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IVDR amendment proposal update: moving on up to adoption
I recently reported about the proposal to amend the IVDR immediately when it came out – please excuse the initial inaccuracies in the post on the subject of amendments to article 5 (5) IVDR (in-house...
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Proposal to manage IVDR
It had been been in the works for some time, although it also seemed unlikely for quite some time that this would happen. The implementation of the IVDR had been the slow little, neglected sister of...
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The new EU AI regulation proposal, medical devices and IVDs
Now this is fun: at a time just before the date of application of the MDR when we do not even have harmonised standards for the new software requirements in Annex I, section 17 MDR and Annex I,...
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Date of Entry into Force plus three years and a little bit
MDR DoA moved: industry be like Last week we went past DoE (Date of Entry into force) of the MDR plus three years, and the date on which the MDR was supposed to have become applicable. As you, my...
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Batman MDR and IVDR update after the first MDCG / stakeholders meeting and an...
You must be thinking that this blog is a bit quiet while a lot is happing – and that’s exactly the case. I’ve been very very busy being Batman (see picture on the left). A lot of companies in devices...
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The final text of the IVDR: first impressions
The IVDR text that the Council, Commission and Parliament reached agreement on is finally public (since 15 June). I’ve had the time to read it now. I am not going to draft a long summarizing article...
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EU Council also thinks genetic testing amendment in IVD regulation proposal...
In a previous blog I have addressed the genetic testing amendment to the IVD regulation proposal and have provided argumentation why this proposal is outside the scope of the legislative competence of...
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The genetic testing amendment in the IVDR
The focus of the EU revision of medical devices regulation is fully on the medical devices regulation. The revision of the IVD directive is sort of happening in the background and is not getting the...
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EU companion diagnostics regulatory developments – the movie
Now that my firm Axon Lawyers has a YouTube channel, why not use it more? I was recently invited as speaker to the DIA Meeting on Personalized Medicines and Companion Diagnostics in Washington DC...
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Euro update and Don’t Lose The SME
While the medical devices and IVD regulation proposals trickle through the legislative process and people concentrate on details like I have done on this blog as well, it might be nice to have a...
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ENVI’s IVD regulation amendments
As promised, here is an analysis of the IVD amendments further to the report provided by rapporteur Liese, with numbers 75-237 and 238-399. Not that as many as the medical devices ones, but still a...
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The fog of war following a tsunami of amendments
‘A speedy market access procedure of only this long.’ That’s a good term to describe a situation of limited situaltional awareness resulting from many things happening at the same time very quickly,...
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Rapporteur Liese’s IVD regulation amendments are out: not so horizontal as...
Now that rapporteur Roth-Behrendt’s proposed amendments for the medical devices regulation proposal are out, it could not take long for rapporteur Liese’s amendments for the IVD regulation proposal to...
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The IVD regulation proposal in a nutshell
With this post I would like to make good on a promise I made some time ago: that I would also do an analysis of the proposed IVD Regulation in more or less the same level of detail as I did for the...
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What to expect in the new EU in vitro diagnostics regulation?
Our seminar on IVD legal and regulatory issues of 12 september was a big succes. We had the passionate story of Henk Viëtor about Skyline Diagnostics’ efforts to bring its products to the market and...
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In Vitro Diagnostics seminar at Axon Lawyers on 12 September
Dear readers, I hope you don’t mind some modest self-promotion: my firm is organising a seminar on EU recent (and future) legal and regulatory developments with respect to in vitro diagnostics, with...
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