Updates

We have provided in-house training for the regulatory and quality teams of several large MedTech companies.

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 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 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.

Our team assisted a mid-sized cosmetics company with the negotiation of a distribution agreement.

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.