Amanda Maxwell
European Regulatory Affairs Editor
European Regulatory Affairs Editor
UK
+35 year(s) experience
Amanda closely monitors the implementation of the Medical Device and IVD Regulations and the challenges that the sector is encountering is being in compliance in time. In so doing, she keeps in constant communication with a broad base of expert contacts around Europe. Moreover, as the UK heads for Brexit, she monitors the likely impact of political developments on the medtech sector.
Amanda also has experience in providing medtech regulatory strategy consultancy services, and is a frequently invited speaker and chair at EU meetings on medtech regulations and drug/device combination regulatory issues.
Medtech Insight: 世界の医療機器・医療技術の最新情報
03 Jul 2019
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.
Topic brexit
Medtech Insight: 世界の医療機器・医療技術の最新情報
02 Jul 2019
The UK government is introducing new registration requirements for medical devices in the event of a no-deal Brexit. They will be rolled out according to the risk class of products. But some fundamental questions have arisen.
Medtech Insight: 世界の医療機器・医療技術の最新情報
11 Jun 2019
There had been warnings that the first notified bodies would not be designated by the European Commission until late July 2019, 10 months before the full application of the EU Medical Device Regulation. But now that BSI is the first notified body in the EU to be designated under the MDR, are things looking up?
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Amanda Maxwell 22 Feb 2019
Efforts are underway by EU notified body groups to encourage a uniform interpretation of the EU MDR when it comes to the risk classification of spinal implants. Their work could also reduce the amount of unnecessary notified body and expert panel work on some implantable devices.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
07 Feb 2019
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.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Amanda Maxwell 22 Aug 2018
Belgium is introducing new registration requirements for medical device and IVD operators June 17, ahead of the full application of the EU's medtech regulations and new Eudamed medical device database.
Topic business-strategies
Medtech Insight: 世界の医療機器・医療技術の最新情報
22 Aug 2018
The new EU Medical Device Regulation offers companies an option to market CE-marked devices for an extra four years under current directives. But more hurdles are being identified that make this option less attractive.
Topic Brexit Business strategies
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Amanda Maxwell 06 Jul 2018
UK starts to discuss emergency measures around devices as no-deal Brexit concerns mount. But it is still looking like the UK will continue to implement the Medical Device Regulation, in the short-term at least. Will it be a different matter for the IVD Regulation?
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Amanda Maxwell 04 Dec 2017
The EU body that will drive implementation of the new Medical Device and IVD Regulations
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Amanda Maxwell 14 Nov 2017
The EU Roadmap has been published. But it represents a dawning of a hard truth.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Amanda Maxwell 10 Oct 2017
While UK medtech is absorbed by uncertainties caused by Brexit and the new EU regulations, it is being eyed by the US, which sees opportunities.
Topic Brexit
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Amanda Maxwell 18 Sep 2017
If there is a delay in appointing EU notified bodies under the new Medical Device and IVD Regulations.
Medtech Insight: 世界の医療機器・医療技術の最新情報
23 Mar 2017
How can you be sure that your notified body is operating fairly and to a high standard? How long can your products remain on the market if your notified body’s operations are suspended or simply cease? Chapter IV of the forthcoming Medical Device and IVD Regulations details requirements for notified bodies as well as the process for their designation and monitoring.
Medtech Insight: 世界の医療機器・医療技術の最新情報
17 Jan 2017
2017 is going to be a pivotal year for EU medtech regulations. We are expecting the new Medical Devices Regulation and IVD Regulation to take effect. But there are some big concerns and uncertainties at the center of it all.
Topic Policy and regulation Medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
24 Nov 2016
The EU’s joint action on market surveillance, now a focus after the success of the joint action on notified bodies, is focusing on cooperation and avoiding duplication, rather than a step change, to achieve a safe EU.
Topic policy-and-regulation
Medtech Insight: 世界の...
12 Nov 2019
Medtech Insight: 世界の...
01 Nov 2019
Medtech Insight: 世界の...
29 Oct 2019
Medtech Insight: 世界の...
25 Oct 2019
Medtech Insight: 世界の...
10 Oct 2019
Medtech Insight: 世界の...
04 Oct 2019
Medtech Insight: 世界の...
03 Oct 2019
Medtech Insight: 世界の...
19 Sep 2019
Medtech Insight: 世界の...
06 Sep 2019
Medtech Insight: 世界の...
04 Sep 2019
Medtech Insight: 世界の...
03 Sep 2019
Medtech Insight: 世界の...
03 Sep 2019
Medtech Insight: 世界の...
28 Aug 2019
Medtech Insight: 世界の...
21 Aug 2019
Medtech Insight: 世界の...
20 Aug 2019