Tag Archives: Medical Device Regulation

Effective date of EU Medical Device Regulation now officially delayed by 1 year

On 23 April 2020, the European Parliament and Council approved the European Commission’s proposal to delay the application date of the Medical Device Regulation 2017/745 (the “MDR”) by one year (from 26 May 2020 to 26 May 2021) by adopting New Regulation (EU) 2020/561 (the “New Regulation“). Unusually, the New Regulation took effect on the … Continue Reading

European Commission publishes proposal to postpone the application date of the Medical Device Regulations in response to COVID-19

The European Commission published today its proposal for the European Parliament and the Council to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) by one year.  This publication comes only 9 days after the Commission announced its plans to postpone the MDR (see the InsideEULifeSciences blog post here).  The European Parliament and … Continue Reading

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
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