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.

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

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

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.

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 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 provided in-house training for the regulatory and quality teams of several large MedTech companies.