“The coronavirus outbreak requires support and collaboration from manufacturers,” the Commission says in its introduction to these guidance. “Companies have expressed solidarity and offered to provide practical and technical advice to each other to support increasing the production of personal protective equipments and medical supplies. The Commission is actively working with industry to promote the massive ramp-up of overall production of such material in the EU and is providing the necessary guidance to facilitate this.”
These documents also aim to assist manufacturers and market surveillance authorities in making sure these products comply with necessary safety standards and are effective.
This communication outline guidance on three fronts.

Personal protective equipments
The first guidance helps manufacturers to assess the applicable legal and technical requirements before importing new products to the EU or launching new or reconverting existing facilities to produce protective equipment like masks, gloves and surgical gowns to satisfy the unprecedented demand in the wake of the coronavirus outbreak.This guidance details the applicable EU legal frameworks and offers manufacturers’ advice on the concrete steps to take in order to be able to place their products on the EU market. It also explains the role of national authorities, in particular market surveillance …