Commission adopts revised harmonised standards for medical devices to respond to urgent needs in the COVID-19 crisis
The Commission decided yesterday to adopt revised harmonised standards relating to critical medical devices for the fight against COVID-19. Once published in the Official Journal of the European Union, these standards will grant conformity of devices with the requirements of the three Directives on medical devices.
The revised standards will allow manufacturers to place on the market high performing devices to protect patients, health care professionals and citizens in general, through a faster and less expensive conformity assessment procedure, and taking into account the most updated technical solutions.
This measure by the Commission follows the recent decision by the European Committee for Standardization and the European Committee for Electrotechnical Standardization, adopted upon the urgent request of the Commission, to make freely available a number of European standards for certain medical devices and personal protective equipment, as reported previously here on EU Law Live.
For more information, read the Commission’s press release.