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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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Latest From Amanda Maxwell

The Cost And Complexity Of Implementing The EU Medical Device And IVD Regulations

Three experts talk about what it takes logistically for medtech businesses to prepare for timely compliance with the new EU Medical Device and IVD Regulations, and they spell out some of the challenges companies have encountered during a panel discussion at the recent LSX World Congress in London.

Medical Device Europe

Surprise As UK Notified Bodies Lose Major Part Of Their UK Role In Devices From March 29

There is now even more urgency for medtech companies, including small firms, to employ the services of EU27 notified bodies  with UK notified bodies set to have their conformity assessment roles temporarily withdrawn if the UK leaves on March 29 without a deal.

Medical Device Europe

To What Extent Are UK Medtech’s Ties With Rest Of World In Jeopardy Beginning March 29?

It is not only the UK trading relationship with the EU that could be interrupted after post-Brexit; relationships with countries with whom it enjoys mutual recognition agreements currently via the EU are also in jeopardy. How much progress has been made? And what happens next?

Medical Device Europe

EU Issues Brief Technical Update On UDI-DI Code Presentation

There has been a recent update related to how Unique Device Identification (UDI) will be applied to medical devices in the EU. It limits the number of characters that are used in a code and provides a check digit.

Medical Device Europe

BSI Touts 'Very Short' Waiting Times For Migrating Certificates From UK To Netherlands

With a growing urgency for medtech manufacturers to take decisive action so their products are not banned from the market under an increasingly likely no-deal Brexit, clients of BSI will be relieved to hear their notified body believes time is on their side.

Medical Device Europe

'UKCA Mark' To Replace CE Marking In UK Now, Or Eventually?

A new general UK safety mark, the UKCA, is being introduced to replace the CE mark in the event of a no-deal Brexit. How does this fit withthe  latest promise for UK to continue accepting CE marks for medtech?

Medical Device Brexit
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