Planning to import medical or protective face masks to the European Union? In this guide, we cover product regulations, EN standards, labeling, certification, and lab testing requirements when importing or manufacturing various types of face masks for the EU.
Mentioned Products
- 3-ply surgical face masks
- 4-ply- surgical face masks
- 5-ply surgical face masks
- FFP1 mask or respirators
- FFP2 masks or respirators
- N95 masks or respirators
- FFP3 masks or respirators
- N99 masks or respirators
Content Overview
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Compliance Risks
Far from all medical and protective face masks on the market are designed to comply with EU standards and regulations. It’s therefore essential to request and verify all relevant compliance documents and lab test reports, and product labels, before importing face masks from suppliers in China, or other countries.
Checklist
- Confirm applicable standards/regulations for the specific type of face mask
- Request and verify lab test reports
- Request Declaration of Conformity
- Check product and packaging labels
Filter Capacity Classification
Note that while the “FFP” standards are maintained by the European Committee for Standardization (CEN), the “N” standards are released by the American National Institute for Occupational Safety and Health (NIOSH).
Here their respective filter capacity:
- FFP1: at least 80%
- FFP2: at least 94%
- FFP3: at least 99%
- N95: at least 95%
- N99: at least 99%
Also, note that KN95 is a standard maintained by the General Administration of Quality Supervision, Inspection and Quarantine of the PRC, which is considered to provide performance similar to N95.
Surgical Masks: Medical Devices Directive (MDD)
The Medical Devices Directive (MDD) applies to medical devices to be placed in the EU market, as such, surgical masks, which are mainly designed to protect the patient, fall under the scope of the MDD. The directive sets requirements for face surgical masks such as testing procedure, classification, safety performance and more concerning the face mask products.
Generally speaking, surgical masks are classified as a Class I medical device. However, if your masks are sterile, then they classified as Class I (sterile).
Also, note that according to the 2007 amendment of the Directive, when the mask is designed to protect both the patient and the wearer, it shall comply with the PPE Directive as well.
Medical Devices Directive Lab Testing
To ensure the product’s effective safety and performance, your face masks shall be tested in order to prove compliance with the MDD requirements. With that said, third party lab testing is the only way to verify whether your face masks are compliant or not.
EN 14683 Harmonized Standard
The EN 14683: Medical Face Masks is a harmonized standard under the MDD, and provides requirements and test methods for medical face masks.
In general, the EN 14683 standard classifies the masks into three categories based on their performance. Here we list an overview of those three types of masks:
| Test | Type I | Type II | Type IIR |
| Splash resistance, mmHg | – | – | 120 kPal |
| Bacterial filtration efficiency (BFE), % | ≥95% | ≥98% | ≥98% |
| Differential pressure, mm H2O /cm² | <3.0 | <3.0 | <5.0 |
| Microbial cleanliness | ≤30 | ≤30 | ≤30 |
Note that the “R” indicates that the mask offers protection for liquid splash, while other performances such as BFE remain the same.
Testing Companies
There are several accredited testing companies that provide MDD testing services for face mask products, which include Bureau Veritas, SGS, Intertek, and TUV.
Quality Management System (ISO 13485)
If your surgical masks are classified as sterile, then the MDD requires that the manufacturer has a quality management system (QMS) in place. Even though it’s not mandatory, the easiest way to comply with the Directive QMS requirements is to choose a manufacturer that is ISO 13485 certified.
ISO 13485, which is a harmonized standard under the MDD, indicates that the manufacturers are in compliance to design, develop, produce and deliver safety medical products. The standard covers workers, machines, materials, methods, production environments, and product safety.
Note that, even if for non-sterile masks a QMS is not compulsory, if possible, it’s still recommended to select a manufacturer that is ISO 13485 certified.
Notified Body
If your masks are classified as sterile, then the Certificate of Conformity shall be issued by a notified body, such as the above-mentioned companies (Bureau Veritas, SGS, Intertek, or TUV) or another notified bodies.
EU Authorized Representative (EC Rep)
If your company is not based in the EU, you shall appoint an Authorized Representative, which holds the documentation – see sections below in this article to learn more about the required documentation such as DoC, Technical File and more – and is responsible to keep them updated.
If your company is based in the EU, you can either act as the Authorized Representative or choose to appoint a third-party Authorized Representative.
Note that the labeling, packaging or user manual shall include the name, address, and symbol of the Authorized Representative.
