The European Commission (EC) has announced harmonised standards for critical devices to ensure manufacturers can get their products to users as quickly as possible.
Products affected by the new standards are relevant for the fight against the current coronavirus pandemic, and the Commission seeks to reduce the regulatory burden on essential equipment. The EC said:
“Once implemented, the use of these standards will allow manufacturers of medical devices and other concerned economic operators, to comply with the health and safety requirements of the EU legislation, taking into account the most updated technical solutions. These standards, once referenced in the Official Journal of the European Union, grant conformity of devices with the requirements of the three Directives on medical devices.”
The standards revised in this move include:
- medical face masks
- surgical drapes, gowns and suits
Read the full Commission announcement here.