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 […]
I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described. The new guidance The MDCG has […]
Last week we finally had some new interesting developments (sorry for the boring silence on this blog but there was really nothing to report): the new Commission has completed and we are getting some first glances into how the new Commission sees EU medical devices policy going forward. With the unveiling of the new #teamjunkcer of […]
Here is some follow up on the previous Blue Guide post: the new version of the Blue Guide is the first to address software updates to CE marked products, including software. For the purpose of this blog this would typically be standalone software that constitutes a medical device in the meaning of MEDDEV 2.1/6. Harmonised standards […]
After a royal time of suspense, the new Blue Guide has finally arrived. Was it worth the wait and what is new and noteworthy in medical devices? Let’s see. I will take you through this substantial document in a number of blogs, of which this is the first. Some history But first, for those who are […]