Updates

We act as regulatory counsel to authorised representatives of non-EU manufacturers.

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 legacy status and the impact of the targeted revision of the MDR and IVDR.

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

We have advised on commercial contracting and borderline classification cases.

We have advised an importers, distributors on a complex international supply chain strategy under the MDR.

We have advised several clients on the classification of their medical devices, including software products, under the MDR and IVDR, and have helped them in negotiating.

We regularly advise start-ups and large scale manufacturers on clinical evaluation and clinical investigation requirements. We have assisted a start-up with have supported a mid-sized medical device company in preparing its clinical evaluation report for a high-risk device.