EU-Coronavirus: Commission issues guidance to help increase production of safe medical supplies
The European Commission is making available guidance to assist manufacturers in ramping up production of essential medical equipment and material in three areas: the production of masks and other personal protective equipment (PPE), leave-on hand cleaners and hand disinfectants and 3D printing in the context of the coronavirus outbreak. These documents also aim to assist manufacturers and market surveillance authorities in making sure these products comply with necessary safety standards and are effective.
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.
The second document intends to provide guidance to economic operators including small and medium-sized enterprises on the applicable legal framework for the placing on the EU market of hydro-alcoholic gel (i.e. the Cosmetic Products Regulation or the Biocidal Products Regulation) and the claims which can be made to the user.
The third gives guidance on conformity assessment procedures for 3D printing and 3D printed products for medical use in the context of the coronavirus outbreak.