This page provides information to guide importers who are importing face masks into the EU. We make the distinction between face masks and FFP respirators, and explore the regulations and CE certification involved so you can make better and safer choices when choosing Chinese suppliers and products.
Page last updated: 12/6/20 – FAQ section on relaxed rules
1. What kind of face masks are you purchasing to import into the EU?
Europe is one of the hardest-hit regions by the Coronavirus infection and demand for face masks and other PPE has been huge.
Regarding importing face masks into the EU to be used in tackling Coronavirus specifically, there are 2 key European mask classifications which have differing regulations:
- Medical Devices (MD) – face masks to protect the environment (patient) from contamination by the wearer (practitioner). -> (MD or Medical Devices)
These fall under the scope of the Medical Devices Directive (MDD).
- Personal Protective Equipment (PPE) – filtering masks to protect the wearer against microbial and viral infections. -> (PPE, Category III)
These fall under the scope of the PPE Regulation.
Note: Masks with both functions, protecting the user and the environment, will be MDD and PPE.
There are other types of masks available (DIY and cotton masks, for example), but they may not be CE-certified as suitable for use in a medical environment or to protect the wearer from infection.
Harmonised EU Standards for face masks
If you now know which classification of face mask you’re going to be importing, it is helpful to understand the European health, safety and performance standards they must conform to.
Non-PPE medical device face masks
EN 14683:2019 for non-PPE type face masks (commonly known as masks, medical masks, face masks, etc) which are Medical Devices (MD).
PPE FFP respirators
EN 149:2001+A1:2009 for the FFP-type PPE masks (respirators).
They will all ultimately require a CE mark to be imported, that is to say, compliance with various European safety and regulatory requirements for their product type, however ‘PPE’ products do NOT require a clinical evaluation unlike MD.
Here is a video walkthrough explaining how to assess which classification of mask you’re dealing with: MD or PPE:
2. Face Masks - Classified as MD (Medical Devices) in the EU
Masks are typically Class I, II, or IIR medical devices (MD) that are meant to protect the patient or environment from the wearer. The classes are distinguished by BFE & Delta P (where class II and IIR have a higher efficiency) and whether they are ‘splash resistant (R).’
- Class I MD face mask: Lowest permissible conformities (see table below)
- Class II MD face mask: Higher BFE than class I
- Class IIR MD face mask: Higher BFE, Delta P, AND splash resistant
They all provide limited protection for the wearer against droplets, splashes, and, less-so, aerosols, but typically aren’t sold as PPE for this purpose (unlike FFP respirators), but only class IIR are actually rated as splash-resistant.
Laboratory testing for EU-bound masks
In order to conform with EN 14683:2019, the face masks will undergo the following testing to reach these performance requirements for the different types (I, II, IIR):
Bacterial filtration efficiency (BFE), %
This test measures how well the mask filters out airborne bacteria.
The goal is for a ≥95% success rate of filtering out penetrating aerosol droplets containing bacteria which are drawn through it in a lab environment.
Differential pressure (Delta P), Pa/cm2
This test measures the airflow through the mask which has an effect on wearability and user comfort. The goal is for a rate of <40 Pa/cm2.
Microbial cleanliness (ISO 11737-1:2018)
Test the population of viable microorganisms on or in a health care product, component, raw material or package with the goal rate being ≤30 cfu/g.
The masks must complete a biological evaluation as per ISO 10993-1:2018. Testing to (ISO 10993-5, 10) for skin sensitivity and cytotoxic tests as masks are in prolonged contact with skin.
The lab test results will be submitted as a part of the TF (Technical File) which makes up the CE mark registration process.
The CE marking process for masks
When importing face masks into the EU, gaining the CE mark is an integral element which allows them to be imported and sold in Europe. The process includes:
- Determine medical device (MD) classification (Class I, II, III)
- Choose conformity assessment procedure conforming with harmonised European standards (EN 14683:2019) OR another verified technical specification
- Select Notified Body for performance testing (not required for Class I MD unless sold as sterile)
- Implement Quality Management System (QMS) – If the manufacturer is ISO 13485 certified for medical devices this will assure safety & quality, however other forms of QMS may be acceptable.
