On 6 January 2023 it finally happened: the moment that many had been waiting for – the MDR extension proposal finally dropped (see here for Commission provided background). It did not turn out to be what I expected in all respects. First, it contained also an amendment to the IVDR: a removal of the sell-off […]
As announced in my previous blog post providing a general overview of my impression of the changes made in the Blue Guide 2022 compared to the previous 2016 version, this blog post follows up in detail on the changes in Chapter 2. Chapter 2 of the Blue Guide explains when EU law on products applies, […]
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 […]