We have assisted multiple manufacturers with the transition of their legacy IVD Directive products to the IVDR framework.
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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 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.
Our team advised a client on the registration process under REACH.
Axon acted on behalf of an investor in connection with their investment in a clinical-stage biotech company developing first-in-class therapeutics and diagnostics for fibrosis. We conducted legal due diligence on the target company and reviewed the transaction documentation on behalf of the investors.
Axon assisted a Dutch IVD company in securing a EUR 24M equity financing round, advising on the transaction structure, investment documentation and related matters.