- Prepare Technical File (TF) or Design Dossier – Includes bill of materials (BOM), design drawings, label files, packaging files, list of applicable EN standards or directives (such as EN 14683), laboratory test reports, product QC inspection reports, risk assessment
- Appoint an Authorized EC Designated Representative (for non-European suppliers)
- Audit by Notified Body of QMS and TF (not required for Class I MD unless sold as sterile)
- Register medical device – the product must be registered with the national authority of the country where it is to be imported to and sold because it is a medical device
- Manufacturer prepares Declaration of Conformity (DoC) – This self-declaration includes SKU, product features, user manual, contact details of manufacturer/importer, list of applicable EN standards or directives (such as EN 14683), manufacturing location, name of responsible individual.
The EU provide a thorough guide to drawing up your EC DoC.
- Affix CE mark – This will be on the product and its packaging. You can read CE marking regulations here.
Sterile Face Masks
If the masks are sold as sterile, tests and audits from a Notified Body will also have to be obtained. Aside from requiring production in a sterile environment and, perhaps, the use of different materials, the documentation will be different:
- The mask type information will include ‘STERILE.’
- The CE marking (on item and/or packaging) will be followed with the four-digit ID of the Notified Body involved in type testing the product and auditing production.
- The manufacturer’s QMS must be certified to EN ISO 13485.
Labelling on the MD face masks
The product and packaging will show:
- CE mark
- Standard EN 14683
- Type; I, II, or IIR
- Article number
- Identifying details about the business entity placing the product on
the market & CE declaration signatory
- Traceability information & batch code
- ‘Use by’ date
3. FFP Masks (respirators) - Classified as PPE in the EU
In European regulatory parlance, respirators are known as ‘FFP masks’ (Filtering Facepiece Particles) or respiratory protection masks.
Unlike class I MD masks, these tight-fitting masks are made mainly from filtering material to protect the wearer from harmful particles and aerosols, such as an airborne Coronavirus. Usually worn in medical settings, these masks must adhere to a different standard than class I MD masks and are not classified as Medical Devices at all, in fact they are classified as Category III Personal Protective Equipment (PPE) with a ‘complex design.’
What is PPE?
The EU defines PPE (personal protective equipment masks) as:
Disposable and reusable face masks ensuring protection against particulate hazards, disposable and reusable coveralls, gloves and eyewear protection, which are used for prevention and protection against harmful biological agents such as viruses are products falling within the scope of the Regulation (EU) 2016/425 and repealing Council Directive 89/686/EEC.
Classifying FFP masks
European Standard EN 149:2001+A1:2009 defines the following classes of “filtering half masks” which “are designed to protect against solids, water-based aerosols, and oil-based aerosols”:
|Class||Filter penetration limit(at 95 L/min air flow)||Inward leakage|
|FFP1||Filters at 80% of airborne particles||<22%|
|FFP2||Filters at 94% of airborne particles||<8%|
|FFP3||Filters at 99% of airborne particles||<2%|
Perhaps the most common global term for FFPs are ‘N95’ masks. This actually comes from the American regulations, so EU users must know that their rough equivalent is ‘FFP2.’ Additionally, in a medical setting it is likely that only FFP2 and FFP3 masks will be used as they filter a minimum of 94% of airborne particles.
Note: FFP3 respirators will conform to EN143:2000 if they have a higher aerosol filtration effectiveness of 99.95%. This standard will be indicated on their labelling.
FFP mask laboratory tests for CE certification
To be in compliance with EN 149:2001+A1:2009, FFP masks are tested to the following
CEN/TC 79/WG 9 – Test methods and interpretation of CEN/TC 79 standards:
- Determination of inward leakage and total inward leakage
- Practical performance tests
- Flame tests
- Oil resistance
- Determination of particle filter penetration
- Determination of dolomite dust clogging
- Mechanical stress test
Below you can see the list of EN149 requirements referring to the tests above and the pass requirement for FFP respirators:
The CE marking process for ‘Complex PPE’ like FFP masks
Following the lab testing, the process to gain the CE mark which allows them to be imported and sold in Europe is as follows (there are some differences between PPE and ‘medical devices’ like face masks):
- Determine PPE classification (Category I, II, III)
- Choose conformity assessment procedure from correct notified body – conforming with harmonised European standards (EN 149:2001+A1:2009) OR another verified technical specification
- Create testing and technical documentation
- Undergo EC-type examination by Notified Body
- Create Manufacturer’s Declaration of Conformity (DoC) – This self-declaration includes SKU, product features, user manual, contact details of manufacturer/importer, list of applicable EN standards or directives (such as EN 14683), manufacturing location, name of responsible individual.
