Updates

We have advised on commercial contracting and borderline classification cases.

We act as regulatory counsel to authorised representatives of non-EU manufacturers.

We have advised an importers, distributors on a complex international supply chain strategy under the MDR.

We regularly advise start-ups and large scale manufacturers on clinical evaluation and clinical investigation requirements. We have assisted a start-up with have supported a mid-sized medical device company in preparing its clinical evaluation report for a high-risk device.

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.

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

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 distributor of medical devices on questions pertaining to a cleaning solution regulated under the Biocidal Product Regulation.

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