European Commission. Today, the Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation. The new deadlines depend on [...
BSI Medical Devices provides quality management reviews and CE certifications for medical device manufacturers around the world, and we can do it for you too.
Various regulatory bodies provide definition of this term such as US Food and Drug Administration (US FDA), World Health Organization (WHO), and European Commission (EC) which gives the most comprehensive one. Medical devices have become a critical component of health care, as they enable health...
The European Database on Medical Devices (EUDAMED) is the IT system developed by the European Commission as an integral part of MDR and IVDR implementation.
European Commission Newsletter on medical devices | October 2024 Thursday, October 31st 2024 News European Commission Newsletter on medical devices | October 2024 This newsletter from the European Commission aims to provide highlights and updates from the medical devices and in vitro (...) ...
Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices 1 and Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices 2 were adopted on 5 April 2017 and entered into force on 25 May 2017. Regulation ...
The European Database on Medical Devices (EUDAMED) is a database managed by the EU Commission for the storing of information about medical devices. The aim of EUDAMED is to strengthen market surveillance by providing competent authorities with fast access to information on manufacturers, authorized ...
Introduction The European Commission has published a factsheet addressed to competent authorities of third countries.
European companies and products and said the probe came after its repeated discussions with China on its procurement market for medical devices have been fruitless. The Commission said evidence it gathered indicates China’s procurement market for medical devices has gradually become more closed for ...
TMTPost -- The European Union may open another investigation into Chinese products right after the probe into electric vehicles (EVs). Credit:Xinhua News Agency EU may announce launch of an investigation into China’s procurement of medical devices as soon as this week and could lead to the bl...