Updates

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.

We have assisted multiple manufacturers with the transition of their legacy IVD Directive products to the IVDR framework.

Axon acted on behalf of an investor in connection with their investment in a clinical-stage biotech company developing first-in-class therapeutics and diagnostics for fibrosis. We conducted legal due diligence on the target company and reviewed the transaction documentation on behalf of the investors.

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