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The MDCG guidance on significant changes – a significant change?

It’s hard to keep up with all the work and the new publications of guidance these days. Abundance creates its own problems one could say, so that’s why this blog was slightly delayed. Due to the COVID-19 epidemic I have had to home quarantine the family, move the whole law firm to a virtual platform […]

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The MDR and the Covid-19 recommendation – a possible template for fixing the MDR and IVDR bottleneck

What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would…
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The MDR and the Covid-19 recommendation – a possible template for fixing the MDR and IVDR bottleneck

What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]

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New MDCG Class I Article 120 (3) and (4) MDR guidance – nothing new but nice summary of requirements

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,…
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New MDCG Class I Article 120 (3) and (4) MDR guidance – nothing new but nice summary of requirements

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 […]

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The MDCG cybersecurity guidance – a helpful rush job

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…
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The MDCG cybersecurity guidance – a helpful rush job

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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The MDCG MDR joint implementation plan

The MDCG just published a joint implementation plan regarding the MDR. Here is my summary and analysis. It’s not a happy story. Not the IVDR This implementation plan is not about the…
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Brexit is a fact – now deal with it

Following the European Parliament’s vote, the Council as now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parlementarians…
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