The Commission just published a Flowchart to assist manufacturers and stakeholders in determining device coverage under the extended transitional period of the MDR.
The purpose of the flowchart is to aid manufacturers and other relevant stakeholders in making a determination about the inclusion of a device within the extended transitional period outlined in Article 120 of Regulation (EU) 2017/745 on medical devices (MDR), as revised by Regulation 2023/607. This flowchart is designed to facilitate the assessment of whether certain devices meet the criteria, adhere to the stipulated conditions, and meet the specified deadlines for the placing on the market or putting into service as outlined in Article 120 of the MDR.
While using the flowchart you are advised to refer to the MDR text, which holds precedence over the flowchart, as well as to consult the Q&A addressing practical aspects related to the implementation of Regulation (EU) 2023/607.
MDSS provides assistance in going through the flow chart or the Q&A to ensure the accurate application of the extension and the establishment and availability of the relevant documentation, which may be requested by authorities and other parties such as importers.
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