Today, the European Commission published three guidance documents to assist manufacturers to increase 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. It also announced that in the next days a guidance document on medical devices will also be made available. These documents also aim to assist manufacturers and market surveillance authorities in making sure these products comply with necessary safety standards and are effective.
Commissioner for Internal Market Thierry Breton said:
We are acting swiftly and mobilising industry to increase and create new production lines for urgent health material and protective equipment across Europe. Many companies are already doing so, and we are helping them to ensure not only that this is done quickly but also that their products comply with all necessary safety standards.
1. 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.The guidance issued today 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 authorities in ensuring an adequate level of health and safety of equipment originating in third-countries, which is placed on the EU market.
2. 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. It aims at responding to frequent questions the Commission is receiving from operators of the cosmetic and of other sectors, which are heavily engaged in increasing or converting their production capacity towards these products.
3. The third guide gives guidance on conformity assessment procedures for 3D printing and 3D printed products for medical use in the context of the coronavirus outbreak. The document aims to detail the applicable EU legal frameworks for those products and sets out examples of technical standards which manufacturers may use in order to place compliant products on the EU market.
Guidance for personal protective equipment manufacturers
Guidance for hand gel manufacturers