Article

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

15 Feb 2023, 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…

Article

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

15 Feb 2023, Erik Vollebregt

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?”

17 Jan 2023, 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…

Article

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

15 Jan 2023, Erik Vollebregt

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

MDR and IVDR outlook for 2023

01 Jan 2023, What to expect for the MDR and IVDR in 2023? Predictions are very hard, especially if they are about the future. That’s a paraphrase of a very solid Danish nugget of wisdom…

Article

The EPSCO meeting and beyond: further steps for the MDR and IVDR implementation regime changes

11 Dec 2022, The 9 December EPSCO meeting in which the Commission was going to make its big reveal to fix the MDR came and went and left many people with a lot of conflicting…

Article

Focus on the authorised representative

06 Nov 2022, Last week we saw publication of the new MDCG guidance on the authorised representative under the MDR and the IVDR, MDCG 2022-16. My first impression: much about the ‘what’ and not so…

Article

The 2nd edition of The Enriched MDR and IVDR is available now

27 Oct 2022, It took a while, but here it is: the 2nd edition of The Enriched MDR and IVDR, updated with developments from early april 2021 to early September 2022. The first edition of…

Article

The New Product Liability Directive(s) proposals and medical devices / IVDs

09 Oct 2022, On 28 September the Commission adopted two related proposals for EU regulation of no-fault liability for defective products. One proposal updates the ‘old’ Product Liability Directive (PLD) from 1985 to make it…