COVID-19 Masks: Rules for Production or Import

This article defines the key aspects for producing, importing, distributing, or purchasing protective masks during the COVID-19 emergency. Technically, protective half-masks.

Since the beginning of the health emergency, a silent battle has been ongoing in intensive care units due to the difficulty in obtaining face masks.

The solution adopted by the Government to meet the growing demand was to define a simplified mechanism for placing products on the Italian market. Called derogation validation. (Decree-Law March 17, 2020, n.18 art. 15 paragraph 2 Medical devices and paragraph 3 P.P.E.)

In detail, non-compliance with the normal certification process is allowed.

This concession has allowed new commercial channels to open, bringing economic and social benefits and has acted as a bridge between manufacturers (often non-European) and Italians.
On the other hand, many companies, having no previous experience in this field, found themselves importing large quantities of products, often inadequate.

Personal Protective Equipment, Medical Devices, and Products for Civilian Use

Not all half-masks are the same; without going into technicalities, these are the aspects to consider.

Personal protective equipment (filtering face masks)

• Devices to protect the user from external agents (including transmission of droplet and aerosol infections);
• They are used in hospital, care, and work environments;
• Only FFP2 (R/NR/D) and FFP3 (R/NR/D) categories are effective for the COVID-19 emergency;
• Certified according to regulation (EU) 2016/425, they fall under Cat. II and Cat. III.

Medical device (surgical masks)

• Devices to prevent the wearer from contaminating the environment, as they limit the transmission of infectious agents;
• They are used in hospital environments and places where patient care is provided (e.g., health centers, clinics, etc.);
• All categories are effective: Type I, Type II, Type IIR;
• Declared compliant under Directive 93/42/EEC or Medical Device Regulation (MDR) 2017/745, they fall under Class I.

Product for civilian use (other types of masks different from the above)

• Devices whose effectiveness for the COVID-19 emergency is obtainable only if supported by other social distancing measures.

Packaging, Labeling, and Accompanying Documents

The derogation validation discussed above has modified some obligations previously required for the products concerned.
In orange the additional information currently considered valid, strikethrough those currently not mandatory.

Personal protective equipment (filtering face masks)

• CE marking. Followed by the 4-digit identification number of the Notified Body if P.P.E. of Cat. III ;
• Identification of the manufacturer and product code;
• Identification of the reference standard (EN 149:2001+A1:2009 or Non-European equivalent such as China GB2626-2006; United States NIOSH-42CFR84; etc.);
• Performance category:
  • European: FFP2 (R/NR/D) or FFP3 (R/NR/D);
  • Chinese: KN95 or higher;
  • USA: N95 or higher;
• Definition of the possibility of reuse for multiple work shifts or for a single work shift;
• Disinfection method, where applicable;
• Instructions for use.

Medical device (surgical masks)

• CE marking;
• Identification of the manufacturer and product code;
• Identification of the reference standard (EN 14683);
• Performance category: Type I, Type II, Type IIR;
• Evidence of single-use nature, if applicable;
• Non-sterile/sterile indication and related expiration date;
• Batch number;
• Disinfection method, where applicable;
• Instructions for use;
• Declaration of conformity issued by the manufacturer according to Directive 93/42/EEC or Regulation (EU) 2017/745;
• Declaration: “Made pursuant to art. 15 paragraph 2 of D.L. March 17, 2020, n.18”.

Product for civilian use (other types of masks different from the above)

Products for civilian use have no obligations in terms of information to be provided to the end user. These are always without CE marking and should be clearly declared as not P.P.E. and not MD.

We are Receiving many Requests

We are receiving many requests during this period and there are many variables not considered in this article. If you need specific support to produce, import, distribute, or purchase COVID-19 related devices in Italy, you can contact us.