph 4 and Article 17 paragraph 3 MedDO in the version dated 1 August 2020 shall retain their validity.
SR 812.213 AS 2001 3487; 2020 2975
Art. 85 Affixing the UDI
The UDI must be affixed in accordance with Article 16 paragraph 2: a. for class D devices: from 26 May 2023; b. for class B and C devices: from 26 May 2025; c. for class A devices: from 26 May 2027;
Art. 86 Designation of an authorised representative
If the manufacturer is domiciled in an EU or EEA state or has designated an authorised representative domiciled in an EU or EEA state, that manufacturer must designate an authorised representative in accordance with Article 44 paragraph 1 for all devices placed on the market as from 26 May 2022 within the following time periods: a. for class D devices: by 31 December 2022; b. for class B and C devices: by 31 March 2023; c. for class A devices: by 31 July 2023.
Art. 87
Repealed by No I of the O of 20 Nov. 2024 (Amendment to the Transitional Regulations and Provision of Details on the Authorised Representative), with effect from 1 Jan. 2025 (AS 2024 741).
Art. 88 Registration of economic operators
Economic operators that have placed devices on the market prior to 26 May 2022 in accordance with Article 22a MedDO in the version dated 26 November 2017 must register the information required under Article 48 paragraph 1 by 26 November 2022.
SR 812.213 AS 2017 5935
Art. 89 Conformity assessment bodies
1 Conformity assessment body designations issued under Section 4 of MedDO in the version dated 26 November 2017 shall become void for in vitro diagnostic medical devices. 2 A conformity assessment body whose designation has become void in accordance with paragraph 1 and that issued the certificates under the old legislation remains 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 4 or a notified body in accordance with EU-IVDR domiciled in an EU or EEA state that this body will carry out the surveillance. 2bis The designated body under Article 82 paragraph 1bis letter f shall be responsible for surveillance of the devices covered by the written agreement from 26 September 2025 at the latest. If the written agreement covers devices intended to replace other devices for which certificates were issued under the under the old legislation,
Para. 1 — SR 812.213 Para. 1 — AS 2001 3487; 2010 1215; 2015 999; 2017 5935 Para. 2 — See footnote to Art. 4 para. 1 let. e. Para. 2 — 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. 2bis — 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.
Art. 90 Notification and registration of devices
1 Until Article 16 paragraph 5 enters into force, the notification obligation for manufacturers domiciled in Switzerland according to Article 6 paragraphs 2 and 4 MedDO in the version dated 26 November 2017 continue to apply. 2 For devices placed on the market on or after 1 July 2026, registration with Swissmedic in accordance with Article 16 paragraph 5 must be completed by 31 December 2026. 2bis For devices under Article 22a of the Medical Devices Ordinance of 17 October 2001 that were placed on the market on or after 26 November 2017, and for devices placed on the market on or after 26 May 2022, registration with Swissmedic in accordance with Article 16 paragraph 5 must be completed without delay if the manufacturer or the authorised representative is required to report a serious incident under Article 59 paragraph 1 letter a, a field safety corrective action under Article 59 paragraph 1 letter b or a trend under Article 59 paragraph 2. 3 The notification obligation according to Art
Art. 90 — Amended by No I of the O of 20 Nov. 2024 (Device Registration Obligation), in force since 1 July 2026 (AS 2024 742). Para. 1 — SR 812.213 Para. 1 — AS 2001 3487; 2017 5935 Para. 2 — Amended by No I of the O of 20 Nov. 2024 (Device Registration Obligation), in force since 1 July 2026 (AS 2024 742). Para. 2bis — AS 2017 5935 Para. 2bis — Inserted by No I of the O of 20 Nov. 2024 (Device Registration Obligation), in force since 1 July 2026 (AS 2024 742).
Art. 91 Entry into force
1 Subject to the exceptions in paragraph 2, this Ordinance enters into force on 26 May 2022. 2 …
Para. 2 — Repealed by No I of the O of 20 Nov. 2024 (Device Registration Obligation), with effect from 1 July 2026 (AS 2024 742).
