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The European Commission published guidance to help manufacturers accelerate the production of essential medical equipments and materials in the current health crisis. These documents also aim to help manufacturers and market surveillance authorities to ensure that these products comply with the necessary and effective safety standards.
The first document helps manufacturers to assess the applicable legal and technical requirements before importing new products into the EU, starting up new facilities or converting existing ones to produce protective equipment such as masks, gloves and surgical gowns.
The 2nd one aims to provide guidance to economic operators, including SMEs, on the legal framework applicable to the placing on the EU market of hydro-alcoholic gel (i.e. the Cosmetics Regulation or the Biocides Regulation).
- Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)
The 3rd provides guidance on conformity assessment procedures for 3D printing.