Erik Vollebregt
Life Sciences and IP Lawyer, and Founding Partner Axon Lawyers
Erik is a lawyer specialised in EU legal issues relating to medical devices. He has wide experience in life sciences legislation and regulatory, at EU and Dutch level. Erik was trained as intellectual property and competition lawyer. He has gained experience in contentious matters, commercial contracts, and transactional work at the Directorate-General for Competition of the European Commission. He also worked for three large international law firms.
Erik worked and lived in Brussels for several years, and is fluent in Dutch, English, French, German, and Swedish. Erik is acknowledged by Chambers Europe for his work in the field of intellectual property and life sciences.
Erik’s software and engineering family background urged him to specialise in regulatory intellectual property and legal work in the medical technology industry. His clients range from the largest listed to the smallest startup companies.
Erik is a prolific writer and publishes in life sciences legal and regulatory journals on a wide variety of subjects. He is an editor of the Dutch life sciences law and regulatory journals Jurisprudentie Geneesmiddelenrecht and JGR Plus, as well as and author of a Dutch handbook on misleading and comparative advertising law Oneerlijke handelspraktijken, misleidende reclame en vergelijkende reclame. Additionally, he has a weblog on legal and regulatory aspects of medical technology, Medicaldeviceslegal. Erik is further authoring several medical technology chapters of RAPS’ EU Fundamentals of Regulatory Affairs. He often lectures at (inter)national conferences and is a guest lecturer on pharmaceutical law, medical technology law and advertising law at the universities of Groningen and Twente.
As additional external activity Erik is president of the NEN (Dutch Standardisation Institute) Platform on Software and Medical Devices.
His memberships include the Netherlands Biotech Industry Association (NIABA), the Dutch Association Pharmacy and Law (VFenR), the Dutch Association for Healthcare Law (Vereniging voor Gezondheidsrecht), the Dutch Association for Advertising Law (VvRr), and Regulatory Affairs Professional Society (RAPS)
Erik is also a cyclist, long distance runner, scuba diver, and Apple user.
3 blogs from the author
Posted on 17.01.2013
The proposed scrutiny procedure: a measure proven to be ineffective in the world of pharma regulations
If there is one thing that the medical devices industry agrees on it is that the new proposals for medical devices and IVD regulations are welcome and necessary evolution of regulation. What the industry also agrees on is that although it generally supports the new proposals, it is not certain at all that the proposed scrutiny procedure will achieve the intended goals.
Posted on 12.04.2012
Standalone software: objects in the regulatory mirror may appear simpler than they are
January 2012 was a fruitful month for EU guidance on medical devices and produced among other MEDDEVs the MEDDEV 2.1/6 Qualification and Classification of stand alone software. This MEDDEV contains the latest thinking on how stand alone software, i.e. software that does not necessarily run on a medical device (but may have medical device functionality), qualifies as medical device under the three medical devices directives. If you are interested in a lot more background about the MEDDEV than I can provide in this blogpost (and especially nice flowcharts, which make life more simple for everyone), you can find it here.
eHealth applications and websites developed by clinicians: there are rules for that!
eHealth is booming, hospitals, doctors, clinics, SMEs, big companies, everybody seems to be developing an app nowadays. It is great to see how many people are throwing their weight behind eHealth initiatives in every possible way: remote monitoring of demented senior citizens by means of image interpreting software, decision support systems, …, you name it. […]
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