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 Conformity assessment
Art. 17 Principle
1 Any natural or legal person who is domiciled in Switzerland and makes devices available on the market in Switzerland or in a contracting state must, upon request, provide the authorities which are responsible for controls in the field of market surveillance, with the declaration of conformity. [tab] 2 A manufacturer domiciled in Switzerland and who places a device on the market in Switzerland or in a contracting state must, prior to placing it on the market, carry out an assessment of the device’s conformity in accordance with the applicable conformity assessment procedures. The manufacturer and the importer must be able to prove that such a conformity assessment has been carried out and that the device is compliant. [tab] 3 A manufacturer who puts into service in Switzerland or in a contracting state a device that is not placed on the market, with the exception of devices in accordance with Article 9, and who is domiciled in Switzerland must carry out an assessment of the device’s c
Para. 4 — See the footnote to Art. 4 para. 1 let. e.
Art. 18 Exemptions
1 On a duly justified request, Swissmedic may authorise the placing on the market and putting into service of a specific device the use of which is in the interest of public health, patient safety or health even though: a. the relevant conformity assessment procedure in accordance with Article 19 has not been carried out; or b. the language requirements in Article 15 paragraph 2 have not been met. 2 Individual devices, apart from devices for self-testing, that have not undergone the relevant conformity assessment procedure may be placed on the market and used without authorisation from Swissmedic provided: a. they are used to test samples with the aim of averting or treating life-threatening conditions or permanent impairments of a body function; b. no conforming device is available for this specific intended purpose; c. they are used exclusively in the laboratory to investigate samples from an individual person; d. the treating healthcare professional has informed the individual perso
Art. 19 Procedure
The conformity assessment procedure is governed by Article 48 and by Annexes IX–XI to EU-IVDR.
See the footnote to Art. 4 para. 1 let. e.
Art. 20 Involvement of a designated body
1 When a designated body is involved, all the information necessary for the conformity assessment must be made available to it. 2 Manufacturers must not simultaneously apply to more than one designated body in Switzerland or a contracting state to carry out a conformity assessment procedure for the same device. 3 Any natural or legal person who applies to a designated body must declare whether an application to a different designated body in Switzerland or a contracting state has been withdrawn before a decision was issued or rejected by a different designated body in Switzerland or a contracting state. 4 If a manufacturer withdraws its application to have a conformity assessment procedure carried out before the designated body has issued its decision on the assessment, the designated body in question shall notify Swissmedic and the other designated bodies. 5 Where a manufacturer voluntarily changes the designated body, it must comply with the requirements of Article 53 EU-IVDR.
Para. 5 — See the footnote to Art. 4 para. 1 let. e.
Section 2 Certificate of Conformity
Art. 21 Issuing and content
1 The designated bodies issue certificates of conformity in accordance with Annexes IX–XI to EU-IVDR (Certificates). 2 The certificates must be issued in one of the three official languages of Switzerland or in English. 3 They must, as a minimum, include the information required in Annex XII to EU-IVDR, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts. 4 Certificates issued by bodies designated under EU law and domiciled in a state of the EU or European Economic Area (EEA) but not recognised by an international agreement are deemed equivalent to certificates issued by Swiss bodies if it can be credibly demonstrated that: a. the conformity assessment procedures applied meet Swiss requirements; and b. the certificates were issued by a body with an equivalent qualification to that required in Switzerland.
Para. 1 — See the footnote to Art. 4 para. 1 let. e. Para. 3 — See Annex 3.
Art. 22 Validity
1 Certificates are valid for a maximum of five years. The expiry date must be indicated on the certificate. 2 At the manufacturer's request, the validity of the certificate may be extended by a maximum of five years following a re- assessment carried out in accordance with the applicable conformity assessment procedure. Certificates may be extended more than once. 3 Any supplement to a certificate is valid for the same period as the certificate to which it belongs.
Art. 23 Suspension, restriction and revocation
1 If a designated body finds that a manufacturer no longer fulfils the requirements of this Ordinance, it shall impose on that manufacturer a suitable deadline for restoring compliance. 2 If this deadline passes without the manufacturer taking suitable corrective action, the designated body shall suspend, revoke or restrict the certificate in question. 3 A certificate that has been amended, suspended or revoked by a designated body must no longer be used in its original form.
Art. 24 Documentation requirements
1 The designated body shall provide Swissmedic and the other designated bodies with: a. all information on certificates it has issued and any amendments or supplements to such certificates; b. information on suspended, reinstated or revoked certificates; c. information on certificates it has refused; d. information on restrictions imposed on certificates. 2 Notifications of certificates for Class D devices, with the exception of applications to supplement or renew existing certificates, must include the documents specified in Article 50 paragraph 1 EU-IVDR.
Para. 2 — See the footnote to Art. 4 para. 1 let. e.
Section 3 Declaration of Conformity
Art. 25
1 If the applicable conformity assessment procedure has demonstrated that the requirements of this Ordinance have been fulfilled, the manufacturer of devices, apart from devices used for performance studies, issues a declaration of conformity. The manufacturer shall continuously update this declaration. 2 The declaration of conformity shall include the information required in Annex IV to EU-IVDR, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts. It must be written in one of the three official languages of Switzerland or English or translated into one of these languages. 3 If a device also requires a manufacturer's declaration of conformity for aspects not covered by this Ordinance but nevertheless required by other legislation in order to demonstrate compliance with that legislation, a single declaration of conformity shall be drawn up. 4 By drawing up the declaration of conformity, the manufacturer assumes responsibility for
Para. 2 — See the footnote to Art. 4 para. 1 let. e. Para. 2 — See Annex 3.
