Updates

We have advised a start-up on enforcement actions brought by the Dutch Healthcare Inspectorate (IGJ) concerning MDR compliance.

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 French VC company investing in a food tech start-up. We reviewed the target’s regulatory strategy under the EU novel foods framework, assessed its feasibility and outlined potential risks and how to mitigate these.

Axon helped The Protein Brewery rename its novel food product. We proposed consumer-friendly alternatives to the European Commission, resulting in an approved name the client is very happy with.

Our team has trained several multinationals on the implications of the Battery Regulation and the Packaging & Packaging Waste regulation, and regularly advises on these topics.

We have advised a client on an inspection by the Dutch Healthcare Inspectorate (IGJ).

We have advised a medical device manufacturer on the qualification and classification of a borderline product, including the determination of the correct regulatory pathway under the MDR and the mitigation of associated compliance risks.

We have conducted regulatory due diligence in connection with the acquisition of a pharmacy, covering compliance with applicable pharmaceutical and healthcare legislation.

We have conducted regulatory due diligence on behalf of a private equity firm in connection with the acquisition of a medical device manufacturer, covering MDR compliance (including notified body certificates and post-market surveillance obligations), as well as data protection aspects.

We have advised a mid-size company on extended producer responsibilities under environmental legislation.