Economic operators

The manufacturer or SPPP of a device made available in Switzerland or Liechtenstein must report any serious incidents that have occurred in Switzerland or Liechtenstein to Swissmedic (materiovigilance@swissmedic.ch). For manufacturers or SPPPs who are not based in Switzerland or Liechtenstein, the authorised representative assumes responsibility for this task. In this case, the report can be submitted by the manufacturer, the SPPP or their authorised representative. Importers and distributors are required to immediately report suspected incidents to the manufacturer or the SPPP or their authorised representative. Distributors must also report suspected incidents to the importer. Further information can be found via the following link: 

For incidents that are classed as serious and that have occurred in Switzerland or Liechtenstein, you must complete the following form (Manufacturer Incident Report (MIR)) in English or one of the Swiss national languages. Then, press the "submit XML by E-Mail" button at the end of the form and send the generated XML file and the PDF file to materiovigilance@swissmedic.ch: 

If you, as an authorised representative, or as a manufacturer or SPPP based outside Switzerland or Liechtenstein, report serious incidents, you must select the "Other, please specify" option in section 1.3.1 of the MIR form "Submitter of the report" and enter "CH Rep" in the adjacent text field. The contact details of the authorised representative should be entered in section 1.3.4 "Submitter's details". In addition, the contact details of the authorised representative must be entered in section 1.3.4 “Submitter's details”. The mailing list for submissions to Swissmedic must include the authorised representative using the contact details provided in section 1.3.4d.

The help text provides detailed explanations for each section of the form and the codes you will need to complete it:

The European Commission has created a document containing answers to frequently asked questions regarding the use of the reporting form for serious incidents and IMDRF codes.

Regarding the use of IMDRF codes by economic operators for serious incidents and FSCAs, the video «N43 Adverse Event Terminology Codes - Pilot Training» prepared by IMDRF can be consulted as well:

IMDRF Trainings | International Medical Device Regulators Forum

Disclaimer: The exact criteria for reporting serious incidents and FSCAs are defined by Swissmedic and are not the subject of this training. Please refer to the further information on the Swissmedic website.

If a manufacturer or SPPP notices a statistically significant increase in the frequency or severity of:

• non-serious incidents
• expected undesirable side-effects
• a significant increase in expected erroneous results established in comparison to the stated performance of the device,

the manufacturer or the SPPP must report this to Swissmedic (materiovigilance@swissmedic.ch) using the form below. For manufacturers or SPPPs who are not based in Switzerland or Liechtenstein, the authorised representative assumes responsibility for this task. In this case, the report can be submitted by the manufacturer, the SPPP or their authorised representative. If the manufacturer or SPPP submits reports directly to Swissmedic, the authorised representative must be included in the mailing list using the contact details provided in section 1.3.4f of the form.

Similar serious incidents that meet the following criteria can be grouped together and reported as Periodic Summary Reports (PSRs):

• The root cause is known and/or
• The serious incidents are already the subject of an FSCA and/or
• The serious incidents occur frequently and are well documented.

To initiate a Periodic Summary Report, complete the following form in English or one of the Swiss national languages and send it to materiovigilance@swissmedic.ch.

The form, content and frequency must be agreed with Swissmedic.

Manufacturers of Class IIa, IIb and III devices according to the Medical Devices Ordinance (MedDO; SR 812.213) and manufacturers of Class C and D devices according to the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) are required to prepare a Periodic Safety Update Report (PSUR) for each device and, if appropriate, each device category or group, and to submit the report to the responsible designated body.

On request, the manufacturer or its authorised representative must submit the PSUR or the assessment result of the designated body to Swissmedic.

If a manufacturer or SPPP of a device according to MedDO/IvDO conducts a Field Safety Corrective Action (FSCA) involving devices available on the Swiss or Liechtenstein market, it must notify Swissmedic of the FSCA without delay.

For manufacturers or SPPPs who are not based in Switzerland or Liechtenstein, the authorised representative assumes responsibility for this task. In this case, the report can be submitted by the manufacturer, the SPPP or their authorised representative.

Further information can be found in this guidance document:

To report an FSCA to Swissmedic, complete the following form in English or one of the Swiss national languages and send it electronically and in machine-readable format to materiovigilance@swissmedic.ch. Manufacturers or SPPPs not based in Switzerland or Liechtenstein must include the authorised representative in the mailing list using the contact details provided in section 5 of the form.

A template for Field Safety Notices (FSNs) can be found on the EC website in the "Guidance MEDDEVs" section under 2.12 "Post-Market Surveillance".

http://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en

Here, you will also find templates that customers can use to confirm receipt of the FSN.

The templates are intended to assist manufacturers or SPPPs in producing good-quality customer letters that contain all the necessary information.

FSN requirements for publication

In accordance with Art. 67 of the Therapeutic Products Act (TPA; SR 812.21), Art. 90 let. g of the Medical Devices Ordinance (MedDO; SR 812.213) and Art. 73 let. g of the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219), Swissmedic will publish safety advice issued to customers concerning recalls/FSCAs taken on its website at https://www.swissmedic.ch/md-fsca-en.
The following should be taken into account for documents to be published by Swissmedic:

• Only one (1) machine-readable PDF document should be submitted per language.
• The document must include the following elements:
  • FSN explaining the facts
  • Form for confirmation of receipt of the FSN by the customers (if no such form is envisaged, we expect an explanation of how follow-up of the FSCA will be ensured)
  • Other attachments such as product or batch lists (if necessary).

The manufacturer or SPPP or their authorised representative is responsible for the content (accuracy, completeness and data protection). The FSN must not contain any information that would conflict with data protection provisions in the event of publication.

Information such as customer details, names of individuals, personalised e-mail addresses, personal telephone numbers and signatures must be removed or redacted before publication.