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Section 1 Manufacturers
Art. 39 Affixing the conformity marking and performance evaluation
1 Manufacturers guarantee that their devices have been designed and manufactured in accordance with the requirements of this Ordinance when placing them on the market or putting them into service. 2 They must affix the conformity marking to their devices. 3 They must conduct a performance evaluation in accordance with Article 56 and Annex XIII to EU-IVDR. They must update this performance evaluation based on the results of the post-market performance follow-up.
Para. 3 — See the footnote to Art. 4 para. 1 let. e.
Art. 40 Technical documentation
1 Manufacturers must specify in the technical documentation the information required in Annexes II and III to EU-IVDR, taking account of the amendments to these Annexes made by the European Commission by means of delegated acts. 2 Manufacturers must submit either the complete technical documentation or a summary thereof when requested to do so by the competent authority.
Para. 1 — See the footnote to Art. 4 para. 1 let. e. Para. 1 — See Annex 3.
Art. 41 Document retention requirements
Manufacturers must ensure that the following documents are available to the competent authority for at least ten years after the last device covered by the declaration of conformity has been placed on the market: the complete technical documentation; the declaration of conformity; a copy of the certificates issued, including any amendments and supplements.
Art. 42 Person responsible for regulatory compliance
1 Manufacturers must have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices. 2 Proof of the requisite expertise the person responsible for regulatory compliance possesses, the responsibilities of this person, exceptions and further modalities are governed by Article 15 EU-IVDR. 3 The person responsible for regulatory compliance must have a deputy. If a number of persons are jointly responsible for regulatory compliance, their respective areas of responsibility shall be stipulated in writing. 4 The person responsible for regulatory compliance must suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.
Para. 2 — See the footnote to Art. 4 para. 1 let. e.
Art. 43 Further obligations
The further obligations incumbent on manufacturers, particularly the requirements regarding their quality and risk management systems, are governed by Article 10 EU-IVDR.
See the footnote to Art. 4 para. 1 let. e.
Section 2 Authorised Representative
Art. 44 Obligations
1 Where the manufacturer of a device is not domiciled in Switzerland, the device may only be placed on the market if the manufacturer designates an authorised representative domiciled in Switzerland by means of a written mandate. 2 The authorised representative is responsible for the formal and safety-related aspects of placing the device on the market. 3 The authorised representative’s rights and obligations and the scope of its mandate are governed by Article 11 EU-IVDR. 4 The manufacturer and authorised representative may contractually agree that, instead of the authorised representative keeping available a copy of the technical documentation, the manufacturer shall, on request, submit the documentation straight to Swissmedic. The authorised representative must ensure that the documentation is submitted within seven days. 5 Changes in authorised representative are governed by Article 12 EU-IVDR.
Para. 3 — See the footnote to Art. 4 para. 1 let. e.
Art. 45 Person responsible for regulatory compliance
1 Authorised representatives shall have permanently and continuously at their disposal at least one person who possesses the requisite expertise as regards the requirements for in vitro diagnostic medical devices under this Ordinance and who is responsible for regulatory compliance. 2 In other respects, Article 42 paragraphs 2–4 shall apply mutatis mutandis.
Section 3 Importers
Art. 46
1 Importers may only place on the market devices that comply with this Ordinance. Before placing devices on the market, they shall verify that: a. the device bears the conformity marking; b. the declaration of conformity has been drawn up; c. the manufacturer is identified and has designated an authorised representative in accordance with Article 44; d. the device is labelled in accordance with this Ordinance and accompanied by the instructions for use; e. the manufacturer has assigned a UDI where applicable. 2 Importers shall indicate on the device or on its packaging or in a document accompanying the device, their name, place of business and the address where they can be contacted. 3 Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Ordinance, it must not place the device on the market until it has been brought into conformity. 4 The further obligations of importers prior to and after placing a device on the market a
Para. 4 — See the footnote to Art. 4 para. 1 let. e.
Section 4 Distributors
Art. 47
1 When making a device available on the market, distributors must, in the context of their activities, act with due care in relation to the requirements applicable. Before making a device available on the market, distributors must verify that: a. the device bears the conformity marking; b. the declaration of conformity has been drawn up; c. the device is accompanied by the product information; d. where devices have been imported, the importer has provided the information required in Article 46 paragraph 2; e. the manufacturer has assigned a UDI where applicable. 2 With the exception of paragraph 1 letter d, a sampling method may be used for the purposes of verification. 3 Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Ordinance, it must not make the device available on the market until it has been brought into conformity. 4 The further obligations of distributors prior to and after making a device available on the
Para. 4 — See the footnote to Art. 4 para. 1 let. e.
Section 5 Registration of Economic Operators
Art. 48
1 Manufacturers or their authorised representatives and importers must register the information required by Part A, Section 1 of Annex VI to EU-IVDR with Swissmedic before placing a device on the market for the first time. 2 The economic operator in question must report any changes to the information provided to Swissmedic within one week. 3 Further obligations and registration modalities are governed by Article 27 paragraph 3 and Article 28 EU-IVDR. 4 Swissmedic shall verify the information provided by the economic operators and assign them a Swiss single registration number (CHRN).
Para. 1 — See the footnote to Art. 4 para. 1 let. e. Para. 1 — Amended by No I of the O of 20 Nov. 2024 (Device Registration Obligation), in force since 1 July 2026 (AS 2024 742).
