The Euro­pean Com­mis­sion has updat­ed its Q&A doc­u­ment on con­for­mi­ty assess­ment pro­ce­dures for pro­tec­tive equip­ment like face masks, gloves, cov­er­alls, etc.

The cor­re­spond­ing doc­u­ment can be down­loaded here.

Fur­ther­more, the Euro­pean Com­mit­tee for Stan­dard­iza­tion (CEN) has pub­lished a guid­ance doc­u­ment on com­mu­ni­ty face masks. From a reg­u­la­to­ry per­spec­tive, com­mu­ni­ty masks do not ful­fill the def­i­n­i­tion of a med­ical device or PPE. Still, the doc­u­ment may be help­ful for man­u­fac­tur­ers of these prod­ucts to main­tain min­i­mum qual­i­ty stan­dards. Please get in touch should you require a copy of the document.

Source: Euro­pean Com­mis­sion, CEN

To receive fur­ther infor­ma­tion on this sub­ject, please notice the fol­low­ing articles