Product Registration
Your face masks shall also be registered within the relevant authority in the EU country where either your company or your authorized representative is based.
Learn More
You can learn more about the Medical Device Directive in this article.
Protective Masks and Respirators: PPE Directive
Masks and respirators that are designed and sold as personal protective equipment (PPE), and thus focus on protecting the wearer, fall under the scope of the PPE Directive.
Protective masks and respirators, such as FFP2 and FFP3, mainly fall under category III of the Directive, as they are designed to protect against substances that are dangerous for the health of the wearer.
You can learn more about PPE classification in Annex I of the official the Directive.
PPE Lab Testing
To ensure your PPE products are safe and secure for the users, importers have the legal obligation to conduct the test or obtain the test reports from the suppliers. Third-party lab testing can help you to verify the product compliance in the EU, and issue official test reports and certificates specifically for your products.
EN Harmonized Standards
EN standards are the key component when importing products into the EU. For non-medical use face masks, there are EN standards that explain the requirements and testing procedure to establish compliance of your products.
Here we list some applicable EN standards for protective face masks:
- EN 143 – Respiratory protective devices — Particle filters — Requirements, testing, marking
- EN 149 – Respiratory protective devices — Filtering half masks to protect against particles
Depending on the type of face masks, importers can find additional applicable standards on the EU official website.
PPE Testing Companies
Leading test companies such as Bureau Veritas, Intertek, SGS, TUV, and others, can provide compliance service, such as lab testing and more, for face mask compliance.
Notified Body
For PPE that is classified in category II or III of the Directive, an assessment carried out by a notified body, which will also have to issue the Certificate of Conformity, is also necessary. The lab testing companies mentioned above can also act as notified bodies.
CE Marking
Since both the MDD and the PPE Directive are CE marking directives, importers must also comply with the CE marking requirements. In particular, the CE mark shall be permanently affixed in the product – as long as the nature of the product allows affixing the mark, – packaging, and documentation.
CE label file
The manufactures are not obligated to provide the CE label files for your product, nor to ensure that the CE mark dimension and shape are correct. Therefore, you shall provide digital CE label files preferably in .ai or .eps format. Also, you shall specify the following:
- Dimensions
- Position
- Color
- Print type
- Notified body identification number (if a notified body is required)
Note: You shall also include the CE mark in the user manual files or wherever applicable.
Product Traceability
The traceability code is also required for CE compliance. The code shall be affixed on the packaging, and disclose information such as:
- SKU
- Manufacturing date
- Production facility
- Country code
Example: SKU-1811-01-CN
Certification and Documentation
The CE mark is only one of the steps to comply with any CE directive. Importers also need to issue documents such as the Declaration of Conformity (DoC), user manual, technical files, and test reports.
Declaration of Conformity (DoC)
The DoC shall be issued by the importer or manufacturer to provide product information as follow:
- Produce identification/SKU (e.g. Face Mask C19)
- Product features
- Manufacturer/importer contacts
- List of applicable EN standards or directives (ie. EN 149)
- Manufacturing location
- Responsible individual
The DoC is often required by government bodies, retailers and even consumers, in order to confirm the CE compliance.
User Manual
Importers shall also create a user manual, which might include information such as:
1. How to use the face mask properly
2. Product materials and filter capacity
3. Potential hazards related to the face mask
4. How to dispose of the face mask properly
Technical File
The technical file is somewhat similar to the product specifications sheet. Importers shall include all relevant design, material, labels, packaging and other relevant files in the technical file. Here are some examples for your reference:
- Bill of materials
- Design drawings
- Label files
- Packaging files
- List of applied standards and directives (e.g. EN 14683)
- Test reports
- QC reports
- Risk assessment
Test Report
Lastly, the test reports are essential to demonstrate the compliance of the face mask. All relevant test reports shall be provided corresponding to the EN standards and directives as stated in the DoC.
Other Regulations
REACH
REACH is applicable to all products sold in the EU, including face masks. Hazardous substances, heavy metals, and pollutants are regulated under the regulation. With that said, imported face masks shall not contain excessive amounts of restricted substances.
Directive 94/62/EC: Packaging Regulations
The packaging of the face mask is also regulated in the EU. The packaging material shall not include hazardous substances such as lead and mercury which can be found in the part of printing inks and dyes.
