Charlotte Ryckman

Charlotte Ryckman

Charlotte Ryckman assists clients across a complex range of regulatory, legal and procedural matters. Her practice focuses on the European Union rules and on the laws in key EU Member States, including Belgium and The Netherlands.  Ms. Ryckman has experience in assisting pharmaceutical and medical device companies in a variety of life science regulatory matters. She also advises international companies on data privacy matters such as data breaches and international transfers. Ms. Ryckman has been involved in representing some of these companies in high-profile litigation matters in Belgium.  Ms. Ryckman’s practice also focuses on environmental and product safety matters, particularly regarding telecommunications.

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EU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices

This article was originally posted on our sister blog Inside Medical Devices The EU Regulatory Committee on Medical Devices recently voted in favor of the European Commission’s draft decision on the classification of cranberry products (the “Cranberry Decision”).  In essence, the Cranberry Decision provides that cranberry products intended to prevent or treat cystitis and that … Continue Reading

EU Medical Devices Regulation Series: Potential for Easing Borderline Determinations?

This article was originally posted on our sister blog Inside Medical Devices Earlier this week, in a plenary vote, the EU Parliament endorsed the texts of the Regulation on Medical Devices (the “Regulation”—latest version available here) and the parallel Regulation on In-Vitro Diagnostic Medical Devices (the “IVD Regulation”—latest version available here).  This presents a good … Continue Reading

IVD Regulation and Companion Diagnostics – EU Council Dramatically Changes Definition

This post was originally published on our sister blog Inside Medical Devices. On June 19th, 2015, the Council of EU Ministers reached a partial General Approach on the review of the medical devices and in vitro medical devices (IVD) rules in the EU (an overview of the texts is accessible here).  The General Approach does … Continue Reading

ECHA Steps Up its Enforcement Powers Under the REACH Regime

In a move that illustrates a continued political will to step up its enforcement powers, the European Chemicals Agency recently sent out REACH Article 36 letters to 46 companies that according to ECHA failed to correct their registration dossiers of intermediate substances.  Under the EU REACH Regulation, intermediates are subject to less burdensome registration substances … Continue Reading
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