Legacy Device MDR Transition Flowchart

The EU Commission has released a helpful flowchart to help manufacturers understand whether or not they are eligible for the new Article 120 extensions.

The purpose of this flowchart is to assist manufacturers and relevant stakeholders in determining whether a device falls under the extended transitional period outlined in Article 120 of Regulation (EU) 2017/745 on medical devices (MDR), as amended by Regulation 2023/607. It aims to aid in understanding the eligibility criteria, conditions, and deadlines for market placement or service commencement of specific devices as per Article 120 MDR. Users are advised to refer to the MDR text, which takes precedence over the flowchart, and consult the Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607.

If you require assistance in determining whether or not you are eligible, get in touch with our team!