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Do you need a user manual for face masks?

INSTRKTIV Blog - Law & Legislation

We all have  to deal with it: The New Normal.

You will have noticed that quite a few things have changed in the past year. For example, in most countries it is mandatory to wear a face mask in public spaces and shops. 

Face mask appear in many forms and colors. 

In this article I will explain the different face masks. I will tell you what the requirements for the instructions for use are.  You will learn if a manual must be included or not.  

Face mask types

There are three types of face masks, namely:

  • Civilian face masks
  • Medical face masks (or surgical masks)
  • Face mask to protect the respiratory system

"Civilian masks", or masks that we wear every day on the train and in the supermarket, are masks that do not need to be certified.

On many websites you can find information about making face masks yourself, including instructions on how to wear such masks correctly. A CE mark and instructions for use are therefore not required. Easy.

However, the legal requirements for face masks suddenly become a lot more complicated if certain directives or regulations apply to the face  mask, such as for medical face masks or mouth masks to protect the respiratory system.

Medical face masks

The medical face mask is not intended to protect the wearer, but rather to protect the environment of the wearer. The mask thus reduces the risk of others becoming contaminated by the air the user exhales.

These surgical mouth-nose masks are a medical device within the meaning of Regulation (EU) 2017/745 and must therefore meet the requirements of the regulation. 

Because medical face masks fall under (risk) class I of the regulation, no requirements are imposed on the content of the instructions for use:

"Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section"

There is also a harmonised standard for medical face masks: the EN 14683. However, this standard does give requirements for packaging, labeling and product marking, but not for the instructions for use.

Mask as personal protective equipment

The third category of face masks are respiratory protection masks.

Respiratory protection masks fall under personal protective equipment within the meaning of Regulation 2016/425 and are intended to filter the air before you inhale it.

The masks fit closer to the face, reducing the chance of unfiltered air flowing past the mask.

The Regulation requires, in addition to the obligation to include the name and address of the manufacturer, in Annex II the following for the user instructions:

  1. instructions for storage, use, cleaning, maintenance, servicing and disinfection. 
  2. performance as recorded during relevant technical tests to check the levels or classes of protection provided by the PPE;
  3. where applicable, accessories that may be used with the PPE;
  4. where applicable, the classes of protection appropriate to different levels of risk and the corresponding limits of use; 
  5. where applicable, the month and year or period of obsolescence of the PPE or of certain of its components; 
  6. where applicable, the type of packaging suitable for transport; 
  7. the significance of any markings;
  8. the risk against which the PPE is designed to protect; 
  9. the reference to this Regulation and, where applicable, the references to other Union harmonisation legislation; 
  10. the name, address and identification number of the notified body or bodies involved in the conformity assessment of the PPE; 
  11. references to the relevant harmonised standard(s) used;
  12. the internet address where the EU declaration of conformity can be accessed

There is also a standard for this type of mouth mask: EN 149. The standard does not specify any specific requirements for the instructions.

Conclusion

There are different requirements for the different types of face masks.

Civil face masks do not fall under CE marking, so instructions  are not mandatory. Because these masks automatically fall under the General Product Safety Directive, they still do need to "be safe". A user manual may help to achieve this.

Instructions for use are not mandatory for medical face masks if they can be used safely without instructions.

When selling face masks on the European market as a non-European manufacturer, make sure you have found yourself an authorised representative within the EU.

For respiratory protection masks, a user manual is mandatory and clear requirements are also set for the content.

ferry vermeulen

Ferry Vermeulen

Founder of INSTRKTIV and keen to help users become experts in the use of a product, and thus to contribute to a positive user experience. Eager to help organisations to reduce their product liability. Just loves cooking, travel, and music--especially electronic. You can also find him on:
Profile PageLinkedin, Instagram and Twitter!


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