Updates

We have advised several clients, including Dutch Growth Funds, on the structuring and application of government funding and related public-private partnership schemes aimed at stimulating innovation in the life sciences and health sector. Our advice covers the design and structuring of funding schemes, including the formulation of eligibility criteria and subsidy conditions, the establishment of governance frameworks for public-private consortia, and the administrative and legal requirements for the disbursement of government-funded research and development grants.

We set up procedures for multiple clients continues transfers of personal data beyond the EU, including to countries without an adequate data protection regime, for various purposes.

We have conducted regulatory due diligence on behalf of a private equity firm in connection with the acquisition of a medical device manufacturer, covering MDR compliance (including notified body certificates and post-market surveillance obligations), as well as data protection aspects.

On behalf of a medical device company, we reported a personal data breach to the supervisory authority and have advised on internal communication.

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.

For a client conducting a multinational clinical investigation, we have drafted informed consent notices that allow for long term use of clinical research data beyond the confines of the study.

We have trained the entire regulatory team of a medical device company on understanding GDPR compliance in a clinical research setting.

We have created the data protection strategy for a long-term registry study.

We have advised a medical device manufacturer on collaborations with academic institutions on data collection for training of AI systems, including the necessary data protection contracts.

We have assisted a medical device manufacturer in ensuring that their SAAS-application complies with the Data Act and the GDPR.