The EU provides a thorough guide to drawing up your EC DoC.
- Affix CE marking – This will be on the product itself and may be on the packaging. You can read CE marking regulations here.
- EC quality control system for the final product OR System for ensuring quality of production by means of monitoring
Labelling on the FFPs to be imported and sold in the EU
In addition, each FFP respirator and packaging must be labelled with the following:
- Manufacturer’s name
- Mask reference
- CE number of the certification body + EN 149: 2001 + the mask class (FFP1, FFP2 or FFP3) + acronym (NR – not reusable or R – reusable)
- The marking must comply with Directive 89/686 / EEC on PPE. If any of these entries are missing, the mask will be considered non-compliant.
Here’s an example of how European FFPs must be labelled:
4. The CE certification checking process used for importing face masks into the EU
In this section, we will explain how we check CE certification in detail for both masks (class I MD) and FFP masks (PPE) which are going to be imported into the EU, as these products need to gain a CE-mark before they can be marketed and used.
Note 1: Surgical masks only protect the environment (patient) from contamination by the wearer (practitioner) are classified as Medical Device, falling within the scope of Directive 93/42/EEC and of Regulation (EU) 2017/745.
Class I devices, that are non-sterile, non-reusable and non-measuring, do not require a Notified Body (NB). All other products require Notified bodies’ involvement.
For detail of classification, please read: “CHAPTER III CLASSIFICATION RULES”
The EU Commission “categorization guide” on PPE 89/686/EEC specified in its explanation of category 7.3. that “surgical masks” were excluded of the scope of the PPE 89/686/EEC but added as a footnote (3):
“Where such masks are intended to protect the wearer against microbial and viral infections, etc. they are in certification category III (personal protection rather than medical use).”
The manufacturers of medical devices class I can choose one out of three possible CE marking routes.
Table 1: CE marking routes of Class I Medical Devices
The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of manufacturers in view of the low level of vulnerability associated with such devices.
For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory. But a QMS audit by a notified body is still mandatory.
The notified body shall audit the quality management system to determine whether it meets the requirements referred to in Section 2.2. Where the manufacturer uses a harmonised standard or common specification CS related to a quality management system, the notified body shall assess conformity with those standards or CS.
EU quality management system certificates and EU quality assurance certificates for class I devices for which the involvement of a notified body is required pursuant to Article 52(7) shall include a statement that the audit by the notified body of the quality management system was limited to the aspects required under that paragraph.
Ideally with the MD sample and the instructions for use – if there is a doubt, one can contact the notified body/competent authorities …
Search in the NANDO database to confirm the notified bodies for MD regulated (EU) 2017/745. (Not all MD notified bodies are competent for all types of MD, so you need to check the product scope).
You will see the notified bodies for MD in this list and then can reach out to them to check the CE-certification IF the NB has been involved in it:
How to contact the notified bodies to confirm the validity of the reports/tests?
- Try to check the report directly via the official website of the bodies (here are some examples of official bodies’ websites you may wish to check: BSI, TUV Rheinland, TUV Sud).
- If not, email or call the bodies.
Check if they changed the design.
For face masks (3-layer) only:
EN 14683 is a European standard
ASTM F2100 is an American standard
PPE products always require a notified body for testing, so checking their CE certification should usually be as easy as checking the NANDO database for ‘Regulation (EU) 2016/425 Personal protective equipment’ and finding the correct NB used for the products in question:
There are only 32 bodies for equipment providing respiratory system protection and none are in Asia, they are all in Europe and Turkey.
