Yearly Archives: 2020

Today, as part of the European Roadmap towards lifting coronavirus containment measures, the Commission is presenting guidelines on coronavirus testing methodologies. The guidance aims to support Member States in effectively using testing tools in the context of their national strategies and during the different stages of the pandemic, including when phasing out confinement measures. The Commission also aims to ensure that high-quality tools are available to assess the performance of the tests. Stella Kyriakides, Commissioner for Health and Food Safety,…

Dive Brief: The European Commission has cleared member states to deviate from normal procedures for overseeing notified bodies during the COVID-19 pandemic, per an amendment to implementing regulation published Tuesday. The Commission said member states can renew designations under the outgoing device regulations without performing the on-site assessment required in normal times. The legislation also relaxes the rules on surveillance and monitoring. The EC published the law on the same day as guidelines outlining when devices cleared for use by national…