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/surgical face masks and gloves that are intended to provide a barrier and to protect the patient and hospital staff from direct transmission of infective agents and be used in a medical, surgical or dental setting are classified as Class I medical devices and should be CE marked in accordance with the essential requirements of Directive 93/42/EEC on medical devices (MDD). These devices require notified body oversight if they are sterile devices.

Harmonised standards may be used to demonstrate conformity to the Directive, 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 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 MDD. In this scenario, Article 1 (6) of the MDD and the Commission’s Interpretative Guide (2009) contains information on the interface between PPE and medical device legislation. This guide sets out that where a product is intended for both PPE and medical device use, the product is covered by the MD Directive and must comply with the legal requirements of this Directive. In addition, the product must meet the relevant basic health and safety requirements (BHSR) of the PPE legislation.

The Commission’s Blue Guide (Chapter 2.6) provides further guidance on the simultaneous application of multiple pieces of legislation. Manufacturers should determine on a case-by-case basis which basic health and safety requirements and conformity assessment procedures are applicable to their product from the PPE legislation, taking into account its specific intended purpose.

While the device must meet the requirements of both pieces of legislation, the manufacturer only needs to affix one CE mark to the device. This requirement is set out in Article 4 (5) of the MD Directive. Where notified body oversight is required for the applicable conformity assessment procedure, either the PPE legislation or the MD Directive, 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

Contact Details

Further queries regarding the application of the MD Directive can be sent to devices@hpra.ie