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 manufacturers, distributors and authorised representatives on all aspects of the IVDR, including assisting a diagnostics manufacturer with the classification and conformity assessment of its in vitro diagnostic medical devices under the new IVDR framework.

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 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 guided several clients through notified body interactions and discussions with competent authorities on product classification.

We have supported an IVD manufacturer in the design and conduct of performance studies. We regularly advise clients on post-market performance follow-up (PMPF) obligations.