As of June 3, 2024, the ‘Guidance document Incident Economic Operators’ is valid in Switzerland. This is a document that in eleven points describes and clarifies the requirements to be met in the event of an incident, specifying the obligations for Economic Operators: Manufacturers, Distributors, Importers and Authorised Representatives.
The document first clarifies the difference between incident and serious incident, the first aspect to be clarified to operate in full compliance.
An incident is an occurrence resulting from any malfunction or deterioration in the characteristics or performance of a device made available on the market, including errors in use due to ergonomic characteristics, as well as any inadequacy in the information provided by the manufacturer. According to the Swiss MedDO Medical Device Ordinance, the term incident also covers any undesirable side effect and for the In Vitro Diagnostic Devices Regulation IvDO also covers any damage resulting from a medical decision or action not taken based on the information or results provided by the device.
A serious incident is an incident that has caused, may have caused or is likely to cause, directly or indirectly, the death of a patient, user or other person; the temporary or permanent serious deterioration of the state of health of a patient, user or other person; a serious threat to public health. Serious incidents occurring in Switzerland must be reported to Swissmedic, which systematically collects and examines each report.
The document clarifies the roles and responsibilities of the Economic Operators involved following an incident: Manufacturers, Importers, and Distributors have specific obligations, as does the role of the Local Authorised Representative. For example, if the manufacturer is not based in Switzerland or Liechtenstein, his Authorised Representative is responsible for reporting; the Authorised Representative is also obliged to immediately inform the manufacturer of any complaint or report concerning a device for which he has been appointed as Authorised Representative.
The guideline defines in detail how the serious incident report is to be transmitted electronically. It is essential to be aware of the very tight timeframe: if the serious incident clearly constitutes, or has the potential to constitute, a serious and imminent threat to the life or health of a large number of persons, the report must be submitted immediately, and no later than two calendar days after it has become known.
If the serious incident has resulted in the death or unforeseen serious deterioration of a person’s state of health, the report must be submitted without delay and no later than 10 calendar days. All other serious incidents must be reported without delay and no later than 15 calendar days after becoming aware of the incident.
The applicable provisions must be summarised and presented in easily understandable language and in a form that can be used directly in practice.
The reporting system is designed to protect the health of patients and users. In particular, it aims to prevent the recurrence of accidents based on problems in the design, manufacture or use of devices.
Much more information can be found in the complete guidance.
Swissdamed Registration Form
Relevant for those who market Medical Devices in Switzerland is the CHRN application form which, as of August 2024, will be available for the registration of Economic Operators. With this form, Economic Operators will be registered exclusively via the Swiss database on Medical Devices (SWISSDAMED), the database which, like Eudamed, aims to create more transparency, in particular by improving access to information for the public and health professionals.
It is recalled that the CHRN is a unique Swiss registration number that Swissmedic assigns on request, once only, to interested Economic Operators.
Applications for registration and amendment of the CHRN, as well as notifications for mandates, will continue to be accepted in PDF format until July 26, 2024 (submission date). After this date, these forms will no longer be considered.
>> Are you a manufacturer based outside Switzerland and want to market your devices in Switzerland? Thema can be your Swiss Authorised Representative (CH REP), guaranteeing compliance with all obligations and accompanying you successfully to market.
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