Erik Vollebregt
Partner and attorney-at-law
Erik is one of the founding partners of Axon Lawyers . As a lawyer and strategic advisor, he works with companies and investors across medical technology, pharmaceuticals, and biotech. He advises Member States, EU institutions, and industry associations on EU law development, represents clients before a range of courts including the European Court of Justice, the EU General Court and Dutch Administrative Supreme Court and advises on regulatory aspects and strategy in life sciences M&A transactions. He is particularly sought after for untangling the cumulative application of overlapping EU product regulatory frameworks — what the field has come to call the regulatory lasagna. In certain circles, CE has long been understood to mean Call Erik.
Erik holds a master’s degree in law from the University of Groningen and an LL.M. in European Law from Stockholm University. He is a regular speaker at international conferences and contributes actively to the policy debate on EU medical device and digital health regulation, including the ongoing revision of the MDR and IVDR. His work on the intersection of the AI Act, MDR, IVDR, and pharmaceutical legislation has made him one of the leading voices on regulatory convergence in the EU life sciences sector.
Analytically rigorous and direct, Erik brings both doctrinal depth and an instinct for lateral thinking to problems that resist conventional solutions. Clients value his ability to see across regulatory frameworks simultaneously and translate that into workable strategy to tackle complex legal and regulatory problems.
Outside the office, Erik is investor and board member of Raiana, a regulatory AI company. When he’s not working he can typically either be found on or in the water windsurfing, sailing, or diving or he’s cooking, reading or watching sci-fi with his cats.
Practice areas
Advertising and Claims
In sectors such as medical devices, cosmetics, food, feed, dietary supplements, and related products, the way you communicate about your products is subject to strict and ever-evolving regulations. Whether it concerns nutrition claims, health claims, environmental & sustainability claims, or beauty claims, what you say matters both commercially and legally. Getting it right builds consumer trust. Getting it wrong can lead to regulatory action and reputational damage.
Due Diligence
Before entering into a transaction or a collaboration with another party, it is essential to understand what you are dealing with. In life sciences, that is rarely straightforward. The value or risk of a counterparty is often concentrated in assets and arrangements that require specialist knowledge to assess properly: a regulatory approval that may be narrower in scope than it appears on paper, an IP portfolio with unresolved ownership questions, or supply chain arrangements that carry hidden compliance risks. Identifying these issues before you commit determines whether a deal or partnership delivers what you expect.
Litigation
Disputes in the life sciences sector arise in many forms: product liability claims, complaints, contractual breakdowns, regulatory enforcement actions, intellectual property conflicts, freedom of information procedures, or challenges to product authorisations. Whatever the nature of the dispute, effective litigation in this sector requires more than legal skill. It requires a thorough understanding of the technical and regulatory context in which the conflict arose, as that context often determines both the strength of the legal arguments and the practical outcome of a case.
Regulatory Compliance and Enforcement
Life sciences companies regularly find themselves on the receiving end of government action. Regulatory authorities such as the Dutch Health and Youth Care Inspectorate (IGJ), the Dutch Food Safety Authority (NVWA), the Dutch Data Protection Authority (AP), and the Netherlands Authority Consumers and Markets (ACM) have broad powers to investigate, sanction, and impose corrective measures. At the same time, companies may face freedom of information requests at governmental authorities or need to comply with other legal obligations that risk exposing confidential business data, or must navigate strict procurement rules when contracting with public institutions. In each of these situations, you are dealing with a government body that operates under its own legal framework, and you need a legal partner who knows both that framework and your sector inside out.
Spin-out and Starter Advisory
Spin-outs and life sciences starters sit at the crossroads of company formation, intellectual property, financing, and regulatory compliance. Whether you are a researcher spinning out a venture from a university or knowledge institute, or an entrepreneur launching a life sciences startup, the early decisions you make on corporate structure, IP-ownership, funding, and team incentives will shape the trajectory of your company for years to come. Getting these foundations right from day one is a necessity.
Related publications
We have assisted a manufacturer of medical devices in obtaining a derogation from conformity assessment procedures under the MDR in the interest of public health.
We have provided in-house training for the authorised representative of a large multinational on its obligations under the MDR.
We have advised a company on defending itself against an enforcement action brought by the Netherlands Food and Consumer Product Safety Authority (NVWA).