Documents - Medical Technology

Call to medical device manufacturers: implement an effective PMS system

The Health and Youth Care Inspectorate (IGJ) supervises post-market surveillance (PMS) at manufacturers of (in-vitro diagnostic) ...

Publication | 08-10-2024

Appeal to manufacturers: take action to meet IVDR requirements

The Dutch Health and Youth Care Inspectorate (IGJ) has conducted a survey of Netherlands-based manufacturers of medical devices ...

Publication | 05-09-2023

IGJ assessment framework: Deployment of eHealth by healthcare providers

The assessment framework in this booklet is the starting point for supervision by the Dutch Health and Youth Care Inspectorate ...

Publication | 25-11-2021

FAQ about inducements (Medical Devices Act)

Report | 28-05-2021

IGJ position on textured and smooth breast implants and BIA-ALCL

At the beginning of this year, scientific research was published that shows that there is a link between a certain type of cancer ...

Position statement | 26-11-2018

Frequently asked questions about sterilisation product Essure

Publication | 28-06-2018

Questions and answers RIVM report Silicone breast implants

Publication | 14-02-2018

Questions and answers: Update of the RIVM report ‘Silicone breast implants in the Netherlands: A market surveillance study’

The information below belongs to the RIVM report that is published on 12 February 2018 on the website of RIVM.

Publication | 12-02-2018

Follow-up RIVM report “Silicone breast implants in the Netherlands - A market surveillance study”

Publication | 13-10-2017