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Ceci n’est pas une période de transition and first reaction to the Implant Files
As we are just past the halfway point of the MDR transitional period for the MDR and are well into the one for the IVDR there is one thing that has become very very clear: the transitional period in...
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MDR and IVDR in 2019: up or out, sink or swim
Happy new year and welcome to 2019, a truly decisive year for the medical devices industry with interests in the EU. If you haven’t spent any time so far getting ahead of events relating to the MDR and...
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First notified body EU MDR designated!
BSI reports that it has achieved designation as UK notified body for the MDR. So far, it’s the first notified body to appear in the NANDO database with an MDR designation – see here for scope and here...
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Don’t give me Brexit problems, give me Brexit scenarios
At the moment I spend a considerable amount of my lawyering time answering questions concerning Brexit problems. My first question back to the company is: what are your Brexit scenarios? Did you make a...
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Bottleneck of bottlenecks for notified body capacity
People that are downplaying the notified body bottleneck may need to start to revisit their position with notified body LRQA now also dropping out of the notified body pool for medical devices and...
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A not so happy MDR and IVDR Christmas Carol
MDR and Article 123 (3) (d) cookies courtesy of Medtech Europe’s Katalin Maté who baked them for a meeting – they were delicious! Just before the Christmas holidays the Commission updated its rolling...
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Welcome to 2020 – year of the proof of the MDR pudding
Welcome to 2020 – happy new year everyone. I don’t care if your conventions do not allow me to wish you best wishes after a certain date anymore. I wish you a happy 2020 because I genuinely hope you...
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The MDR and the Covid-19 recommendation – a possible template for fixing the...
On 16 March 2020 the Commission published the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19...
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New MDCG guidance on temporary extraordinary measures related to medical...
When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel...
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Finally remote initial audits, or not (yet)?
When the Commission recently published the Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits...
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Happy IVDR day!
Happy IVDR day my readers! My apologies for the low level of activity on this blog the last time. I’ve been very busy with MDR and IVDR work. And of course I have been working hard on the second...
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