European commission has now official published the Q&A on practical aspects related to the implementation of regulation 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.
The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out, in accordance with the MDR, the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC. Moreover, the deletion of the ‘sell off’ date in the MDR and the IVDR aims to prevent unnecessary disposal of safe devices.
The answers to the questions set out in the document have been developed by taking into account the objectives pursued by the amendment with a view to making best use of the additional time provided by the extension of the MDR transitional period.
Read more about it here: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
If you would like to know more or need someone to discuss this further with,
don’t hesitate to contact Annelie Hagström here.