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Borderline Clinical investigation Software eHealth M&A

Presentations Medical Software & Apps Seminar

Axon Medical Software & Apps

Presentations can be downloaded by clicking on the titles:

Pre-Market Authorization And Other Sweeping Proposals Unveiled In EU Parliament

High-risk medical devices would for the first time be subject to a government pre-market authorization process read more

Regulation chart medical devices

This chart provides a non limitative overview of EU legislation relevant to medical devices manufacturers. The chart is presented at the RAPS Chapter Netherlands-Flanders meeting on 26 April 2013. It is a practical tool for determining which legislation applies to certain medical devices. Hyperlinks to the full text of legislation, legislative summaries and background information are included in the chart.

Genieten met zorg voor je gezondheid dankzij betere vetten en vezelrijke voeding

Kort commentaar bij en samenvatting van College van Beroep RCC 11 april 2013

Claims: EU wettelijk kader

Om voedings- en gezondheidsclaims is veel te doen geweest sinds het vaststellen van EG Verordening 1924/2006 inzake voedings- en gezondheidsclaims voor levensmiddelen lees meer

Presentations Corporate Law Seminar

Axon Seminar Corporate Law

Presentations can be downloaded by clicking on the titles:
New Dutch company law, Introduction of the Flex BV by Ernst Rozelaar, Schut Van Os Civil Notaries
Venture Capital & Corporate Governance in practice by Harrold van Barlingen, Thuja Capital
One tier board and conflict of interest by Carine van den Brink, Axon Lawyers

European Regulation Looms Over Mobile Health

The mHealth Regulatory Coalition, an industry group that has been active in engaging FDA on evolving mobile health policies, is now extending its efforts to Europe as the European Union and several member countries are planning new regulations read more

Presentations Novel Foods & Health Claims Seminar

Axon Seminar Novel Foods & Health Claims

Presentations can be downloaded by clicking on the titles:
Future of Food by Roger van Hoesel, Food Valley and StartLife
Legal & regulatory aspects of Novel Foods & Health Claims by Karin Verzijden, Axon Lawyers
Challenges to bring innovative ingredients to market by Henk Aalten, DSM

Medische Apps niet zonder gevaar

Het toenemend gebruik van medische apps door zorgprofessionals kan de patiëntenzorg verbeteren, maar heeft ook potentiële gevaren. Regels en protocollen ontbreken nog. Lees meer
 

Axon Seminar Medical Devices

Wednesday 14 November Medical Devices Seminar

Axon organizes a seminar addressing the new medical devices proposal
Program and invitation

How easily digestible wine and healthy chocolate tempt to seduce

Recent decisions on Health Claims

By 14 December 2012, food items in the European Union (EU) with a health claim on their packaging read more

EC proposes new Clinical Trial Regulation

EC proposes new Clinical Trial Regulation

Clinical trials are investigations of medicines in humans where the medicines are applied to outside normal clinical practice on the basis of a research protocol. They are essential for the development of new medicines of which inter alia safety and efficacy need to be established. read more

EFSA update on cloning in relation to food production

Cloning for food production:pros and cons

The use of cloned animals for food production is highly controversial. On the one hand, cloning could contribute to the faster breeding of farmed animals that show improved parameters on resistance read more

Op de opiniepagina van het FD van 22 juni jl.

Flink aantal medische apps is 'illegaal'

Een flink aantal medische apps, kleine computerprogramma's voor telefoon of tabletcomputer, is illegaal. lees meer

There's an app for that: CE-certificering van medische hulpmiddelen

Inleiding

Er komt meer en meer software op de markt die in een klinische setting wordt gebruikt. Tot voor kort vond met medische software in klinische setting vooral op PACS-systemen, op netwerken lees meer

Artikel in Medische Technologie over reparatie medische apparatuur door Erik

Reparatie medische apparatuur

Nu ziekenhuisbudgetten meer en meer onder druk komen te staan, merk ik in mijn praktijk dat ziekenhuizen meer uitwijken naar andere partijen dan de OEM voor reparaties die na verloop van de garantietijd moeten plaatsvinden. lees meer

Erik interviewed for Quality World on implants

Implanting Quality and rooting out risk

First it was burst breast implants and then disintegrating hipimplants. After making headlines around the world, finger-pointing ensued, with both regulatory authorities and manufacturers coming under read more

Eudamed - strengthening EU medical device surveillance and the issues ahead

Netherlands-based medical devices legal specialist Erik Vollebregt speaks to Ashley Yeo about how the European database of medical devices is faring. The European database of medical devices, Eudamed, is showing its potential to strengthen market surveillance and transparency by providing, in one place, clinical and vigilance data on devices in circulation.

Interview Scrip Regulatory Affairs with Erik about European medical devices vigilance and PIP scandal

Netherlands-based medical devices legal specialist Erik Vollebregt speaks to Ashley Yeo about how the European database of medical devices is faring.

The European database of medical devices,Eudamed, is showing its potential to strengthen market surveillance and transparency by providing, in one place, clinical and vigilance data on devices in circulation in the EU. Further improvements may be warranted, but there are bigger issues ahead for what

Mobile medical apps guidance: what's good for the US is good for the EU


Bradley Merrill Thompson and Erik Vollebregt argue in the October issue of Scrip Regulatory Affairs that draft guidance from the US Food and Drug Administration on mobile medical applications could apply in the EU too.
On 21 July, the US Food and Drug Administration released draft guidance on mobile medical applications, a document we think has great significance for the regulation of EU eHealth and medical device markets, even while in draft form.

EU court to clarify medical device / drug borderline and the status of MEDDEV documents

Important developments for the medical devices and medicinal products industry: clarification of EU law about the borderline between these groups of products is currently in the making at the European Court of Justice.

Some important practical points for ISO 14155 compliant clinical trial agreements in the EU, part 2

In a previous post I gave a number of practical tips for drafting ISO 14155 clinical trial agreements. In this post I will give another few. Additional points will surely come to mind and if so, I will devote a next post to those.

New EU Commission guidance on medical devices borderline products and classification

Yesterday the European Commission’s Working Group on Borderline and Classification issued the new version (1.10) of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. This manual has been around for some years and is gradually amended and updated from time to time.

Some important practical points for ISO 14155 compliant clinical trial agreements in the EU, part 1

In my day-to-day legal practice I see a number of points related to clinical investigation that seem to return and repeat all the time and thought it a good idea to share my thoughts on these. This list is not exhaustive and just a start (it will be extended in future postings), but it will give you some important pointers to avoid commonly made mistakes that can be costly to fix, may cause your sales to collapse and/or lead to investigation by the authorities. Of course all these point are intended to lead to ISO 14155 compliant agreements.

FDA draft guidance on mobile medical applications

On 21 July the FDA released Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications, a document that I think has great significance for the regulation of the EU eHealth and medical device markets, even if it is presently only a draft. If adopted by the FDA its importance will only increase. You can download a copy of the document with my annotations in it over here.

Consequences of the EU Ker-Optika case for eHealth services

In a previous post I have analysed the consequences of the European Court of Justice's Ker-Optika judgment for e-commerce in physical medical devices. This post extrapolates the reasoning of the European Court in that case with respect to the provision or sale of medical devices as services in the context of eHealth services. My conclusion is that eHealth services constituting medical devices are regulated identically under EU law to physical medical devices and analyses the consequences of this.