Medical technology is about products, technologies and applications used in the diagnosis, treatment and support of diseases and disorders. The Inspectorate monitors the safety of medical devices as well as safe use thereof by healthcare professionals.
Spotlight
Authorised representatives of medical devices inspected
The IGJ inspected 24 authorised representatives acting on behalf of more than 3 manufacturers in relation to specified tasks with regard to the latter’s obligations under the MDR/IVDR. These representatives do not always meet the basic requirements. The IGJ outlines specific actions for improvement.
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Call to medical device manufacturers: implement an effective PMS system
For medical device manufacturers, it is essential to have a well-functioning post-market surveillance (PMS) system. This minimises the risk of injury for users of the medical devices.
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