Documents

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

Authorised representatives of medical devices do not always meet the basic requirements

Authorised representatives are an essential link in the chain of ensuring safe and effective medical devices across the European ...

Publication | 15-05-2024

GLP domestic test facilities

Publication | 07-05-2024

IGJ Policy plan 2024-2027

A great deal is happening in the world – both close by and in far-flung places. These are developments that likewise have an ...

Publication | 21-12-2023

GLP: Non-domestic test facilities

Publication | 02-10-2023

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

Template for Risk-Assessment Questionnaire Pharmacovigilance

This template is to help marketing authorization holders (MAHs) during the collection of information from different departments ...

Publication | 02-02-2023

Notice to manufacturers nasal and mouth sprays

The Health and Youth Care Inspectorate as market surveillance authority for medical devices in The Netherlands, would like to ...

Letter | 14-11-2022

Restrictions in IGJ on-site inspections due to safety risks

During national or international crises, on-site GxP inspections may not be possible for a number of reasons such as travel ...

Publication | 20-09-2022

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