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European Regulatory Affairs Editor
UK
39+ years of 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
By Amanda Maxwell 14 Sep 2021
Gone are the days when notified bodies needed to promote themselves to gain business. Now industry is left struggling to find services ̶ and the EU regulatory outlook is becoming worrisome.
Medtech Insight
By Amanda Maxwell 13 Aug 2021
Ensuring key standards are available for manufacturers to demonstrate compliance with the MDR and IVDR is one of the top priorities for the European Commission after the summer break.
Medtech Insight
By Amanda Maxwell 13 Jul 2021
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
By Amanda Maxwell 16 Jun 2021
With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.
Medtech Insight
By Amanda Maxwell 08 Jun 2021
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
By Amanda Maxwell 07 Apr 2021
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
By Amanda Maxwell 27 Nov 2020
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
By Amanda Maxwell 29 Oct 2020
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
By Amanda Maxwell 21 Oct 2020
Is the current pandemic too big a hurdle for the EU’s medtech regulators and industry alike? What else might hold EU medtech back from the successful implementation of the MDR?
Topic EU Policy & Regulation
Medtech Insight
By Amanda Maxwell 25 Aug 2020
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
By Amanda Maxwell 18 Mar 2020
The UK is near the bottom of the European ranking of ICU beds available, with just 6.6 per 100,000 – and it has just 5,000 ventilators. The COVID-19 crisis is demanding a response that many are comparing to a war effort.
Topic Coronavirus
Medtech Insight
By Amanda Maxwell 27 Jan 2020
Erik Hansson remains deputy head of devices in a move to the European Commission’s DG Sante from DG Grow. He now answers to a newly appointed devices head who shares a common educational background but whose recent pharmaceutical role may unsettle the devices industry.
Topic EU Regulation
Medtech Insight
By Amanda Maxwell 18 Dec 2019
Medtech industry gets best seasonal gift as Council of EU and European Parliament agree on longer transition period for upclassified Class I medical devices. But how many notified bodies are still auditing products under the medical device directives?
Topic EU Regulation
Medtech Insight
By Amanda Maxwell 11 Dec 2019
Only just over a month ago there were fears that the implementation of the EU Medical Device Regulation was going to be hampered by a lack of expert panel applicants. Now it seems there is no shortage. The news raises lots of questions about when and how the structure will now work.
Medtech Insight
By Amanda Maxwell 06 Dec 2019
The two-year delay to Eudamed was a Commission decision. Now the competent authorities are fighting back and the issue is to be discussed at the level of the Council of the European Union on December 9 to avoid “heavily burdensome administrative transitional solutions.”
Medtech Insight
26 Jul 2022
Medtech Insight
21 Jul 2022
Medtech Insight
21 Jul 2022
Medtech Insight
14 Jul 2022
Medtech Insight
14 Jul 2022
Medtech Insight
07 Jul 2022
Medtech Insight
05 Jul 2022
Medtech Insight
05 Jul 2022
Medtech Insight
01 Jul 2022
Medtech Insight
30 Jun 2022
Medtech Insight
28 Jun 2022
Medtech Insight
27 Jun 2022
Medtech Insight
17 Jun 2022
Medtech Insight
14 Jun 2022
Medtech Insight
13 Jun 2022
