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 Post-Market Surveillance
Art. 56 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 83 paragraph 3 EU-MDR.
Para. 3 — See the footnote to Art. 4 para. 1 let. f.
Art. 57 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 66.
Art. 58 Plan
The post-market surveillance plan must satisfy the requirements of Section 1 of Annex III to EU-MDR. Except for custom-made devices, the plan shall be part of the technical documentation referred to in Annex II to EU-MDR.
See the footnote to Art. 4 para. 1 let. f.
Art. 59 Report
1 Manufacturers of class I 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 specified in Article 58; b. a description of any preventive and corrective actions taken, including their rationale. 3 The report forms part of the post-market surveillance technical documentation specified in Annex III to EU-MDR. 4 The manufacturer must update the report when necessary and make it available to the competent authority upon request.
Para. 3 — See the footnote to Art. 4 para. 1 let. f.
Section 2 Safety Report
Art. 60 Obligation
1 Manufacturers of class IIa, class IIb and class III devices shall prepare a safety report for each device and where relevant for each category or group of products. 2 Manufacturers of class IIa devices shall update the safety report when necessary and at least every two years. Manufacturers of class IIb and class III devices must update this report at least annually.
Art. 61 Content
1 The safety report must contain: a. a summary of the results and conclusions of the analyses of the data gathered as a result of the post-market surveillance plan as specified in Article 58; b. 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 clinical 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-MDR. For custom-made devices, the report forms part of the documentation specified in Section 2 of Annex XIII to EU-MDR.
Para. 3 — See the footnote to Art. 4 para. 1 let. f.
Art. 62 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 III devices or implantable 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.
Art. 62 — Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
Section 3 Summary of Safety and Clinical Performan
Art. 63
1 For class III devices and for implantable devices, other than custom-made or investigational devices, the manufacturer must draw up a summary of safety and clinical performance. 2 The summary of safety and clinical performance 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 32, Paragraph 32 EU-MDR. 4 The draft summary must be submitted, together with the documentation, 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. 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). Para. 5 — Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
Section 4 Traceability and Recording of Device Ide
Art. 64 Traceability
1 Distributors and importers shall cooperate with manufacturers or their authorised representatives to achieve an appropriate level of traceability of devices. 2 The duty of disclosure under Article 47c TPA continues for at least 10 years, or for at least 15 years for implantable devices, from the date on which the device was acquired or delivered.
Art. 64 — 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).
Art. 65 Recording the UDI
1 Economic operators and the healthcare institutions shall record and store, preferably by electronic means, the UDI of the class III implantable devices which they have supplied or with which they have been supplied. 2 Swissmedic may extend this obligation to other devices, or categories or groups of devices.
Para. 1 — 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).
Section 5 Vigilance
Art. 66 Reporting obligation
1 Manufacturers of devices made available in Switzerland or natural or legal persons who assemble systems or procedure packs in accordance with Article 22 paragraphs 1 and 3 EU-MDR 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 Articles 27 paragraph 5 and 87–89 EU-MDR. 2bis Where an authorised representative is required pursuant to Article 51, this representative is responsible for the reporting obligation in paragraph 1. Furthermore, the authorised representative must 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 ac
Para. 1 — See the footnote to Art. 4 para. 1 let. f. Para. 1 let. b — Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). Para. 2bis — Inserted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). Para. 3 — Repealed by No I of the O of 19 May 2021, with effect from 26 May 2021 (AS 2021 281).
Art. 67 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 66 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.
