Conformity authorization necessary if masks are not sold?

By: DITECFER
Created: 7 April 2020 - 07:04
Updated: 7 April 2020 - 07:04

We have current and exptected shortages in chirurgical masks whose use is becoming mandatory also for "normal" people in our regions from these days. Moreover our family doctors have huge shortages in basic supplies to protect them from COVID.

For this we would like to manufacture "in house" masks for these categories for donations (no commercial purpose, no commercial channel used). We would like to manufacture either chirurgical masks (according to EN 14683:2019) or even the FFP-type (according to EN 149:2009).

Since not for commercial purposes, is it mandatory to follow the administrative process (though simplified) identified by our Government for conformity authorization?


Forum: Masks
Replies
10 April 2020
Conformity authorization

Hi. I don't have enough information to properly answer that question. That said, I have read differente articles with references to the the possibility of "self-certification" by manufacturers and importers, for some items.

Some references:

Confindustria Dispositive Medici

https://www.confindustriadm.it/emergenza-coronavirus/

Medical masks without CE marking: the National Health Institute and Confindustria Dispositivi Medici identify the necessary requirements for the placing on the market
https://www.bakermckenzie.com/en/insight/publications/2020/03/medical-masks-without-ce-marking-covid19

Dear forum users: do you have more information about this question? If so, please share here your knowledge.

Lucia Gonzalez
29 April 2020
Conformity authorization

Hi,

I remember ISINNOVA (the famous emergency masks which use a Decathlon snorkeling mask) having that same problem. This is what it is specified in their website :

"Usage by the patient is subjected to the acceptance of use of an uncertified biomedical device, by providing a signed declaration." 

Otherwise, in France the AFNOR developed two new categories of masks (certified for non-sanitary purposes) with some guidance here : https://masques-barrieres.afnor.org/.

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