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Karin Verzijden
Shock and awe: they did it! A few days after the United Kingdom voted to leave the European Union, many sectors are investigating the consequences thereof for the services and products concerned….
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Erik Vollebregt
Lack of progress on medical device reform legislation has spurred some EU countries to use last year’s joint immediate action plan to improve device oversight. Regulators using the joint plan will stay…
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Erik Vollebregt
The EU ombudsman is urging the European Commission to reexamine allegations that Greek hospitals violated procurement laws to favor certain suppliers, saying the country has a history of flouting the law. The…
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Erik Vollebregt
The UK Medicines and Healthcare products Regulatory Agency has issued guidance on how medical devices manufacturers can provide an electronic format of their instructions for use (eIFU). However, the guidance has come…
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Karin Verzijden
This seminar focussed on the food information and nutrition and health claims regulations. Speakers and their presentations: Bernd Mussler, DSM Marketing ingredients supported by EU Health claims Karin Verzijden & Sofie van…
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Carine van den Brink
If you are active in the medical software field in the Netherlands you may probably be aware already that the the Dutch healthcare Inspectorate IGZ has announced that it will rigorously enforce…
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Erik Vollebregt
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.
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Erik Vollebregt
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…