28.09.2023 - 12:06   /   1,486

European Commission has published on 23 August 2023 a Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period.

The flowchart is intended to assist manufacturers and other relevant actors in deciding whether or not a device is covered by the extended transitional period provided for in Article 120 of Regulation (EU) 2017/745 on medical devices (MDR), as amended by Regulation (EU) 2023/607. This flowchart will help to determine the eligibility, conditions and deadlines for the placing on the market or putting into service of certain devices in accordance with Article 120 of MDR.

You can access the mentioned flowchart using the link below:

https://health.ec.europa.eu/system/files/2023-08/md_devices-art120_flowchart_0.pdf