Updates

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

We have advised a company on defending itself against an enforcement action brought by the Netherlands Food and Consumer Product Safety Authority (NVWA).

We have assisted a manufacturer of medical devices in obtaining a derogation from conformity assessment procedures under the MDR in the interest of public health.

We have provided in-house training for the authorised representative of a large multinational on its obligations under the MDR.

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

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 advised an importers, distributors on a complex international supply chain strategy under the MDR.