Updates

We have assisted a client in setting up a multinational data strategy, including advice on anonymisation of personal data and interaction product regulations and the upcoming high-risk regime under the European Health Data Space Act (EHDS Act) to help them continue innovating without endangering company confidential developments.

We have advised a client on an inspection by the Dutch Healthcare Inspectorate (IGJ).

We have advised a medical device manufacturer on the qualification and classification of a borderline product, including the determination of the correct regulatory pathway under the MDR and the mitigation of associated compliance risks.

We have assisted several clients in challenging tender decisions by Dutch hospitals.

Our firm is experienced in the conduct and defence of companies against freedom of information cases pertaining to confidential under Dutch and EU law, and has defended a number of companies, including a multinational, in a series of such cases over the years.

One of our lawyers has acted as arbiter in international proceedings on MDR compliance.

Our firm litigates before the European Court of Justice on a variety of life sciences topics.

We have advised several clients on legacy status and the impact of the targeted revision of the MDR and IVDR.

We have worked with a multinational medical device company to ensure compliance of its advertising materials with local advertising and promotion rules in the Netherlands.

We have advised a medical device company on its proposed advertising strategy covering social media channels prior to the roll-out of a new product line in the Netherlands.