5. FAQs for importing face masks (medical devices) & FFP respirators to the EU
The rules have changed during the coronavirus pandemic as new information about the efficacy of predominantly Chinese FFRs (also known as KN95 masks) has come to light.
Originally in March 2020 authorities in the EU were prepared to temporarily accept PPE and medical products which adhere to their own domestic or WHO recommended safety standards and not harmonised EU standards (source):
“With the objective to ensure availability of PPE and medical devices for adequate protection in the COVID-19 outbreak, the Commission invites all economic operators throughout the supply chain, as well as notified bodies and market surveillance authorities to deploy all the measures at their disposal to support the efforts aimed at ensuring that the supply of PPE and medical devices throughout the EU market will match the continuously increasing demand. Such measures should nevertheless not have a detrimental effect on the overall level of health and safety and all relevant stakeholders should ensure that any PPE or medical devices, which is being placed on the EU market, continues to provide an adequate level of protection of the users’ health and safety.”
This point is relevant to foreign PPE:
“ In the case of PPE products manufactured following technical solutions other than harmonised standards, the WHO recommendations on the appropriate selection of PPE may be used as a potential source of reference for such technical solutions, provided that the said technical solutions ensure an adequate level of protection corresponding to the applicable essential health and safety requirements laid down in Regulation (EU) 2016/425.”
However, now in June 2020, authorities have now disallowed the use of Chinese KN95 masks as PPE for use as protection against COVID19.
According to the UK’s HSE (shared across the EU as well):
Personal protective equipment (PPE) cannot be sold or supplied as PPE unless it is CE marked. The only exception is for PPE that is organised by the UK Government for use by NHS or other healthcare workers where assessments have been undertaken by HSE as the Market Surveillance Authority.
KN95 must not be used as PPE at work as their effectiveness cannot be assured.
Masks that are not CE marked and cannot be shown to be compliant must be removed from supply immediately. If these masks have not been through the necessary safety assessments, their effectiveness in controlling risks to health cannot be assured for anyone buying or using them. They are unlikely to provide the protection expected or required.
If any are CE marked, suppliers must be able to demonstrate how they know the documentation and CE marking is genuine, supported by Notified Body documentation showing compliance with the essential health and safety requirements as required by the Personal Protective Equipment Regulations (EU) 2016/425.
Yes. Masks which have the properties of both MD face masks and PPE (i.e. they’re sold as protecting both the patient and the wearer) will have to conform with both harmonised standards: EN 14683 and EN 149.
The labelling of the masks will also have to include references to the 2 standards and they are classified as MD and should, therefore, be registered with the national authority where they’re being sold.
No, a CE certificate may be forged. The European Safety Federation has collected a number of examples of suspicious certificates.
A good idea is to request and check the accompanying ‘test report’ that makes up a part of the CE certification process.
This report will show you that the items you’re trying to purchase have passed the tests required by the harmonised EU standards.
Here is an example of a legitimate test report:
NO. The UK has left the EU, but is still within the transition period and follows EU regulations on medical devices and PPE for the time being.
The EC DoC (declaration of conformity) is a self-declaration issued by the manufacturer of the product as a part of the CE certification process. In the document the manufacturer, or his authorised representative within the EEA should (source):
- Indicate that the product meets all the necessary requirements of the directives applicable to the specific product
- Make sure it has the name and address of the manufacturer together with information about the product, for example brand and serial number
The DoC must be signed by an individual working for the manufacturer or his authorised representative, and indicate the employee’s function.
The CE certificate is issued by the notified body, probably a testing laboratory, which signifies that the product has reached the corrrect standards.
Both are usually required as a part of the CE-certification process.
No. Before placing an order, you need to check whether the vendor is authorized to export the products you’re buying before paying for an order. The consequences of not doing so may be that you pay for an order which China Customs will not allow to be exported.
The regulations are changing almost daily right now, therefore please check for new guidelines before exporting from China.
Here’s what we know, although the situation is changing rapidly. To reduce the chances of poor quality medical devices and PPE being shipped out of China, since April 1st 2020 the authorities there now demand the following:
- The medical supplies must hold a PRC Medical Device Product Registration Certificate.
