Hi Monir, I’m from Poland and I’m looking for any information (maby are there any guidelines or directives) about medical devices stability data, in-use testing, how they should to be research? And how base on this information set an expiration date of medical device?
@ChristianMicheletti-ly3hf
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Hi Monir, If I read the UK government answer, I get that MDD devices can be sold only with CE up until CE certificate validity, meaning May 2024. Since our CE certificate is now valid up to 31.12.2028, do you think UK will not take there into consideration and allow CE-only to that date for MDs for Class IIa and below?
@EasyMedicalDevice
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Hi Christian, I think UK already moved out of CE marking in their mind. So from mid 2024 everyone that is not UKCA cannot be marketing its devices in the UK. For now they are just accepting CE certificates that expired but are compatible with the extension.
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