Shipping 101
How to Pass CE Certification for Surgical/ Medical/ N95/ Disposable Facemasks

How to Pass CE Certification for Surgical/ Medical/ N95/ Disposable Facemasks

If the CE Certification you have is not recognized by the EU, you won’t be able to get your product through customs!

4 mins, 1 Apr 2020
How to Pass CE Certification for Surgical, Medical, N95, and Disposable Face Masks
Bookairfreight’s Key Takeaways:

• CE Certification is a MUST for goods that are imported from China into the EU, face masks very much included!

• A qualified, or a noted agency must grant the CE certification in order for the goods to pass through customs in the EU.

• Any organization that gives out CE certification needs to meet the requirements as listed in the EU Classification in order for the EU to recognize them.

As an e-commerce store owner, it seems like the list of things to keep in mind for running your business never ends. Handling customer issues, handling supplier issues, handling employee issues, and of course the Coronavirus situation to top it all off can be overwhelming.

Unfortunately, one blog article won’t solve all of these problems for you! But if you ship goods to Europe, you’re going to have to understand CE Certifications. Put simply, products that are properly CE certified comply with EU legislation for health and safety.

If the CE Certification you have is not recognized by the EU, you won’t be able to get your face masks through customs!

Not to worry though. After reading this blog post, you’ll be able to easily identify whether your manufacturer has valid certification, saving you time and money going through customs.

How Can I Make Sure My Manufacturer’s CE Certification Is Valid?

If you’re importing products from China into the EU, CE certification is a must. But working with external suppliers, how can you tell whether your sourced face masks meet this requirement?

The CE certification process involves multiple parties, and has been a really confusing process for Chinese companies to navigate.

Today, many unqualified intermediary agencies use Chinese factories’ lack of understanding of EU regulations to mislead them into making wrong choices. This in turn makes their CE certificates invalid, which causes huge risk for enterprises.

This is not to say that the certificates are fake, just that EU customs won’t recognize them. Think of it like a driving license - you can’t drive in China with an American license.

Fortunately, with a simple internet search you can quickly find out whether or not the agency that certified your manufacturer’s company is recognized.

How Does the EU Classify My Item?

For whatever product you’re importing, you can find its EU Classification in this website: https://ec.europa.eu/growth/sectors.

Find the matching industry, and from there you can find the type of product. Then you’ll be able to find the requisite regulations. As an example, protective face masks (N95 respirators, surgical masks), fall under (EU) 2016/425 PPE.

Choose the industry that your product falls under:

How Does the EU Classify My Item?

What are the Required Procedures for My Item?

When you have the item’s classification number, you’ll want to research the required procedures around it. This is pretty easy to do by Googling the classification number + procedures.

So going off of our face mask example, it falls under (EU) 2016/425 PPE regulations, and by Googling “2016/425 PPE procedures”, we found this document.

This tells us we’ll need Module B and Module C2 and/or Module D, which comes out to one of:


1. Module B (type inspection certification) + Module C2 (internal quality control + random inspection of product)

2. Module B + Module D (quality control during production process)


How Do I Know if My CE Certification Will Pass EU Customs?

We’re almost there! We have the classification and the required procedures. Any organization that gives out CE certification (including for face masks!) needs to meet these requirements in order for the EU to recognize them.

You can find out if a company is a proper Certification agency in just three steps!

Step 1: Check the official EU website for information on notified bodies

First, we’ll start on the Notified bodies for single market and standards website: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main

Search for the organization that certified the goods on this site:

how to verify CE


Step 2: Check if the body has the regulation authorization

Once you’ve found the certifying organization, look in the Legislations section and see whether your goods classification is there.


Here is an example of an organization that has authorization for certifying protective equipment like face masks.

Look for your regulation under "Legislations":

CE Certified authorization

If that regulation is not there, the agency has no recognized authority to certify this type of product.


Step 3: Does the organization follow the required procedures?

Once you’ve found the certifying body and checked that it is authorized under the necessary regulation, click on the “HTML” or “PDF” link next to the authorization. You’ll see a list like this:

Check that your product and necessary procedures are covered:


CE Certified products

You want to make sure the following are true:

1. The product type is under Products

2. The authorized procedures are under Procedures.


If your authorizing body does not have this information under their company’s profile, the certificate is not valid and you will have issues importing your face masks. Be very careful in checking this!

So, to sum it all up, here's how to pass CE Certification for face masks

1. Find the EU Classification Number for your product, under the appropriate industry at EU Growth Sectors.

2. Do a Google search for the following format: “Classification Number + Procedure”. For example: for masks search “2016/425 PPE procedures”

3. The search result needs to lead you to a document containing details on Module B and Module C2 and/or Module D - which list the inspection or quality certificates that an agency granting CE Certification must have.

4. Check the official EU website for information on notified bodies here: EU Notified Bodies

5. Check if the body has the regulation authorization - it should have your product’s classification number.

6. If the regulation is not there, the agency has no recognized authority to certify this type of product.

7. Lastly, you need to check if the organization follows the required procedures that you found in step 3.

Putting It All Together

Now you can validate any of your manufacturers’ CE certifications for face masks and any other products! We know the entire process can be really tricky, and getting any step wrong could mean days of delay and thousands of dollars in costs.

We’ve helped many customers ship regulated goods from China to Europe, so feel free to email us at bookings@bookairfreight.com with any questions.

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Rajitha Reniguntla

Rajitha Reniguntla is a supply chain enthusiast from Hong Kong. With a curious mind, she's an avid learner carrying a knack for exploring and breaking down complex ideas. She loves to learn about new things and always aims to enhance the customer experience. Outside of work, she enjoys cycling, doodling and listening to podcasts!

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