The rules for putting medical devices and IVD products on the market in EU are drastically changing very soon. The new regulations are adding many new requirements for all manufacturers but specific for the ones in the lowest risk class. This presentation discuss the overall changes vs today and a few critical considerations companies needs to do going forward. Unlike many other countries many software apps are getting regulated in the same way as traditional medical devices. For these devices there are still a few months to be registered according to the old regulation (25 May 2021) and hence be able to sell the product to 25 May 2024.
Speaker: Peter Löwendahl, Clever Compliance - SWEDEN
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