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 UK is taking measures to increase its ventilator stock from 8,000 to some 30,000, but it will take time to make them available. Many are asking whether the government really rejected EU help, which could have brought relief sooner, because of Brexit.
How to get non-CE-marked medical devices onto the UK market at speed
Manufacturers normally must pay to access medtech and personal protective equipment standards. But now some are freely available in the EU.
At last there is news from the Commission that it is responding to the growing pressure to delay the implementation of the EU Medical Device Regulation. It looks like there will be a one-year reprieve. But uncertainty remains.
The slow designation of notified bodies under the IVD Regulation is likely to mean that the IVD industry will face hurdles due to lack of timely availability of these resources when demand rises exponentially.
For the first time, the EU medtech industry has called on the European institutions to postpone implementation of the Medical Device Regulation and the IVD Regulation until the COVID-19 crisis is over.