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Coronavirus: European Standards for Medical Supplies Made Freely Available to Facilitate Increase of Production

In the context of the Coronavirus crisis, the Commission is working with industry and Member States to maximise the availability
of masks, gloves, gowns and other medical supplies. Efforts include increasing production by existing manufacturers, facilitating
imports and activating alternative ways of producing equipment.

Upon the urgent request of the Commission, the European Committee for Standardization (CEN) and the European Committee
for Electrotechnical Standardization (CENELEC), in collaboration with all their members, have agreed to immediately make
available a number of European standards for certain medical devices and personal protective equipment. This action will help
both EU and third-country companies willing to manufacture these items to swiftly start production and place products on the
internal market more easily while ensuring a high degree of safety.

Commissioner for Internal Market Thierry Breton said: “We need to act collectively with urgency, solidarity, and audacity. I am
encouraging manufacturers to increase and diversify production, building on positive examples such as textile and shoe
manufacturers starting to produce masks and gowns. I will do everything possible to support their efforts. I am pleased to
announce that following contacts with the Commission, CEN/CENELEC has agreed to make freely available the standards
needed for such companies to be able to produce masks and other protective equipment.”

Today’s agreement has immediate effect. The 11 standards developed by CEN and potentially 3 additional ones
developed jointly with ISO that are made available cover common filtering masks, medical gloves and protective clothing.

This initiative complements the Commission Recommendation on the conformity assessment and market surveillance
procedures, which provides guidance to national bodies on allowing non CE-marked personal protection equipment that
comply with the necessary health and safety standards to enter the EU market within the context of the Coronavirus.

How the free access to these standards helps increasing production

Providing free access to the national adoptions of these European standards helps both EU and third-country companies which
are reconverting their production lines to manufacture quickly these critical items for preventing the coronavirus pandemic.
The use of the standards will enable companies that use them to access the market for such fundamental medical and protection
equipment quicker and to provide those in need with such medical equipment.

Normally, standards must be purchased and used in line with the intellectual property right rules, as the copyright of the standards
lies with the organisations, which have developed the standards. The derogation from this business model is a strong European
response, based on a sense of social responsibility and solidarity, to address the shortage problem of protective equipment deriving
from the Covid-19 epidemics.

The standards are available for free download from the websites of CEN national members.

Background

European standards are an essential pillar of a fully functioning internal market. They reduce costs, promote innovation, ensure
interoperability between different devices and services, and help companies to access markets.

To support EU product legislation, the Commission can request the development of European harmonised standards to facilitate
compliance by manufacturers of the relevant requirements. Once agreed and referenced in the Official Journal of the European
Union, these harmonised standards become part of EU law and allow companies an easy and direct access to the internal market
for their products, while ensuring a high degree of safety for consumer.

European legislation for medical devices and personal protection equipment does also rely on harmonised standards.
In our common effort to face the corona virus outbreak, the Commission and the European Committee for Standardization (CEN)
have agreed to make a number of harmonised standards for important protective equipment like face masks and single-use gloves
freely available to those companies that are willing to start producing these items.

For More Information

List of available standards:

In addition, possibly:

European Standards

European Committee for Standardisation

European Committee for Electrotechnical Standardisation


Click Below to download a .pdf copy of the European standards for medical supplies


Published: 20th March 2020

Source: European Commission

Page URL: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_502