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 2023/607.
The flowchart should 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 MDR.
The user of the flowchart is advised to consult the text of the MDR, which takes precedence over the flowchart, and the Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607.