Updates

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 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 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 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 start-up on the regulatory qualification and classification of its health application under the MDR, including the determination of whether the software qualifies as a medical device or as a wellness product.

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

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

We have advised an IVD manufacturer on a bringing companion diagnostic to market with respect to a patient support program.

Our team has advised an IVD-manufacturer on use of the inhouse-exemption under the IVDR.

We have advised pharmacies on the regulatory aspects of pharmaceutical compounding.