إجراء مقترح من الاتحاد الأوروبي: النباتات الحية، الأدوية واللقاحات، الأجهزة الطبية

Regulation (EU) 2017/745 on medical devices (MD Regulation) and Regulation (EU) 2017/746 on in vitro diagnostics medical devices (IVD Regulation) establish a new regulatory framework for medical devices and in vitro diagnostic medical devices. Their objectives are a high level of protection of health for patients and users and the smooth functioning of the internal market for these products. The MD Regulation has been applicable since 26 May 2021. It was notified to the WTO as notification G/TBT/N/EU/71. In March 2023, the European Parliament and the Council adopted a staggered extension of its transition period, ranging from 31 December 2027 for high risk devices to 31 December 2028 for medium and lower risk devices. It was notified to the WTO as notification G/TBT/N/EU/943. The IVD Regulation has been applicable since 26 May 2022. It was notified to the WTO as notification G/TBT/N/EU/72. In January 2022 and in July 2024, the European Parliament and the Council adopted a staggered extension of its transition periods, ranging from 31 December 2027 for high risk in vitro diagnostics to 31 December 2029 for lower risk in vitro diagnostics. They were notified to the WTO as notification G/TBT/N/EU/845 and G/TBT/N/EU/1044. Despite considerable progress made over the past years, multiple challenges regarding the implementation of the Regulations on medical devices and in vitro diagnostics, persist. The notified proposal is the immediate follow up of the targeted evaluation of the…