In addition, third-party companies such as SGS, TUV, and Intertek provide packaging materials testing services to verify packaging compliance in the EU.
If medical face mask, type IIR, was manufactured at 08/2020, and it is in compliance with MDD (packaging and Declaration of Conformity), is it possible to import it from UK to Germany?
We are a Japanese Manufacturing of Non Woven Surgical masks based in Philippines, How can we able to sell our product in any EU country
“Product Registration
Your face masks shall also be registered within the relevant authority in the EU country where either your company or your authorized representative is based”
Hello!
Which document describes this requirement?
I wanted to know if a the FFP2 mask has the CE marking and the Module B certificate – is it enough for importing or Module C2/D is mandatory?
if n95 mask with filter loose fitted with ultra violet and mask should be transparent with these specifies n95 still lie in class 1 or 2 in EU regulations
Great post! Many thanks!!
We have an important question, we wanted to ask you a question because we have doubts as to whether the information you indicate faithfully follows the regulations or if we are wrong.
We want to import FFP2 NR masks and we have all these documents from the manufacturer:
– EU-TYPE EXAMINATION (MODULE B) CERTIFICATE
– CONFORMITY ASSESSMENT MODULE C2 CERTIFICATE
– TEST REPORTS (FFP2 NR Passed)
We are missing the Declaration of Conformity.
Here comes our question:
You say: “Importers also need to issue documents such as the Declaration of Conformity (DoC), user manual, technical files, and test reports.”
Also, In another of your posts you say: “Are importers responsible for issuing the DoC?
The DoC can either be issued by a manufacturer or an importer.”
As far as we know, an EU declaration of conformity (DoC) is a mandatory document that the manufacturer or the authorised representative need to sign to declare that your products comply with the EU requirements: https://europa.eu/youreurope/business/product-requirements/compliance/technical-documentation-conformity/index_en.htm#shortcut-3
And again, as far as we know, an Authorised Representative (AR) does not have the same role as the importer. An AR is a legal party based in the European Union that acts as a liaison between a manufacturer outside of the EU and competent national authorities within the EU.
We do not know if what this Factsheet for Authorized Representatives, Importers and Distributors of medical devices is applicable only for medical devices or also for PPE.
https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/importersdistributors_factsheet_en.pdf
It says that An authorised representative means any natural or legal person established within the European Union who has received and accepted a WRITTEN MANDATE from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the Regulations.
Arrived here, our questions are the following:
Can the importer issue the Declaration of Conformity unilaterally by himself?
Or does he have to receive a prior written mandate from the manufacturer making him his Authorized Representative?
In this case, could the same company be the importer and the authorized representative of a manufacturer (issuing the Declaration of Conformity)?
Many thanks for your time!!!
Please just a clarification regarding the 3 ply civilian non-sterile masks.
Is the CE mark issued by a notified body necessary to import and distribute non-sterile 3 ply masks for civilian use in Europe?
Thank you
Disposable Protective Respirator (EN ISO 14683) Type IIR non-sterile require a Notified body for import?
Hello, do this requirements apply the same for manufacturers as well?
Really good guide, would you want to write a similar one for gloves? :D
Thanks Alex!
We might do so in June. Still working on our content schedule for the summer.
What is the requirements for woven fabric masks.
Do Type IIR masks need a CE mark assuming they have passed all tests?
EN says the requirements on the packaging are ‚only‘:
Both the Medical Device Directive (93/42 / EEC) and the Medical Device Regulation (EU) 2017/745 specify the information that should appear on the packaging in which the medical face mask is supplied.
The following information must be provided:
a) number of this European Standard;
b) Type of mask (according to the information in the table).
Follow-on question:
Are Type IIR masks even allowed to have a CE mark?
Does FFP2 needs EN149 regulation to enable to be sold in the EU.
Can we know a authority responsible for tracking products sold in the market on Fake Documents.
You need a Nando Database test lab ceritificate. This can be check on the EU Nando Database. Make sure to also check the underlying categories depending on the product, ie if a mask they also have to be allowed to do mask testing. i.e. the lab may be in the Database but only certified to do goggle testing.
Most labs will have searches for certificates to check their are genuine on their website but you need to check if they are a genuine lab allowed to do these Tests and issue certificates. At the moment there are a lot of ECM (Italian Group) certificates around. They can be found on their website but the problem is ECM is not even allowed to issue these since they are not in the Nando Database.