Medical technologyReport incidents and field safety corrective actions
Vigilance forms are an important component of post-marketing surveillance.
Manufacturers are obliged to report any of the following circumstances to the Inspectorate
- any malfunction or deterioration in the characteristics and/or performance of a medical device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user, or to a serious deterioration in his state of health;
- any technical or medical reason in relation to the characteristics or performance of a device further to the first point (above) that has prompted the manufacturer to withdraw devices of the same type from circulation (product recall).
Report an incident
Agreements have been made between the industry and the relevant authorities with regard to the manner in which the reporting requirement is to be fulfilled, and the action to be taken upon receipt of a report. The basis for all vigilance activities is the Guidelines on a Medical Devices Vigilance System (MEDDEV).
The Inspectorate requests you to use the standard questionnaire form included in the MEDDEV and to answer all questions as fully as possible. This will ensure that further correspondence can be kept to a minimum. The Inspectorate may contact you should any supplementary information be required.
Report a FSCA
If you take an action to repair a defect or lack of your product, you must report this to the Inspectorate. For example overall product recalls or changes in the design, manual or packaging of the product. For more information about reporting corrective actions for medical devices, please consult the European guideline (PDF file, 889 KB).
You can report corrective actions with a standard form (PDF, 1.35 MB). Fill in the form digitally and store it. Then add the form as an attachment to an e-mail message. You can also add other attachments that are important to the alert. Send the e-mail to firstname.lastname@example.org. An explanation of the form (PDF, 12KB, English) is also available on the European Commission website.
You are requested to send your report and other correspondence regarding vigilance cases, by e-mail, to email@example.com, or by post or fax to:
Inspectie voor de Gezondheidszorg
6401 DA Heerlen
Faxnumber: +31 (0) 88- 120 50 01
If you have questions please contact us. During office hours: 088 -120 5000.
Outside office hours the inspectorate can be reached through de ministerie of Health, in case of an emergency only: +31 (0)70 – 340 5050.