Regulation of Face Masks and Gloves
The regulation of face masks and gloves differs depending on the product type and its intended purpose. Face masks and gloves may be considered Personal Protective Equipment (PPE), Medical Devices or, in some instances, they can be considered both. The European Commission has developed a guidance document to help economic operators verify if medical devices and PPE are lawfully placed on the market.
Personal Protective Equipment (PPE)
Respirator face masks and gloves intended to protect the wearer from exposure to airborne contaminants and from hazardous substances are classified as PPE and are regulated in accordance with Regulation (EU) 2016/425. The Health and Safety Authority (HSA) is responsible for the regulation of PPE and further information, including information on respiratory PPE, is available on their website.
Medical Devices
Medical or surgical face masks and gloves that are intended to provide a barrier to minimise the direct transmission of infective agents from staff to patients during surgical procedures are classified as Class I medical devices. These products should be CE marked in accordance with the essential requirements of Regulation (EU) 2017/745 on medical devices (MDR). These devices require notified body oversight if they are sterile devices.
Harmonised standards may be used to demonstrate conformity to the Regulations, for example, technical specifications for medical/surgical face masks are addressed by EN 14683:2019. Further information on harmonised standards is available on the European Commission’s website.
For any queries related to medical/surgical face masks or other medical devices, please contact devices@hpra.ie.
Dual Purpose Masks and Gloves
In certain instances, face masks and gloves may meet the definitions of both PPE and a medical device. These products will be considered to have a dual purpose and will fall within the scope of both the PPE Regulation and the MDR.
The Commission’s Blue Guide (Chapter 2.6) provides further guidance on the simultaneous application of multiple pieces of legislation. Dual purpose face masks and gloves must comply with all applicable provisions and must undergo the conformity assessment procedures according to all applicable legislation, unless otherwise provided for.
While the dual-purpose product must meet the requirements of both pieces of legislation, the manufacturer only needs to affix one CE mark to the device. Where notified body oversight is required for the applicable conformity assessment procedure, either the PPE legislation or the MDR, the notified body number should be indicated below the CE mark. If notified body oversight is required in accordance with both pieces of legislation, then both notified body numbers may need to be indicated.
European Commission Covid-19 Guidance Related to PPE