Incident reports 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).
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 2.12-1 of 6 december 2009 (MEDDEV 2.12-1), which can be found at the EU website.
The Inspectorate requests you to use the standard questionnaire form included in the MEDDEV (see link below) 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.
The additional information the Inspectorate may request for, can be found in the questionnaire below. This questionnaire contains standard questions which are relevant to the situation in the Netherlands. Additionally, it contains questions which are also covered in the MEDDEV report format for FSCA's. If you use this format, you only need to answer those questions that are applicable to the situation in the Netherlands. In case you wish to report an incident that occurred in the Netherlands, the information provided via the Incident report format will suffice.
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
3500 GR Utrecht
Faxnummer: +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.