Updates

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

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.

What distinguishes our lawyers is the ability to see the whole regulatory picture. We have assisted multiple clients, ranging from CROs to pharma start-ups to medical device manufacturers, in setting up GDPR compliance processes and agreements that allow for seamless interaction with other legal frameworks such as MDR and IVDR.

We have advised several clients on the conduct and defence of complaints made to the Dutch Advertising Committee regarding claims about products such as foods, pharmaceuticals and medical devices across Dutch media.

We have advised a medical device manufacturer on compliance with the Dutch Medical Device Advertising Code of Conduct in connection with the launch of a promotional campaign for a new medical device.

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.

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.