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 current European Commission medtech working group structure has evolved over the last 25 years. Now some changes are needed.
"I fail to see any merit in this piece of dismally bad legislation. It is absolutely in no one’s interest," says consultant and regulatory expert Jaap Laufer, who predicts disastrous impact on many companies and the end of notified bodies as we know them.
It's been a long and painful journey, but some progress has finally been made in Brexit talks. It is looking hopeful now that a "hard Brexit," or no-deal Brexit, is unlikely. Is there more good news coming for devices?
The EMA does not just regulate drugs. It plays a vital role with some drug/device combination products and borderline products. Just as that role is expanding, relocation threatens to cause a hiatus for device-type products.
There are a growing number of conflicting opinions about what Brexit is going to mean to the EU medtech sector. Confusion seemed to grow throughout November, just when clarity is urgently needed. So, where are things heading?
The increasingly challenging environment that EU notified bodies find themselves operating in is translating into some real headaches for device and diagnostics manufacturers. Here, three top EU medtech regulatory experts spell out the challenges.