medicaldeviceslegal

The new Blue Guide 2022 – not much new for devices and IVDs, but certainly more confusion

In short After approximately six years after the previous (2016) version of the Blue Guide the 2022 version finally ‘dropped’ on 29 June 2022 in the Official Journal edition C edition of that day. I will discuss new and amended headings and subjects in the Blue Guide 2022 compared to the 2016 version in a series of blogs that are to follow this one, which serves to give you a general initial overview. Spoiler: in short the Blue Guide 2022 does not provide a lot of new things for devices in [...] « Read the rest of this article on medicaldeviceslegal »