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  1. 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

  2. GLP domestic test facilities

    Publication | 07-05-2024

  3. 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

  4. GLP: Non-domestic test facilities

    Publication | 02-10-2023

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. FAQ about inducements (Medical Devices Act)

    Report | 28-05-2021