Until a corresponding special ordinance (In-vitro Diagnostics Ordinance, IvDO) is issued, two different versions of the Medical Devices Ordinance have been in force since 26.5.2021:
Anyone placing medical devices on the Swiss market as a manufacturer or distributor must report all incidents to Swissmedic.Further information can be found via the following link:
A detailed description of the procedure is also provided in the European vigilance guidelines MEDDEV 2.12/1. The rules described in these guidelines also apply to Switzerland.
Since July 2019, moreover, the following additional guidance has been available: Update on MEDDEV 2.12/1 rev. 8. Among other things, this document clarifies a number of definitions and provides links to the latest forms.
If you wish to report a serious incident to Swissmedic, please complete this MEDDEV template in full, preferably in English or one of the Swiss national languages. Then click the “Submit XML by Email” button at the end of the template and send the XML file that is generated and the PDF to materiovigilance@swissmedic.ch:
Detailed information on each point of the form and the needed codes can be found in the helptext:
The European Commission has created a document containing answers to frequently asked questions regarding the use of the new reporting form for serious incidents and IMDRF codes.
A manufacturer of a device made available in Switzerland must report any serious incidents that occurred in Switzerland to Swissmedic: (materioviglance@swissmedic.ch). For manufacturers who are not based in Switzerland, the Swiss authorised representative assumes responsibility for this task. In this case, the report can be submitted by the manufacturer or the Swiss authorised representative. Further information can be found via the following link:
For incidents that are classed as serious and that have occurred in Switzerland, 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 a Swiss authorised representative or manufacturer based outside Switzerland, 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 Swiss authorised representative should be entered in section 1.3.4 "Submitter's details".
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 new reporting form for serious incidents and IMDRF codes.
An Information sheet on Trend Reports and Periodic Summary Reports can be found via the following link:
Any manufacturer or first placer on the market who notices a significant increase in the incident rate (reportable and non-reportable incidents) must report this trend and any corrective actions to Swissmedic and the responsible competent authority (authority of the country in which the manufacturer or the European representative is based).
If you wish to report a trend to Swissmedic, please complete this MEDDEV template, preferably in English or one of the Swiss national languages, and send it to materiovigilance@swissmedic.ch:
Periodic Summary Reports (PSRs) are summarised reports of incidents by period that have already been the subject of a Field Safety Corrective Action (FSCA) or Field Safety Notice (FSN), or that are generally known and documented. The first placer on the market must coordinate PSRs with the relevant authorities and must obtain their consent before reporting by means of PSRs.
If you wish to initiate a PSR, please complete this MEDDEV template, preferably in English or one of the Swiss national languages, and send it to materiovigilance@swissmedic.ch:
If a manufacturer notices a statistically significant increase in the frequency or severity of non-serious incidents or expected undesirable side effects, the manufacturer must report this to Swissmedic using the following form (materiovigilance@swissmedic.ch). For manufacturers who are not based in Switzerland, the Swiss authorised representative assumes responsibility for this task. In this case, the report can be submitted by the manufacturer or the Swiss authorised representative.
Similar serious incidents that meet the following criteria can be grouped together and reported as Periodic Summary Reports (PSR):
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 discussed with Swissmedic.
MU680_23_001e_FO MEDDEV Template Periodic Summary Report (PSR) (DOC, 89 kB, 26.05.2021)(Reporting Template)
Manufacturers of class IIa, IIb and III devices are required to prepare a Periodic Safety Update Report (PSUR) for each product and, if applicable, each product category or group, and to submit the report to the responsible notified body.
On request, the manufacturer or its Swiss authorised representative must submit the PSUR and the assessment result of the Notified Body to Swissmedic.
If a manufacturer or first placer on the market arranges a recall of a medical device or some other safety measure (FSCA) involving a medical device that is either manufactured in Switzerland or is available on the Swiss market, this must be reported to Swissmedic without delay.
Additional information can be found in this Information sheet:
If you wish to report an FSCA to Swissmedic, please complete this MEDDEV template in full, preferably in English or one of the Swiss national languages. Then click the “Send XML-data by e-mail” button at the end of the template and send the XML file that is generated and the PDF to materiovigilance@swissmedic.ch:
Since the end of 2018, a new template for the customer letter (Field Safety Notice, FSN) required for the FSCA (Field Safety Corrective Action) has been available on the EU website. This template is to be used for letters to physicians and other healthcare professionals. See:
http://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en
and go to “Guidance MEDDEVs” in the section 2.12 “Post-Market Surveillance”.
On the same page, you will also find templates for customer and distributor reply letters plus a questions & answers document.
The FSN template and the templates for customer and distributor reply letters are intended to assist manufacturers in producing good-quality customer letters that contain all the necessary information. Using the template is not compulsory, but manufacturers are nevertheless requested to use it whenever possible.
If a manufacturer of a medical device conducts a Field Safety Corrective Action (FSCA) involving affected devices on the Swiss market, it must notify Swissmedic of the FSCA without delay.
For manufacturers who are not based in Switzerland, the Swiss authorised representative assumes responsibility for this task. In this case, the report can be submitted by the manufacturer or the Swiss 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 submit it electronically and in machine readable format to materiovigilance@swissmedic.ch:
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 a template that customers can use to confirm receipt of the FSN.
Templates are intended to aid manufacturers in drafting good-quality customer letters with no omissions.
