30 May How do you know if your mask is certified?

Following the scandal of the Chinese masks for Spanish health workers purchased by the government and the Autonomous Communities, 32% of which do not meet the efficacy requirements of the regulations, doubts have multiplied regarding the quality and certification of the masks to combat the coronavirus.

On Thursday and Friday of this week some media had access to the results of the 173 analyses carried out between March and May by the National Institute for Safety and Health at Work (INSST). According to this institution, which reports to the Ministry of Labour, only half of these masks, almost all of which are bought in China and marketed without CE marking, are of high quality.

According to the Organisation of Consumers and Users (OCU), the European Union’s Rapid Alert System (RAPEX) warned weeks ago of the presence on the European market of masks that do not comply with protection regulations. So far, they have been identified in five countries: Belgium, Denmark, Luxembourg, Croatia and Spain.

In this context, and aware of the concern that the quality of these articles arouses in the population, we explain below the general lines of the regulation of masks.

The CE marking process for respirators

According to Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment, PPE must be CE marked. Respirators intended to protect the wearer against inhalation of hazardous substances are understood to be PPE. They must therefore comply with this Regulation.

There may also be other types of masks that are not PPE. This is the case of surgical masks intended to prevent the transmission of infectious agents to the environment from the person wearing the mask. In this case, these would be medical devices (MPs) and are regulated by Directive 93/42/EEC.

However, where respirators are also intended to protect the wearer, then they must also be PPE. In that case they must comply with Regulation (EU) 2016/425.

For particulate filtering face masks, there is currently a harmonised standard cited in the Official Journal of the European Union. This standard is in accordance with Regulation (EU) 2016/425: EN 149:2001+A1:2009.

Masks can be classified as FFP1 (low efficacy), FFP2 (medium efficacy) or FFP3 (high efficacy). They are classified according to analyses that are carried out and are independent of the design or filter material used in their manufacture. In addition to the CE marking, both the mask and the packaging must be clearly marked with this classification.

The obligations of manufacturers are detailed in Article 8 of the regulation. Basically they provide that when a manufacturer places PPE on the market, he must ensure that it has been manufactured in accordance with the essential requirements of the regulation. Technical documentation and a product conformity assessment procedure must also be drawn up.

Verification and evaluation

Among other things, a notified body must examine the technical design of the PPE. It must also verify and certify that the technical design meets the requirements of this Regulation which apply to it.

If the assessment (tests, examination of documentation, etc.) carried out by the notified body is positive, the notified body shall draw up an assessment report. It shall also issue an “EU Type Examination Certificate” to the manufacturer. After this document, the manufacturer has to draw up the “EU Declaration of Conformity”, affix the CE marking on his product and can then start production and marketing.

During the production phase there shall be an “internal production control + supervised control at random intervals”, or a “quality assurance of the production process”. This ensures the conformity of production over time. All details on conformity assessment are explained in Article 19(c) of the Category III PPE Regulation.

More information can be found through the links in this article to the relevant legal instruments. If you have any doubts about the procedure to obtain a manufacturer’s or distributor’s licence for your product, or how to obtain the CE marking necessary to market it, EpisKey Medical Consulting SL can help you.