During the plenary session of the European Parliament in Brussels (08-11 February 2021), MEPs debate the corona crisis, in particular the homologation and distribution of transparent masks. Opening session by Jutta URPILAINEN, European Commissioner for International Partnerships.

Brussels

statement

debate

plenary session

medical devices (T)

medical device

protective equipment

URPILAINEN, Jutta (FI, EC)

Coronavirus outbreak (T)

virus

Homologation and distribution of transparent masks: Opening session by Jutta URPILAINEN, European Commissioner for International Partnerships

SOUNDBITE (Original) Jutta URPILAINEN, European Commissioner for International Partnerships, What we have at our disposal in the fight against a covid-19 virus is the face mask. Today specific requirements regarding the use of face masks have been introduced across the EU under the competence of each member state. However, with all of us now having to wear a face mask in certain settings, it is essential to ensure that everyone can find the mask that serves their needs while remaining safe.

SOUNDBITE (Original) Jutta URPILAINEN, European Commissioner for International Partnerships, In that respect, the recommendation issued by the European Centre for Disease Prevention and Control, as well as by the World Health Organisation. Are our trusted scientific references. The rules regarding the design, testing and placing on the market surgical and protective masks are laid down at EU level, respectively, by the directives and regulations on medical devices and by the regulation of personal protective equipment.

SOUNDBITE (Original) Jutta URPILAINEN, European Commissioner for International Partnerships, Furthermore, we have seen the emergence of other type of masks, these new products for which the manufacturer does not claim a corresponding intended protective or medical purpose are covered by the General Product Safety Directive. That requires all products placed on the EU market to be safe.

SOUNDBITE (Original) Jutta URPILAINEN, European Commissioner for International Partnerships, Our aim is to ensure that safe and compliant products can be placed on the market to meet the needs of all users, including vulnerable groups that rely on visual communication. The World Health Organisation estimates that over 5% of the world's population has disabling hearing loss. Being able to see the lips and facial expressions of the interlocutor are crucial for those who rely on visual communication, such as using sign language. This imperative could at first appear to be difficult to reconcile with the barrier function that the masks have to provide.

SOUNDBITE (Original) Jutta URPILAINEN, European Commissioner for International Partnerships, However, this is not the case for existing rules on medical devices as well as the PPE legislation are technologically neutral, which means that they don't prescribe specific technical solutions for the products. Any design, any choice of materials or components is acceptable as long as the entire mask complies with the defined performance requirements and ensures an adequate level of protection, according to the intendant use defined by the manufacturer.

SOUNDBITE (Original) Jutta URPILAINEN, European Commissioner for International Partnerships, I believe that the EU rules on PPE and on medical devices are suffering intensely flexible to accommodate face masks of any design and materials, including transparent face masks, as long as they need the same performance requirements as the more widely used non-transparent masks. I would like to stress that all the relevant actors, manufacturers, standardisation and testing bodies, member states authority is and the Commission should work in close cooperation to ensure that face masks continue to be a useful and safe tool in the fight against a covid-19 virus and to preserve the user's trust. Thank you.