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Healthcare Litigation Update

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Over the past months, we have seen some interesting regulatory and enforcement developments that may impact healthcare and life sciences business in the Netherlands. This Healthcare Litigation Update sets out the implementation in the Dutch supervisory system of two new European Regulations that came into force, the In-Vitro Diagnostics Regulation and the Clinical Trials Regulation. Furthermore, several enforcement actions of Dutch health authorities are discussed, such as IGJ’s warnings against misleading COVID-test offers, NVWA’s enforcement action against an online drugstore for unlawful health claims, and NZa’s first administrative fine imposed on a de facto director.

New European Regulation on in-vitro diagnostics entered into force

Following the European Regulation on Medical Devices ( Regulation (EU) 2017/745 ) that entered into force in May 2021, in May 2022 the Regulation on In-Vitro Diagnostics ( Regulation (EU) 2017/746 ) entered into force. With the new IVD-Regulation entering into effect, IVD’s must comply with stricter rules before they are allowed on the European market.

The IVD-Regulation implements a complete revision of the current classification system of IVD’s. From now on IVD’s will be classified into four classes: class A, B, C and D. IVD’s from risk class B onwards must be certified by a […]

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