Skip to main content
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Dutch IGJ: Appeal to manufacturers: take action to meet IVDR requirements

By September 22, 2023No Comments

The Dutch Health and Youth Care Inspectorate (IGJ) plans to conduct inspections to assess whether Netherlands-based manufacturers comply with IVDR requirements on vigilance and post-market surveillance.

This announcement was made following a survey they conducted involving Netherlands-based manufacturers of IVDs to understand the status of the transition to Regulation (EU) 2017/746 IVDR. A summary of the results have been published on the IGJ website.