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 Manufacturers
Art. 46 Affixing the conformity marking and clinical evaluation
1 Manufacturers guarantee that their devices have been designed and manufactured in accordance with the requirements of this Ordinance when they place them on the market or put them into service. 2 They must affix the conformity marking to their devices. 3 They must conduct a clinical evaluation in accordance with Article 61 EU-MDR taking account of the amendments to this Article adopted by the European Commission by means of delegated acts and in accordance with Annex XIV to EU-MDR. They must update this clinical evaluation in line with the results of post-market clinical follow-up.
Para. 3 — See the footnote to Art. 4 para. 1 let. f. Para. 3 — See Annex 4.
Art. 47 Technical documentation
1 Manufacturers must list in the technical documentation the information required in Annexes II and III to EU-MDR, 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 of this documentation when requested to do so by the competent authority.
Para. 1 — See the footnote to Art. 4 para. 1 let. f. Para. 1 — See Annex 4.
Art. 48 Document retention requirements
1 Manufacturers must ensure that the following 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: a. complete technical documentation; b. declaration of conformity; c. a copy of the certificates issued, including any amendments and supplements. 2 The document retention period for implantable devices shall be at least 15 years from the date the last device was placed on the market.
Art. 49 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 medical devices. 2 Proof that the person responsible for regulatory compliance possesses the requisite expertise, the responsibilities of this person, exceptions and further modalities are governed by Article 15 EU-MDR. 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. f.
Art. 50 Further obligations
The further obligations incumbent on manufacturers, particularly the requirements to be fulfilled by their quality and risk management systems, are governed by Article 10 EU-MDR.
See the footnote to Art. 4 para. 1 let. f.
Section 2 Authorised Representative
Art. 51 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-MDR. 3bis 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. 4 Changes in authorised representative are governed by Article 12 EU-MDR. 5 Paragraphs 1–4 also apply mutatis mutandis to natural or legal persons who assemble sy
Para. 3 — See the footnote to Art. 4 para. 1 let. f. Para. 3bis — Inserted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). Para. 5 — Inserted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
Art. 52 Person responsible for regulatory compliance
1 Authorised representatives must ensure that they have permanently and continuously at their disposal at least one person who possesses the requisite expertise as regards the requirements for medical devices under this Ordinance and who is responsible for regulatory compliance. 2 In other respects, Article 49 paragraphs 2–4 shall apply mutatis mutandis.
Section 3 Importers
Art. 53
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 51; d. the device is labelled in accordance with this Ordinance and accompanied by 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 at which 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 ar
Para. 4 — See the footnote to Art. 4 para. 1 let. f.
Section 4 Distributors
Art. 54
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 53 paragraph 2; and 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
Para. 4 — See the footnote to Art. 4 para. 1 let. f.
Section 5 Registration of Economic Operators
Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
Art. 55
1 Manufacturers or their authorised representatives and importers must register the information required by part A Section 1 of Annex VI to EU-MDR with Swissmedic within three months of placing a device on the market for the first time. 2 The economic operator in question must report any changes to the information to Swissmedic within one week. 3 Further obligations and registration modalities are governed by Articles 30 paragraph 3 and 31 EU-MDR. 4 Swissmedic shall verify the information provided by the economic operators and assign them a Swiss single registration number (CHRN). 5 Any natural or legal person placing systems and procedure packs on the market for the first time under Article 11 must register their name and the address at which they can be contacted with Swissmedic within three months of placing the system or procedure pack on the market. Where an authorised representative is required under Article 51 paragraph 5, the name and address of the authorised representative mu
Para. 1 — See the footnote to Art. 4 para. 1 let. f. Para. 4 — 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).
