Swiss Economic Operator Vigilance Requirements Under MedDO

With the establishment of Medical Devices Ordinance (MedDO), Switzerland established its own Swiss MedDO vigilance requirements for medical devices. While these do refer to vigilance requirements established under the EU Medical Device Regulations 2017/745 (MDR) 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 MedDO. 

Swiss MedDO Vigilance Requirements: Reporting of Serious Incidents

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

Incidents During Post-Market Surveillance

Reporting serious incidents that the manufacturer has become aware of in connection with a device that has been made available on the Swiss market (Article 57, 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 66, paragraph 1a). 

In contrast to Article 57, paragraph 1 of the MedDO, this requirement is only applicable to serious incidents that have occurred in Switzerland. 

Field Safety Corrective Actions under the MedDO

Swissmedic monitors all field safety corrective actions (FSCAs) for devices marketed in Switzerland or Liechtenstein. FSCA requirements established in the MedDO applicable to manufacturers include: 

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 57, paragraph 1).  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 57, paragraph 2).

Reporting FSCA to Prevent Serious Incidents

In a similar manner to serious incidents, the Article 57 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). 

Reporting any FSCA undertaken in Switzerland (Article 66, paragraph 1b).

In contrast to Article 57 of the MedDO, this requirement is only applicable to FSCAs that have occurred in Switzerland. FSCAs 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 MedDO: Reporting Exemptions, Timeframes, and Considerations

The MedDO (under Article 66, paragraph 2) establishes that exemptions from reporting obligations, modalities, periodic summary reports, trend reporting, and analyses of serious incidents and FSCA established under Article 27(5) and Articles 87-89 of the EU MDR are also applicable in Switzerland. 

In the case of foreign manufacturers, who must assign a Swiss Authorized Representative in accordance with Article 51 of the MedDO, their authorized representative is responsible for: 

Serious Incident and FSCA Reporting

The serious incident and FSCA reporting obligations under Article 57, paragraph 1 of the MedDO. 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 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 to pursuant Article 57, paragraph 2 of the MedDO on incidents in Switzerland and abroad (without being requested to do so by Swissmedic).

Periodic Summary Reports

Submission of Periodic Summary Update Reports (prepared by Article 89(5) of the EU MDR) to Swissmedic.

Swiss MedDO Requirements with MedEnvoy

It is important for foreign manufacturers to note that the MedDO 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 ensure this transfer of responsibility is explicitly called out in the mandate.

This article provides an overview of Swiss MedDO Vigilance requirements. While further Swiss MedDO 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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