Updates

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 advised a client on collaborations between pharmaceutical companies and healthcare providers and contract research organisations, including the negotiation of framework agreements for clinical research.

We have assisted a pharmaceutical company with the alignment of its promotional materials with applicable codes of conduct.

We have assisted a large company in setting up a patient support program.

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.

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

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

We have advised on commercial contracting and borderline classification cases.