Updates

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

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.

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

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 advised a mid-sized company on the qualification of a cosmetic product to facilitate its compliant and effective market launch.

Our team negotiated a cooperation agreement between a cosmetics brand owner and a manufacturer on behalf of a mid-sized company.

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

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.

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