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Tag: devices

US Contacts for Medical Devices During the COVID-19 Pandemic

The U.S. Food and Drug Administration (FDA) has published a new directory of email addresses for medical device questions during the COVID-19 pandemic. This directory includes contacts for questions about: • Emergency Use Authorizations (EUAs) • Device shortages • Enforcement policies and immediately in effect guidances for specific types of medical devices • Other topics, […]

New EU funds for Corona fight, reconstruction, medical devices – with video

In a strong sign of solidarity, the European Parliament, with support from the EPP Group and other mainstream parties, supports a €3 billion plan to help in the fight against the Coronavirus pandemic. It also backs more flexible financing for the recovery, front-loading spending and allowing short-term financing under the €400 billion European Stability Mechanism […]

Coronavirus: harmonised standards for medical devices to respond to urgent needs

Yesterday, the Commission adopted decisions on harmonised standards which will allow manufacturers to place on the market high performing devices to protect patients, health care professionals and citizens in general. The standards will facilitate a faster and less expensive conformity assessment procedure. The revised harmonised standards play a pivotal role in the current coronavirus pandemic […]