Submission of a report
An accident with a medical device shall mean the unexpected operation or effects of any medical device by any manufacturer, as well as any inaccuracy in the label or instructions for use which, directly or indirectly, caused or could have caused the death of the device user or another person or a serious health disorder.
The user of any accident or potential accident device related to the use of a medical device shall notify the State Agency of Medicines within three days of the accident, as well as inform the manufacturer or the authorised representative of the manufacturer or distributor thereof.
Patients shall complete the form of the report: “Persons who use a medical device independently or according to the instructions of a medical practitioner, vigilances a system signal of an accident associated with a medical device” and sending it to an e-mail address: info@zva.gov.lv.
If the user of the medical device is a medical treatment institution, it shall complete the “Vigilances System Signal” and submit it to the website of the State Agency of Medicines at www.zva.gov.lv.
In order to facilitate the assessment of whether an accident occurring in a medical treatment institution is related to the use of a medical device and whether it is necessary to notify the State Agency of Medicines regarding the specific accident, a request to refer to THE LIST OF CONTROL QUESTIONS.
The service is free of charge.
Documents to be submitted
Documents to be submitted