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 Post-market Surveillance
Art. 49 System
1 For each device, manufacturers must plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer's quality management system. 2 The system must be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions. 3 The modalities of the system, particularly the resulting actions, updates and amendments to technical documentation, are governed by Article 78 paragraph 3 EU-IVDR.
Para. 3 — See the footnote to Art. 4 para. 1 let. e.
Art. 50 Incidents and actions
1 Should it become evident in the course of post-market surveillance that preventive and/or corrective actions are necessary, the manufacturer shall implement the appropriate measures and inform the competent authorities and, if applicable, the designated body. 2 If a manufacturer becomes aware of a serious incident in connection with a device that has been made available on the market, or takes action to prevent or minimise the risk of such an incident for medical or technical reasons (field safety corrective actions), it must report the fact in accordance with Article 59.
Art. 51 Plan
The post-market surveillance plan must satisfy the requirements of Section 1 of Annex III to EU-IVDR. The plan shall be part of the technical documentation referred to in Annex II to EU-IVDR.
See the footnote to Art. 4 para. 1 let. e.
Art. 52 Report
1 Manufacturers of class A and B devices must draw up a post-market surveillance report. 2 This report must contain: a. a summary of the results and conclusions of the analyses of the data gathered as a result of the plan in accordance with Article 51; b. a description of any preventive and corrective actions taken, including their rationale. 3 The report is part of the post-market surveillance technical documentation specified in Annex III to EU-IVDR. 4 The manufacturer must update the report when necessary and make it available to the designated body and the competent authority upon request.
Para. 3 — See the footnote to Art. 4 para. 1 let. e.
Section 2 Safety Report
Art. 53 Obligation
1 Manufacturers of class C and D devices shall prepare a safety report for each device and, where relevant, for each category or group of devices. 2 Manufacturers of class C and D devices shall update the safety report when necessary, but at least annually.
Art. 54 Content
1 The safety report must contain: a summary of the results and conclusions of the analyses of the data gathered as a result of the plan in accordance with Article 51; a description of any preventive and corrective actions taken and their rationale. 2 Throughout the lifetime of the device concerned, the safety report must set out: a. the conclusions of the benefit-risk determination; b. the main findings of the post-market performance follow-up; c. the total sales volume of the device; d. an estimate of the size of the population using the device; e. characteristics of the population in letter d; f. the frequency of device usage, where practicable. 3 The safety report forms part of the technical documentation specified in Annexes II and III to EU-IVDR.
Para. 3 — See the footnote to Art. 4 para. 1 let. e.
Art. 55 Review
1 Manufacturers shall make their safety reports available to the designated body involved in the conformity assessment. 2 The designated body shall review the safety report for class D devices and record the outcome of its review with details of any action taken. 3 Manufacturers or their authorised representatives shall, upon request, make the safety report and the outcome of the designated body’s review, with details of any action taken, available to the competent authority.
Section 3 Summary of Safety and Performance
Art. 56
1 For class C and D devices, other than devices for performance studies, the manufacturer must draw up a summary of safety and performance. 2 This summary shall be written in a way that is clear to the intended user and, if relevant, to the patient. 3 The minimum content of the summary is governed by Article 29 paragraph 2 EU-IVDR. 4 The draft of the summary, together with the documentation, must be submitted to the designated body involved in the conformity assessment for validation by that body. 5 The manufacturer shall publish the summary after it has been validated. 6 The manufacturer must mention on the label or instructions for use where the summary is available.
Para. 3 — See the footnote to Art. 4 para. 1 let. e.
Section 4 Traceability and Recording of Device Ide
Art. 57 Traceability
1 Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices. 2 The duty of disclosure under Article 47c TPA applies for at least 10 years from the date on which the device was acquired or delivered.
Art. 58 Storage of the UDI
Economic operators and healthcare institutions shall store and keep, preferably by electronic means, the UDI of devices which they have supplied or with which they have been supplied. The list of these devices, device categories or device groups is specified in implementing acts of the EU Commission in accordance with Article 24 paragraph 11 letter a EU-IVDR.
See Annex 3. See the footnote to Art. 4 para. 1 let. e.
Section 5 Vigilance
Art. 59 Reporting obligation
1 Manufacturers of devices made available on the market in Switzerland must report to Swissmedic: a. any serious incidents involving the device in question that have occurred in Switzerland as soon as they become aware of them; b. any field safety corrective actions undertaken in Switzerland. 2 Exemptions from this reporting obligation, modalities, periodic summary reports, trend reporting and analyses of serious incidents and field safety corrective actions are governed by Article 24 paragraph 5 and Articles 82–84 EU-IVDR. 3 Where an authorised representative is required pursuant to Article 44, this representative is responsible for the reporting obligation in paragraph 1. Furthermore, the authorised representative shall submit the trend reports pursuant to paragraph 2 on incidents in Switzerland and abroad to Swissmedic without being requested to do so. Final reports prepared in accordance with Article 84 paragraph 5 EU-IVDR should be submitted to Swissmedic. The transfer of these ob
Para. 2 — See the footnote to Art. 4 para. 1 let. e.
Art. 60 Reporting systems in hospitals
1 Hospitals must set up an internal reporting system within the framework of an established quality management system for the purpose of reporting under Article 59 paragraph 4. 2 They must designate a suitable competent person (vigilance contact person) with a medical or technical qualification to assume responsibility for reporting to Swissmedic. They must supply this person’s contact details to Swissmedic. 3 Records and all documents created under the vigilance quality management system must be retained for at least 15 years.
