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Amanda Maxwell

London, UK

A lifetime dedicated to passionately following medtech regulations seems a big claim, but Amanda Maxwell, regulatory affairs editor, wears the badge and has a loyal list of followers. She still remains as passionate about the implications of changing requirements as 30 years ago when analysing the drafting of the first EU medical device and IVD rules. She tirelessly picks through the draft and existing requirements and the implications of the background debate, to bring you the reality of what the latest developments and discussions mean for you. Amanda knows where to get the vital information, who can offer the best inside knowledge and how to get it to readers quickly. She is well respected in the industry and has a history of moderating and chairing at many high-profile meetings in the EU and the US ( MedTech Forum (EU), AdvaMed (US), DIA (EU and US)), and a strong network of contacts among regulators, consultants, lawyers and EU institutions. She has also been active in consulting and training companies in EU medical device regulations. Amanda has been known to pick up stories while swimming in the Aegean, and there are rumours of her renting a window cleaning scaffold outside the European Commission, but she won’t comment on this and would not recommend anyone to try it!

When not writing, Amanda is a strong well-being advocate and loves health and wellness apps. She rarely sits still and loves to be out and about, actively participating in life with family and friends.

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Given the ongoing conflict in Ukraine, EU medtech notified bodies have been told to comply with sanctions intended to hurt companies based in Russia and Belarus.

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Hot Topics On The EU’s Immediate Regulatory Agenda: Six Documents To Endorse

Vital MDR and IVDR implementation documents and measures are listed for endorsement at the forthcoming meeting of the European Commission’s Medical Device Coordination Group.

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MedTech Forum 2022: How Regulatory Complexity Is Crushing The EU

Is it time to reflect on how the EU can take measures to escape a situation where regulation threatens innovation, product availability and product costs and to stop this trajectory of ever increasing the regulatory bar?

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Updated: EU IVD Regulation Guidance On Significant Changes Now Available

With just a few weeks to go until the IVD Regulation fully applies, much-needed guidance has been published which discusses “significant changes” for legacy IVDs

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