Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

Advertisement
Set Alert for Articles By Amanda Maxwell

Latest From Amanda Maxwell

IVDR Notified Body Numbers – Has Enough Progress Been Made?

Will there be enough resources for IVD manufacturers to be audited in time against the EU's IVD Regulation? A survey from TEAM-NB reveals a drop in notified body numbers just at a time when more resources are needed.

Medical Device Europe

Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations

Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified bodies are the biggest barrier to products being able to comply with the new EU Medical Device Regulation before deadlines. Time is running out.

Europe Medical Device

UK To Demand 'Responsible Person' Be Physically Located In Country Under No-Deal Brexit

The recent no-deal Brexit notice from the UK government says that companies selling devices in the UK would need a "Responsible Person" in the UK if the firm is not based there. The government clarifies to Medtech Insight that such person must be physically present in the UK, and not simply have an address there.

Brexit Europe

EU Regulatory Roundup, 2018: Year Of Dithering And Distractions Likely To Be Topped By Upcoming Year Of Turbulence And Stress

2018 needed to be medtech's year to focus on the ongoing implementation of the EU MDR and the IVDR and the structures and documents to support them.  But lack of progress means a 2019 work bulge amid Brexit issues and recent journalistic investigations. Here's a look at the top EU regulation issues and articles of the past year.

Europe Regulation

Brexit At The 11th Hour: UK Refreshes No-Deal Guidance For Medtech

With the UK still wallowing in uncertainty over Brexit, the government has been forced hit the ground running in January by issuing various documents spelling out in greater detail what will need to happen in the case of a "no-deal" Brexit, which is looking increasingly possible. What does medtech need to know?

United Kingdom Brexit

EU Regulatory Roundup, December 2018: Renewed Focus On Regs While 'Implant Files' Still Grabs Attention

Passing the half-way mark in the transition period to full implementation of the EU's new Medical Device Regulation (MDR) seems to have focused the attention of readers back onto technical regulatory issues.

EU Policy & Regulation
See All
Advertisement
UsernamePublicRestriction

Register