During 2022, there had been little that had been straightforward when it came to the implementation of the EU’s new Medical Device and IVD Regulations. Originally due to first apply in 2020 and 2022 respectively, the slow rate of preparedness of the system and of its players resulted in warnings about products having to be unnecessarily withdrawn from the EU market and continuous calls to extend deadlines throughout the year.
As 2022 was drawing to a close, the volume of noise from the industry, notified bodies and even national regulatory authorities calling for extensions in the deadlines for compliance with the
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