The new article describes in detail certain specific aspects related to the incident reporting requirements introduced in Switzerland.
Table of content
Swissmedic, a Swiss regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for incident reporting by economic actors. The document provides an overview of the relevant requirements set forth under the existing legal framework, as well as additional clarifications and recommendations to be taken into consideration by the parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
In particular, the document describes in detail the specific approach to be followed by the parties involved when reporting incidents associated with medical devices.
Reporting Serious Incidents to Swissmedic
According to the guidance, manufacturers must use the MIR (Manufacturer’s Incident Report) form, available on the Swissmedic website, to report serious incidents. Reports must be submitted electronically in a machine-readable format. They can be completed in any official Swiss language or in English, with any and all mandatory fields filled out.
The completed form should be submitted via email. Additional guidelines for completing the form are provided in the respective document issued by the authority.
In addition to the above, the authority mentions that manufacturers or system assemblers outside Switzerland and Liechtenstein, or their authorized representatives, must select “Other, please specify” in section 1.3.1 of the MIR form and enter “CH Rep” along with the contact details of the authorized representative in section 1.3.4. An economic operator in Liechtenstein can also act as a CH Rep.
Reporting Timelines
The document also outlines the applicable reporting timelines to be followed by the manufacturers responsible for the medical devices in question:
- Immediate Reporting (within 2 days): If the incident poses a serious threat to public health.
- Within 10 Days: If the incident has resulted in an unforeseeable serious deterioration in health.
- Within 15 Days: For all other serious incidents.
If sufficient information is not available within these periods, an initial report must still be submitted. The manufacturer or system assembler is considered informed when the incident first enters their legal sphere, such as when an employee becomes aware of it.
Forms of Submission, Specific Aspects
The document also describes in detail various forms of submissions associated with medical devices. In particular, the ones applicable under the MIR Reporting Process include:
- Initial Report: Must include all available information on the event, affected product, and patient consequences, as well as planned immediate measures, investigation details, and a timeline for reporting.
- Interim Report: Required if original measures change or the final report date is postponed. It should contain all investigation results to date.
- Final Report: Must include all information not available at the time of the initial report, including investigation results, conclusions, corrective measures, and their implementation timeline.
- Combined Initial and Final Report: This can be submitted if all required information for a final report is available within the reporting deadline for a serious incident.
In accordance with the applicable regulatory requirements, medical device manufacturers or system assemblers are responsible for investigating the serious incident and analyzing the affected product, making reasonable efforts to access the product.
In its turn, Swissmedic collects, assesses, and decides on the necessity of additional measures based on initial and final reports. The risk and need for immediate measures are evaluated for initial reports, while final reports are assessed for investigation results, trend data, and conclusions.
Manufacturers or system assemblers should also report a statistically significant increase in the frequency or severity of non-serious incidents, expected side effects, or erroneous results. The trend form, available on the Swissmedic website, must be used for these reports.
Similar serious incidents can be reported collectively as PSRs if the cause is known, the incidents are part of an FSCA, or they occur frequently and are well documented. The PSR form is available on the Swissmedic website.
For CE-marked products used in clinical trials or performance studies, serious incidents are reported as described. Separate guidelines are available for reporting obligations in ongoing trials or studies with non-CE-marked products.
Obligations for User Reports
According to the guidance, specialists must report to Swissmedic using the provided form. Patients can also report incidents directly to Swissmedic.
Swissmedic forwards user reports to the relevant economic operators, who must handle them like any other incident report. The authority additionally emphasizes that the mere receipt of a report from Swissmedic does not absolve the operator from their own reporting obligations.
Furthermore, the appropriate justification must be provided for incidents deemed non-reportable, including explanations as to why the criteria for serious incidents are not met. This includes ruling out malfunctions, deterioration, and causal connections to the manufacturer’s product.
If a user report form is available, a comprehensive justification must also be provided.
Data Protection
Under the applicable laws, Swissmedic is obliged to maintain the confidentiality of data collected under the Therapeutic Products Act, with data processing and disclosure governed by the Act’s provisions on confidentiality and data processing.
Conclusion
In summary, the present guidance provides additional clarifications regarding the regulatory requirements to be followed by the parties involved in operations with medical devices in case of any incidents. The document outlines the scope of information to be included in such reports and also provides the applicable timeframes the manufacturers should comply with.
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