Updates

Axon assisted a cosmetics company facing enforcement by the Dutch Food and Consumer Product Authority NVWA re. the sample service it operated. Axon advised the company on the applicable CPNP notification and labelling requirements, based on which the company could ensure compliance.

Axon assisted a start-up developing a real-time diagnostic test to define pathogens food. We negotiated and drafted an agreement with a university to support the further development & validation of the technology.

We have advised a large pharmaceutical company on the conduct of combined studies in collaboration with IVD manufacturers.

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

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

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

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 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.

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