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 Designation
Art. 26 Requirements and application
1 Swissmedic shall only designate conformity assessment bodies which are domiciled in Switzerland, have completed an assessment procedure in accordance with Article 27 and which comply with the requirements set out in Annex VII to EU-IVDR. 2 Applications for designation must be submitted to Swissmedic. They must in particular include: a. details of the activities and the types of devices for which designation is sought; b. proof that the requirements of Annex VII to EU-IVDR are met. 3 Swissmedic shall, within thirty days, check that the application for designation is complete, and shall request the applicant to provide any missing information. 4 It shall review the application and accompanying documents and draw up a preliminary assessment report.
Para. 1 — See the footnote to Art. 4 para. 1 let. e.
Art. 27 Assessment
1 Swissmedic shall conduct an on-site assessment of the conformity assessment body and, if relevant, of all sub-contractors and subsidiaries. 2 If Swissmedic identifies non-compliances in the course of its assessment, it shall draw up a list of non-compliances for the applicant. Swissmedic shall set a deadline for the conformity assessment body by which the latter shall submit to Swissmedic a corrective action plan to address the non-compliances and a preventive action plan. 3 The plans shall indicate the root cause of the identified non-compliances and shall include a timeframe for implementation of the actions therein. 4 Swissmedic shall decide whether the proposed action is suitable and whether the timeframe for implementation is appropriate.
Art. 28 Assessment report
1 If Swissmedic approves the plans required under Article 27 paragraph 2, it shall prepare an assessment report. 2 This shall comprise the following: a. the result of the assessment; b. confirmation that suitable corrective and preventive actions have been appropriately addressed and, where necessary, implemented; c. the scope of the designation.
Art. 29 Issuance and extension of designation
1 Swissmedic shall issue the designation if the conformity assessment body meets the requirements. 2 The extension of designations is subject to the requirements and procedures laid out in Articles 26–28.
Art. 30 Sub-contractors and subsidiaries
1 Designated bodies that delegate part of the work to sub-contractors or to subsidiaries bear full responsibility for the work carried out on their behalf by sub-contractors or by the subsidiaries. 2 They shall verify that the sub-contractor or the subsidiary meets the applicable requirements of Annex VII to EU-IVDR. 3 They must notify Swissmedic if they delegate work under the terms of paragraph 1. They must be able to demonstrate to Swissmedic that the sub-contractor or the subsidiary is capable of carrying out the tasks assigned to it. 4 Conformity assessment activities may only be delegated if the designated body has informed the legal or natural person that applied for conformity assessment accordingly. 5 The designated bodies shall make publicly available a list of their subsidiaries.
Para. 2 — See the footnote to Art. 4 para. 1 let. e.
Art. 31 Duty of cooperation and notification requirement
1 The designated bodies, including their subsidiaries and sub-contractors, are required to keep available for Swissmedic at all times all data that is necessary for assessment, designation, monitoring and re-assessment, including the documents required to assess the qualifications of sub-contractors or subsidiaries. The data must be kept up-to-date at all times. 2 The designated bodies shall notify Swissmedic within 15 days of any change which may affect their compliance with the requirements of Annex VII to EU-IVDR or their ability to conduct conformity assessments.
Para. 2 — See the footnote to Art. 4 para. 1 let. e.
Art. 32 Tariffs
The designated bodies shall issue lists of the standard fees charged for their activities and make these lists publicly available.
Section 2 Cessation of Conformity Assessment Activ
Art. 33
1 If a designated body ceases to carry out its conformity assessment activities, it shall inform Swissmedic and the manufacturers concerned as soon as possible. In the case of a planned cessation of activities, notice must be given one year before the activities cease. Swissmedic shall revoke the designation at the time of cessation of activities. 2 The certificates remain valid for a maximum of nine months following the cessation of activities, provided another designated body assumes responsibility for the devices covered by those certificates and confirms this in writing. 3 The designated body assuming responsibility in accordance with paragraph 2 shall conduct a full assessment of the devices concerned before the nine-month period expires and before issuing new certificates for those devices.
Section 3 Suspension, Restriction or Revocation of
Art. 34 Principle
1 Designation shall be suspended, restricted or revoked if the designated body: a. no longer or only partly meets the requirements; or b. fails to carry out corrective actions ordered by Swissmedic. 2 Suspensions shall be imposed for a maximum of twelve months. They may be extended by a maximum of a further twelve months. 3 If its designation is suspended, restricted or revoked, the designated body must inform the manufacturers concerned within ten days.
Art. 35 Unduly issued certificates
1 In the event of its designation being restricted, suspended or revoked, the designated body shall suspend or revoke any certificates which were unduly issued. 2 If the designated body fails to fulfil this requirement, Swissmedic shall instruct it to suspend or revoke the certificates and set an appropriate deadline for doing so.
Art. 36 Validity of certificates in the event of suspension or restriction of designation
1 If Swissmedic suspends or restricts the designation of a designated body, the certificates concerned remain valid provided Swissmedic: a. confirms within a month that no safety issue exists in relation to the certificates concerned; and b. outlines a timeline and measures to remedy the suspension or restriction. 2 The certificates also remain valid if Swissmedic: a. confirms that during the suspension or restriction, no certificates relevant to the suspension shall be issued, amended or re-issued; and b. states that the designated body is able to continue to monitor and retain responsibility for existing certificates during the suspension or restriction. 3 The designated body shall inform the manufacturers concerned or the persons or entities placing the devices concerned on the market. 4 Should Swissmedic ascertain that the designated body does not have the capability to support existing certificates issued, these certificates retain their validity if the manufacturer of the device
Art. 37 Validity of certificates in the event of designation being revoked
1 If Swissmedic revokes the designation of a designated body, the certificates affected remain valid for nine months provided: a. Swissmedic or, if the manufacturer is domiciled in a contracting state, the competent authority there confirms that there is no safety issue associated with the devices in question, and b. another designated body confirms in writing that it is assuming immediate responsibility for the certificates for these devices and can complete the assessment of the devices within twelve months of designation being revoked. 2 Swissmedic may, within the limits of its competence, extend the provisional validity of the certificates for further periods of three months, which altogether must not exceed twelve months.
Section 4 Monitoring and Re-assessment of Designat
Art. 38
1 Swissmedic shall monitor the designated bodies and their subsidiaries and sub-contractors and carry out re-assessments. In the course of monitoring and re-assessing designated bodies and reviewing their assessments, Swissmedic shall take account of the requirements and procedures set out in Articles 40 and 41 EU-IVDR. 2 It shall verify whether designated bodies still satisfy the requirements of Article 32 paragraph 1 and Annex VII to EU-IVDR three years after designation, and then every four years, in the course of a full re-assessment. This provision is subject to changes in assessment intervals resulting from delegated acts issued by the European Commission. 3 Swissmedic shall carry out an on-site audit at least once a year to ascertain whether the designated bodies and, where necessary, their subsidiaries and sub-contractors fulfil the requirements and obligations of Annex VII to EU-IVDR. 4 For this purpose, it may at any time: a. carry out on-site assessments with or without adva
Para. 1 — See the footnote to Art. 4 para. 1 let. e. Para. 2 — See Annex 3.
