Amanda Maxwell
European Regulatory Affairs Editor
European Regulatory Affairs Editor
UK
+37 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
EU rapidly revises new guidance document on registration requirements under the new MDR and IVDR to address question of when importers need to register in Eudamed medical device database.
Medtech Insight: 世界の医療機器・医療技術の最新情報
Industry wants to see the number of products for which electronic IFU are permitted to be expanded. But there is a strong lobby pushing for paper IFU to still be made available.
Medtech Insight: 世界の医療機器・医療技術の最新情報
At last, the EU has reached its milestone of having 20 notified bodies designated under the Medical Device Regulation. And Finland now boasts two.
Medtech Insight: 世界の医療機器・医療技術の最新情報
There has been quite a lot of conjecture over whether UK notified bodies would have to cease their CE marking operations on Brexit day, 31 January, or whether they would be able to continue until the end of the EU/UK withdrawal agreement. BSI's Gary Slack explains that BSI, for one, is still open for business.
Medtech Insight: 世界の医療機器・医療技術の最新情報
The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to all medtech manufacturers with CE marked medical devices from 1 December
Medtech Insight: 世界の医療機器・医療技術の最新情報
Switzerland’s current economic and trading relationship with the UK is based on its MRA with the EU. So, where does this leave the two countries in trading with one another now each of their relationships with the EU are under threat?
Medtech Insight: 世界の医療機器・医療技術の最新情報
There may have been a significant increase in the amount of regulatory activity at EU level of late, but the medtech industry remains alarmed at the lack of readiness of the system, and calls for an urgent focus on IVDs now too.
Medtech Insight: 世界の医療機器・医療技術の最新情報
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
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
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
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
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
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
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
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?
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