Transition timelines connected to Regulation (EU) 2017/745 on medical devices (MDR) have become a complex issue. Back in March, Regulation (EU) 2023/607 became applicable thus introducing – among others – new transition timelines for MDR legacy devices.
Please find below a brief summary of the most recent updates on the aforementioned topic.
Revision 1 of document Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices has been published with further clarification and specification. We will issue a separate newsletter article shortly.
The European Commission has updated its Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices to help competent authorities outside the Union to understand the provisions of the extended transition period. We will issue a separate newsletter article shortly.
The European Commission has published a flowchart Conditions and deadlines for placing ‘legacy devices’ and class III custom-made implantable devices on the market or putting them into service in accordance with Article 120 MDR, as amended by Regulation 2023/607 to help involved actors to understand if medical devices can make use of the extended transition period. Please let us know should you need the flowchart document or require assistance in understanding the underlying requirements.
Manufacturers that may make use of the extended transition period, should be able to present a self-declaration and – depending on the type of legacy device – a declaration issued by the notified body. The corresponding associations and industry groups have set up templates that correspond to the requirements. Should you need one of the templates, please let us know.
Source: European Commission