Surgical masks or protective breathing masks: what is the regulatory difference?
In the context of Covid-19 pandemic, and especially with the end of the confinement getting closer, the demand in masks is considerably increasing. It is important to distinguish surgical masks, which are medical devices, from protective breathing masks, which are considered Personal Protective Equipment, or PPE.
Surgical masks: medical devices
Surgical masks are considered medical devices (MD) and are consequently subject to the European directives on medical devices, as well as the regulation EU n°2017/745 when its first deadline will apply in 2021. They are divided into 3 types depending on their filtration efficiency. These masks prevent the projection of droplets from the wearer. When they are splash resistant, these masks also protect the wearer from other people’s projections. It should be noted that they do not protect against the inhalation of very small airborne particles.
These masks are class I MDs and thus are “auto-certified”. This means that the manufacturer has to ensure the product is compliant with the legislation on medical devices, without having to go through a notified body. Additionally, the manufacturer has to respect the EN 14683 norm regarding medical use masks when manufacturing and testing the performance of their products.
Protective breathing masks: PPEs
Protective breathing masks, which are considered PPEs, are more protective for the wearer, even though more constraining to use. They are also divided into different classes varying with their efficiency. These masks, called FFP (Filtering Facepiece), are subject to the European regulation EU n°2016/425. These FFP masks must also comply with the EN 149:2001 + A1:2009 norm.
The manufacturer of this type of masks may designate a representative who will carry out the cooperation with authorities upon request or control. The manufacturer must, in any case, produce the technical documentation of the PPE, as well as an instruction sheet.
PPEs, like medical devices, must both have the CE marking appearing on the product.
EcoMundo’s experts guide you through your company’s compliance strategy to prevent potential shortages of masks linked to Covid-19.
Protective equipment: essential during the pandemic
Protective equipments (masks, gloves, etc.) are used to protect the wearer’s exposed areas against various risks (contact, projection, inhalation…). In the context of the Covid-19 pandemic striking worldwide, these products are more and more requested, whether it be by health professionals or by the general public. The need should continue to increase, with the end of the confinement, but also during these next few months.
In March, the European Commission adopted the Recommendation (EU) 2020/403 with the aim of promoting the development and import of PPE and medical devices in Europe by giving notified bodies and competent authorities the priority to products necessary to ensure protection in the context of Covid-19. This recommendation also reminds of the possibility to apply derogations to medical devices which do not yet have the CE marking.
Wish to know more about masks' compliance?
For more information, do not hesitate to contact Sylvain de Backer or one of our experts via our contact form, indicating the purpose of your inquiry.
