05 May


Covid-19: the EU Commission provides clarifications on the production of safe medical supplies


The Commission has published three guidelines for manufacturers in order to increase the safe manufacture of medical equipment given the ongoing pandemic, mainly as regards masks and other personal protective equipment (PPE), non-rinse cleansers and hand disinfectants, and 3D printing for medical use.

The first guideline (containing "Conformity assessment procedures for protective equipement") provides indications for assessing the legal and technical requirements for the production of protective devices such as masks, gloves, and surgical gowns (which are in large part considered personal protective equipment, and therefore fall within the scope of Reg. 2016/425), as well as the manufacture of devices for intensive care and other medical equipment (which may fall within the field of application of the legislation on medical devices).

The second guideline, containing "Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)", provides useful tools for the correct qualification of hand cleaners and disinfectants, and clarifies when a product is to be intended as cosmetic or biocide for regulatory purposes. The document mainly serves to provide indications on the correct interpretation of labels that use terms such as "anti-bacterial": these always require a case-by-case assessment, given the manner in which the product is presented to the consumer as a whole.

The guidelines for "Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19" provide indications on the conformity assessment procedures for 3D printing and 3D printed products for medical use. It refers to applicable legislation within the EU, which includes the "harmonised European standards", and provides indications on the correct qualification of such products, which may also fall into the category of medical devices, with the consequent application of current regulatory provisions on the matter (the text of the Guidelines is available on the European Commission website, at https://europa.eu/european-union/index_en).