Updates

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

We have advised a healthcare provider on compliance with the Dutch Healthcare Quality, Complaints and Disputes Act (Wkkgz), including the implementation of an internal complaints procedure and the appointment of a complaints officer.

We have advised a healthcare institution on the conditions under which medical professional secrecy may be breached.

We have advised a large MedTech company on the structuring of its collaboration with Dutch healthcare providers and healthcare professionals for clinical research and product development purposes.

We have assisted a healthcare start-up with the regulatory requirements for establishing a healthcare institution in the Netherlands, including the required permits and governance structure.

We have assisted a medical device manufacturer in assessing whether its product is eligible for reimbursement under Dutch healthcare insurance law.

We have advised a digital health start-up on the qualification of its services under Dutch healthcare law, including the determination of whether the company qualifies as a healthcare provider and the resulting regulatory obligations.

We have assisted a distributor of medical devices on questions pertaining to a cleaning solution regulated under the Biocidal Product Regulation.

We have advised a medical device manufacturer on the regulatory implications of the restriction on synthetic polymer microparticles for its products.

We have advised a start-up on the legal limitations and requirements related to the transport of dangerous substances.