Erik Vollebregt

Erik Vollebregt

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.

Medical technology regulation
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.
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 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. I am however constantly baffled by the fact that no one ever considers that this type of software, which has either an important role within a medical process or has a medical function in itself (treatment or diagnosis), should be validated on another level than the purely functional one (the “does it work?” level). This seems to be part of a bigger problem, because physicians have recently repeatedly demonstrated that they are not that familiar with medical technology rules (but still criticise them). A case in point is the recently launched online “Health risk test” from the Dutch Bronovo hospital. For a mere € 19,95 (for the expert test, there’s a free version too) you can fill in a host of information about your yourself, your medical history and your lifestyle after which you receive back an overview outlining a number of highly prevalent diseases and the risk of you contracting them. A lot of doctors seem to have cooperated on this software and have lent their name to it, given the number of pictures of people in white coats on the website. In my view, we are talking about a medical device here: there is a piece of software running on a server which applies a model or decision tree, the software produces a result based on this decision tree, the application serves up the information for medical purposes (diagnosis of health risks). In other words, the application fits the definition of software as...