Swiss Economic Operator Vigilance Requirements Under IvDO

With the establishment of Ordinance on In Vitro Diagnostic Medical Devices (IvDO), Switzerland established its own vigilance requirements for in-vitro medical devices. While these do refer to vigilance requirements established under the EU In–Vitro Diagnostic Medical Device Regulations 2017/746 (IVDR) applicable to legacy and non-legacy devices placed on the EU market, they should be considered within the context of placing devices on the Swiss market. However, we continue to observe manufacturers looking to place their devices on the Swiss market that have not aligned their vigilance procedures with Swiss requirements. In this article, we provide an overview of the vigilance requirements established under the IvDO. 

IvDO Vigilance Requirements: Reporting of Serious Incidents

Serious incident reporting requirements established in the IvDO applicable to manufacturers include: 

Incidents During Post-Market Surveillance

Reporting serious incidents that the manufacturer has become aware of during post-market surveillance activities in connection with a device that has been made available on the Swiss market (Article 50, paragraph 1). An important distinction under this requirement is that this covers serious incidents that have not necessarily occurred in Switzerland but are in connection with a device that has been made available in Switzerland (e.g. serious incidents in another market involving a device lot/batch that has also been made available on the Swiss market). 

Reporting Incidents Occurring in Switzerland

Reporting any serious incident involving a device made available in Switzerland that has occurred in Switzerland, as soon as becoming aware of the incident (Article 59, paragraph 1a).

In contrast to Article 50, paragraph 1 of the IvDO, this requirement is only applicable to serious incidents that have occurred in Switzerland. 

FSCA Requirements for Manufacturers under the IvDO

Swissmedic monitors all field safety corrective actions (FSCAs) for devices marketed in Switzerland or Liechtenstein.

Informing Swissmedic and Notified Body

Informing Swissmedic and Notified Body of any corrective (and/or preventive) action taken as deemed necessary by the manufacturer during post-market surveillance (Article 50, paragraph 1). 

Reporting FSCA to Prevent Serious Incidents

Reporting FSCA taken to prevent or minimize the risk of a serious incident in connection with a device that has been made available on the Swiss market (Article 50, paragraph 2).

Applicability to Non-Swiss Incidents

In a similar manner to serious incidents, the above Article 50 FSCA reporting requirements are applicable to FSCAs that have not necessarily occurred in Switzerland but are in connection with a device that has been made available in Switzerland (e.g. FSCA in another market involving a device lot/batch that has been made available on the Swiss market). 

FSCA Reporting in Switzerland

Reporting any FSCA undertaken in Switzerland (Article 59, paragraph 1b).

In contrast to Article 50 of the IvDO, this requirement is only applicable to FSCAs that have occurred in Switzerland.  FSCAs are reportable to Swissmedic must be reported utilizing the official FSCA form made available on the regulator’s website.  Further guidance on Swiss device FSCA requirements is available from Swissmedic. 

Swiss IvDO: Reporting Exemptions, Timeframes, and Considerations

The IvDO (under Article 59, paragraph 2) establishes that exemptions from reporting obligations, modalities, periodic summary reports, trend reporting, and analyses of serious incidents and FSCA established under Article 24(5) and Articles 82-84 of the EU IVDR are also applicable in Switzerland. 

In the case of foreign manufacturers, who must assign a Swiss Authorized Representative in accordance by Article 44 of the IvDO, their authorized representative is responsible for: 

Serious Incident and FSCA Reporting

The serious incident and FSCA reporting obligations are pursuant to Article 59, paragraph 1 of the IvDO. Where serious incidents have occurred in Switzerland or Liechtenstein, these are reported utilizing the Manufacturer Incident Report form. Similar serious incidents that meet the following criteria can be grouped together and reported under a single Periodic Summary Report: 

• • • • Known root cause and/or 
      • Serious incidents are already the subject of an FSCA and/or 
      • The serious incidents occur frequently and are well-documented 

Trend Reports

Submission of trend reports to Swissmedic pursuant to Article 59, paragraph 2 of the IvDO on incidents in Switzerland and abroad (without being requested to do so by Swissmedic). 

Periodic Summary Reports

Submission of Periodic Summary Update Reports (prepared in accordance with Article 84(5) of the EU IVDR) to Swissmedic. 

Swiss IvDO Requirements with MedEnvoy

It is important for foreign manufacturers to note that the IvDO requires that the transfer of these reporting obligations from the manufacturer to the Swiss Authorized Representative must be agreed to in writing in the mandate between both parties. Therefore, it is critical that foreign manufacturers must ensure this transfer of responsibility is explicitly called out in the mandate. 

This article provides an overview of Swiss vigilance requirements established in the IvDO. While further Swiss vigilance guidance is available from Swissmedic, should you have any questions regarding these requirements or require a Swiss Authorized Representative or Importer, get in touch. 

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