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PDF Proxy Card Templates to Download in 2024

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Aug 6th, 2022

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welcome to the medical device Made Easy podcast I am munira lazuzi and today we will perform the February 2023 regulatory update for medical devices [Music] okay are you aware that the EU commission is proposing to extend the umdr from May 26 2024 until December 31st 2027 for class 2B and class 3 and until December 31st 2028 for class to be other than the one previously mentioned and for class 2A so if you are not aware then you are aware but you have to follow certain conditions to be able to do that so the first condition is that the device should or comply to the regulations so mddamd the second is that there is no docHub changes that apply to your device that there is no unacceptable risks that your company has a quality management system that follows the article 10 9 of the umdr prior to the 26th of May 2024 that also and this may be the most difficult an application has been lodged with the notified body prior to the 26th of May 2024. but maybe you are also in the condition

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