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

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 have a principal intended action based on proanthocyanidins (“PACs”) do not fall … Continue Reading

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

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 opportunity to have a closer look at one of the essential questions … Continue Reading

EU Medical Devices Regulation Series on Key Issues

It has been fairly quiet since the political agreement was reached last June on the EU Medical Devices Regulation (“the Regulation”). While the Commission’s lawyer-linguists iron out the final language, paving the way for formal adoption in the coming months, we are preparing a series of articles, beginning with this blog post, to address key … Continue Reading

Is Medical Software a Medical Device? European Court of Justice to Decide

On June 13, 2016, the French Conseil d’État (supreme administrative court) referred to the EU Court of Justice (“CJEU”), the question of whether medical software that provides support to healthcare professionals in prescribing medicinal products should be considered a medical device under Directive 93/42 (the “Directive”) (Case C-329/16).  The qualification of software as a medical … Continue Reading

First European Commission Borderline Decision: Does it Answer or Raise Questions?

The European Commission is preparing its first borderline decision under Article 13(1)d of Medical Devices Directive 93/42 (“the Article 13 Decision”). The draft is available here. This provision allows Member States to request that the European Commission decide whether a specific product should be considered a medical device.  The draft Article 13 Decision holds that … Continue Reading
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