Regulatory requirements for medical face masks – European Commission Guidance

Regulatory requirements for medical face masks – European Commission Guidance

In the context of the COVID-19 pandemic, the European Commission has published a guidance document concerning the regulatory requirements for medical face masks in support of their production and/or placing on the market.

A medical face mask (also known as surgical or procedure mask) is a medical device covering the mouth, nose and chin, ensuring a barrier that limits the transition of an infective agent between the hospital staff and the patient [1]. The medical mask can be used by healthcare workers in their professional environment and, in face of the current situation, they are recommended to be worn by all persons (as indicated by the World Health Organization or national Governments) whether they are symptomatic or asymptomatic, in order to prevent the spread of the virus.


Medical face masks are products falling under the EU legal framework on medical devices – Directive 93/42/EEC (MDD), to be replaced by Regulation (EU) 2017/745 (MDR) as from 26 May 2021. However, there are other types of masks that fall under different Directives/Regulations, hence, under different legal requirements, such as:

  • Protective face masks, which are considered as personal protective equipment (PPE) and are regulated by the Regulation (EU) 2016/425 (PPER);
  • Face covering mask (community/artisanal/textile/domestic/non-medical face masks), for which the General Product Safety Directive (GPSD) 2001/95/EC applies (no CE marking labelled) - as there are no other specific requirements in the EU regulatory framework that concern them.

Medical masks falling under the MDD or MDR, must, among others, be CE-marked and accompanied by the EC or EU declaration of conformity issued by the manufacturer. In case of non-EU manufacturers, they need to designate a single authorized representative (EAR) in the EU, who must assume responsibility for placing the device on the EU market, ensuring that European and national regulatory frameworks are complied with.


This EC guidance document intends to help the industries that are willing to increase the production of medical face masks in supporting the availability of these products on the EU market. In doing so, the following options are presented:

1. Supplying semi-finished or finished face masks to medical devices manufacturers currently placing the masks on the market [2].

This option allows producers that are not currently working in the medical devices field (and/or others) to support the production of those manufacturers who already comply with all the legal requirements, in placing face masks on the market under their own name [3]. They can do this by providing semi-finished or finished products and, therefore, becoming suppliers or subcontractors of the actual manufacturer.

Hence, the producer will manufacture the face masks, but the medical device manufacturer appearing on the label will remain the legal manufacturer and shall comply with the concerned MDD or MDR requirements.


2. Derogation   procedure:   placing   on   the   market   authorized   by   the   competent authorities of a Member State in the interest of public health [4].

This option is possible due to Article 11(13) of the MDD and Article 59 of the MDR, which allow the competent authorities of a Member State - on duly justified request - to authorize, on its market, the placement of a specific device, for which the relevant conformity assessment procedures have not been carried out, but the use of which is in the interest of public health or patient safety or health [5].

Because of this ‘allowance’, it will be under the responsibility of the concerned competent authority to assess if these devices conform with an adequate level of safety and performance in accordance with the legal requirements or standards.

In case the competent authority decides to authorize the entry of the device on its national territory, the European Commission and their counterparts in the other Member States will have to be informed of any temporary agreement they have granted to these specific devices.

In exceptional cases relating to public health or patient safety or health, the European Commission can extend the validity of such an authorization granted by a single Member State to the whole EU territory and set the conditions under which the device may be placed on the market, or put into service for a limited period of time.


3. Manufacture of the finished face masks by a producer currently not placing face masks on the market under its own name [6].

Producers of medical face masks who are not currently medical device manufacturers under MDD or MDR will need to fulfil all requirements of these legislations before placing on the market products under their own name. The manufacturer who places the finished CE-marked face mask on the EU market under its own name must ensure that the device complies with the legal requirements and provide relevant evidence [7].

As previously mentioned, if the finished CE-marked face mask is produced outside the EU and imported into the single market, the legal manufacturer must designate an EAR, who will assume responsibility for placing the device on the EU market.


For more details on the proposed options, please visit the full document here.


Bianca Sofian

Junior Consultant, Regulatory Affairs & Quality Assurance Department

31/07/2020


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[1] Guidance on regulatory requirements for medical face masks. Options for supporting production and/or placing on the market of medical face masks in the context of COVID-19 pandemic, EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health systems, medical products and innovation Medical Devices, page 1.
[2] Id., p. 5.
[3] Ibid.
[4] Id, p. 6.
[5] Ibid.
[6] Id., p. 7.
[7] Ibid.