Articles



Article

But weren’t they supposed to vote on it on the 14th?

Short update on the MDR amendment proposal because quite a lot of people were expecting the European Parliament to take a final vote on the MDR amendment proposal today. A lot of them that watched the vote on the Parliament’s streaming services were surprised and disappointed that the vote seemed unclear: no vote on the […]

Article

The MDR proposal for extension – “Can the maker repair what he makes?”

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 […]

Article

The Blue Guide 2022 update – new elements regarding applicability of EU law on products

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, […]

Article

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 […]

Article

Managing the 2024 MDR danger zone – and outlines of a potential solution in MDCG 2022-11

We live in interesting times for medical devices in the Union – some have said we are headed for a cliff edge at the end of the grace period. I would personally prefer to say that we are in the danger zone, which would be a zone of danger (Archer pun on Top Gun), but […]

Article

MDCG 2021-27 Q&A on importers and distributors – sort of box of chocolates

Life, as they say, is like a box of chocolates: you never know what you’re going to get. MDCG guidance documents are very much like that too. Even if you’ve seen them coming in the consultation phase the end result may still surprise you. Some are really good, some are really good and complex, some […]

Article

The Enriched MDR and IVDR – finally available

Finally and just in time for the date of application of the MDR: here it is, the book that I’ve been working on for a long long time. It turns out that writing books while having a more than full-time job running a law firm and being a busy lawyer is a bit of a […]

Article

MDR date of application next month – and the book

Finally! Another post on this blog. You would think that I would write a lot on a blog like this just before the date of application of the MDR next month, right? Well, I did – just not on the blog but I was working hard to finish my book on the MDR and IVDR […]

Article

Outlook for 2021 – and happy new year!

Something new for the end of the year: a new year’s vlog with my rough 2021 outlook. This outlook is far from complete and not comprehensive at all, and it leaves out many other important things. Make sure to stay informed (or as Kant the philosopher said: dare to be wise)! If you like this […]

Navigate through our knowledgebase