Regulations and directives


1 - 4 of 4 items

Regulation on the evaluation of the safety of clinical trials

Regulation on the evaluation of the safety of clinical trials

Thursday, 13 de January de 2022

COMMISSION IMPLEMENTING REGULATION (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials.

Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation

Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation

Monday, 20 de December de 2021

In the context of the COVID-19 pandemic Member States, health institutions and economic operators redeployed financial and other resources to address the unprecedented challenges of the crisis. By doing so, they delayed the implementation of the In Vitro Diagnostic Medical Devices Regulation of 2017, which introduced certain requirements for medical devices and a stronger role for so-called conformity assessment bodies. 

Public health: Stronger rules on medical devices

Public health: Stronger rules on medical devices

Thursday, 27 de May de 2021

The new EU rules on medical devices (MDR) enter into application, establishing a modern and more robust regulatory framework to protect public health and patient safety. The new rules start applying after a one-year postponement due to the unprecedented challenges of the coronavirus pandemic, addressing the need for an increased availability of vitally important medical devices across the EU.