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Articles Tagged: MDR

MDR and IVDR Communication Survey

The EU Commission published a survey in August 2023, this survey is due to close by the end of November 2023. It is only intended for stakeholders who are directly impacted by the regulatory changes for medical devices. That would seem to be a great number of organisations. The object of this survey is to ...

Advena Guidance on Regulation (EU) 2023/607

This amendment was introduced to address the projected shortage of medical devices on the market in the coming years and to address the limited capacity of the notified bodies. Since its introduction in March, there have been some notable updates that manufacturers should be made aware of. Advena has created a guidance document that will help ...

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