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 first certificates have now been granted to medical device-manufacturers under the EU’s new regulations coming into force next year. Is this a sign that the whole sector is going to be on time to meet the requirements of the new Regulations? Or is it already too late?
Once the MDR is in force, current standards harmonized under the Medical Device Directive cannot be used to claim a presumption of conformity with specific requirements under the new Regulation. But updating these standards so they are harmonized under the MDR has hit a roadblock.
Another new era is approaching for medtech as the European Commission decides that oversight of this economic sector should reside among those with an interest in health matters. Will much change?
EU notified bodies are still hiring staff rapidly to manage the enormous workload as the deadline for the Medical Device Regulation looms in just nine months. Elena Kyria explained what is driving notified body-related recruitment moves and what to expect.
If you are finding it difficult to follow what is happening on the broad political level in the UK as well as on the technical medtech level, you are not alone. Here we explain why Brexit-related dates are up in the air for the UK.
The UK government has set 1 November 2019 as the date the UK’s own medtech regulations will apply, the day after the country is, in theory, due to leave the EU and potentially without a deal. But nothing is certain on the UK political scene any longer, not even this.