- The registration number for the supplies must be provided to China Customs as a prerequisite for export.
Only better-established Chinese vendors can provide this information, therefore it will reduce supply, but also stop many newer exporters from providing supplies which may not be up to standard.
On April 10th the Chinese government went further, announcing that China Customs will be checking the quality of medical supplies bound for export, including face masks, PPE, ventilators, disinfectant, etc. This is bound to slow down the process.
Summary (as of 21st April)
- Your supplier must be officially licensed in China to manufacture the product.
- They must be authorized to export that product from China (the requirements surrounding this are changing rapidly, but it includes most MD & PPE face masks).
- The paperwork submitted to China Customs must be 100% correct and double-checked (they are scrutinising it strictly for errors or inconsistencies).
- The product must be of good quality and not counterfeit (they are checking quality at the border).
- The importing country is legally permitted to receive such items (see the EU’s declaration about permitted non-conforming foreign medical supplies here).
Probably not. Due to the demand, testing labs are swamped and are giving lead times of several months for certain tests. During the coronavirus pandemic when you need goods now, running new lab tests is probably unrealistic.
Even if you can’t run new lab tests, you can focus on paperwork, auditing, and inspections to reduce risks:
- Due diligence on suppliers before placing orders – are they legitimate manufacturers, are they legal?
- Certificate verification – is their CE certificate real? Are the documents they provide for the correct products?
- Factory audits – this may be more effective if you are placing very large orders (millions of pieces), but they will allow you to know that the factory is capable of producing the products you need at the right standards.
- Product inspections – gives you the security that your products are good quality before they are shipped.
A barrier mask, also known as a DIY mask, can be used to provide the wearer and others with some protection against coronavirus infection.
Since many governments are advising that masks should be worn by the general public, for instance, in Germany it’s now mandatory to wear masks in public, there is a concern that the already scarce supplies of medical masks and PPE will come under even more pressure. Therefore, masks for non-medical use are a good alternative, and even the CDC has suggested people make DIY masks and provided guidance.
These masks are not within the scope of MD or PPE and do NOT conform with the harmonised EU standards EN 14683 for medical masks or EN 149 for respiratory protective devices (PPE).
AFNOR has created a new standard for these masks which will help importers to classify them and police their quality: AFNOR SPEC S76-001 “Masques barrières” or “Barrier Masks” for general purpose woven masks.
The standard includes:
- Visual Inspection & Dimensions
- Particulate filtration %
- Delta P (breathability)
- Marking & Product Labelling
- Packaging & Production Materials
- Cleaning and Drying instructions (as these masks are meant to be cleaned and reused
You can learn more about this standard here (link in French, use browser to translate).
The laboratory tests for Chinese standards should be performed by a lab that is listed in this directory and is authorized for this kind of product.
I hear that the EU's new Medical Device Regulation (EU) 2017/745 is coming in soon. Will this affect importers of medical devices like surgical masks?
No. It is true that there is a new MD regulation coming into force (Medical Device Regulation (EU) 2017/745), but it has been postponed until 2021 to help importers focus on the fight against COVID-19. Read more about this here.
However, if you are an importer, becoming aware of the new regulation now is not a bad idea so you can be prepared in time!
The EU has created this helpful guide demonstrating how to legally place medical devices and PPE on the EU market, and therefore safely purchase and use them, too.
It explains the procedure for legally placing markets for sale, what a certificate of conformity should include, what testing reports are, and much more.
Remember, importers of medical devices and PPE can be held responsible for illness or injury caused when using the products if it’s found that they were not compliant with the correct EU regulations, therefore understanding the legalities is important.
Sofeast’s indemnity and notes for the reader
- We are not legal professionals and any information provided here about the regulations and standards when importing face masks into the EU is only given for your reference. We do not accept responsibility for any issues you may face after using this information.
If you are unsure about the validity of your face masks, please refer to the EU’s official documentation, a CE-accredited notified testing body, or a local legal professional for assurance before importing face masks from China to the EU.
- This page will be updated periodically as we find useful new information. If you have a suggestion for a change or an addition, please contact us.