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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Latest From Amanda Maxwell
The recent document from the European Commission's Medical Devices Coordination Group concerning device registration timelines is difficult to follow, with its many unexplained references. This article aims to clarify how the MDCG's findings affect the way manufacturers should prepare for MDR compliance.
With just over 13 months until the EU Medical Devices Regulation is fully applicable, EU medtech manufacturers are imploring the European Commission to speed readiness of the new regulatory system or patients and industry will suffer.
The new EU medical device regulations ̶ the MDR and IVDR – left a gap in how manufacturers of legacy products should comply with critical reporting requirements. A solution has been found.
Has the European Commission done enough to allow UK-certified medical devices to continue on the EU27 market in the event of the UK dropping out of the EU without a deal – a possibility that remains very real?
Will Eudamed, the European Database for Medical Devices, offer a free source of information for competitors which disadvantages original companies? Vincenzo Salvatore of international law firm BonelliErede highlights how the legal gap around the further utilization of data may be detrimental to some and advantageous to others.
How many notified bodies have been designated under the new EU Medical Device and IVD Regulations? Medtech Insight looks at the Nando database to monitor developments.