Updates

The PFAS proposal: what is it, and where does it stand?

EU law increasingly regulates the use of PFAS, the so-called "forever chemicals". For MedTech and pharma companies, the implications are significant and some restrictions already apply.

Our team has trained several multinationals on the implications of the Battery Regulation and the Packaging & Packaging Waste regulation, and regularly advises on these topics.

We have advised several clients on the classification of their medical devices, including software products, under the MDR and IVDR, and have helped them in negotiating.

Our team advised a client on the registration process under REACH.

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

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

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 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 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.