Article

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

07 Aug 2022, Erik Vollebregt

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, […]

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The MDCG cybersecurity guidance – a helpful rush job

16 Mar 2020, Erik Vollebregt

It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […]

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Dwaaldetectie

11 May 2016, Karin Verzijden Onderstaand artikel is op 11 mei 2016 gepubliceerd in de nieuwsbrief van eGPO. ‘Tijdens het juridisch inloopspreekuur in de Zorginnovatiewinkel op 13 april werd aan mij (Sofie van der Meulen, Axon science based…

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In, on and near body networks EU regulation

19 Nov 2014, Erik Vollebregt I had the pleasure of being invited to speak at the Health IT forum at the MEDICA conference last week on regulation of in, on and near body networks. Most of my…

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Surprise! More on unannounced audits, this time on software

10 Oct 2014, Erik Vollebregt Further to my recent posts on unannounced audits I have been thinking about how unannounced audits could play out in an area that becomes more and more important: standalone software. Software medical devices…

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New EU Commission guidance on medical devices borderline products and classification

06 Sep 2014, Erik Vollebregt Yesterday the European Commission’s Working Group on Borderline and Classification issued the new version (1.10) of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. This manual…

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Updates, patches, add-ons, plugins & the Blue Guide

14 Aug 2014, Erik Vollebregt 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…

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The MHRA's new guidance on standalone software as medical device and DIA Euromeeting update

27 Mar 2014, Erik Vollebregt A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device. The guidance of course has to color between…

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IMDRF Software as Medical Device definition document completes

13 Jan 2014, Erik Vollebregt In relative quiet the IMDRF has delivered its first deliverable in the series of documents relating to Software as a Medical Device (SaMD) on 18 December last year, together with a number…