Updates

We have assisted a diagnostics company with its companion diagnostics strategy, including the regulatory implications of combining diagnostic and therapeutic products.

We have advised a laboratory on the regulatory status of laboratory developed tests (LDTs) under the IVDR.

We have assisted a digital health company with its market access and reimbursement strategy for a remote patient monitoring solution in the Netherlands, including advising on the applicable reimbursement pathways and applicable healthcare legislation.

We have advised a telehealth provider on its data processing strategy in connection with the roll-out of a new digital platform, including advising on cross-border data exchange requirements for the provision of digital healthcare services.

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

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 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 advised numerous manufacturers on MDR and IVDR compliance, including guiding a small medical device company through the conformity assessment procedure with its notified body.