Due to the COVID-19 crisis, the demand for face masks has increased tremendously, especially now governments lift lockdowns and start advising their citizens to wear face masks in public, to help prevent the spread of the virus.
Are you thinking of importing Face masks into the European Union?
First, you need to know how to meet the European Regulations for Face masks, what are your challenges? And how do you ensure that the masks comply to the European Regulations? What are the differences between the different kind of masks? In this blog you will find practical information about types of face masks, which EU law will apply, comply with EU legislation, your role in the supply chain and CE mark the mask yourself. If you still have questions or need support after reading this blog, Qserve could support you with getting your product on the EU market as efficiently as possible.
Types of face masks
Face masks typically fall into one of two categories — medical or respirator.
- Medical (including surgical) Masks, intended to prevent that the user spreads infectious agents, like viruses and bacteria. These masks are considered Medical Devices (MD)
- Respiratory protection Masks are intended to protect the user from inhaling aerosols (dust, smoke mist), vapors and gases or airborne infectious agents such as COVID-19. These masks are considered Personal Protective Equipment (PPE)
Which EU law will apply?
Depending on the type of mask different EU regulations will apply. In Europe, all PPE and MD products are required to hold a CE mark. PPE Masks are regulated by the EU Personal Protective Equipment Regulation 2016/425 (PPER). The EU Medical Device Directive 93/42/eec applies to medical /surgical masks (MDD). The MDD is to be replaced by Regulation (EU) 2017/745 as from 26 May 2021 (MDR).
Both the PPE Regulation and the Medical Device Directive set essential requirements on health, safety and performance of the products they cover. Masks can also fall in both categories if they are intended to protect the patient AND the user. In these cases, the product needs to comply with both regulations. They have a dual CE mark.
How do you ensure your masks comply with the EU legislation? The Medical Device Directive set requirements for medical masks such as testing, classification, safety and performance. And the same counts for the Personal Protective Equipment Regulation.
Medical Masks: Risk class and conformity assessment
Medical masks are ‘Class I Medical Devices’. As such, they do not require the mandatory involvement of a Notified Body (third party testing body). The manufacturer must ensure and certify that the product complies with the applicable requirements. This regime is essentially one of self-certification. If the medical masks are sterile, the product is classified in a higher risk class (Class IS) and a conformity assessment by a Notified Body is required, prior to placing the product on the EU market.
EN 14683 Harmonized Standard
Manufacturers can use harmonized standards to demonstrate that product complies with the MDD or MDR. In the case of medical face masks, EN 14683:2019+C1:2019 ‘Medical face masks - requirements and test methods’ is used to demonstrate compliance.
Medical masks shall be tested to ensure that these essential requirements are met. The tests prescribed can be performed by the manufacturer himself but preferably by an accredited laboratory. EN 14683 distinguishes two types of masks (Type I and Type II), according to bacterial filtration efficiency. Type II is further divided according to whether the mask is splash resistant. The ’R’ signifies splash resistance.
PPE Masks: Risk class and conformity assessment
PPE masks fall in the highest risk category (category III) of the PPER and require EU-Type examination by a Notified Body, including production controls and/or Quality management system audit.
EN 149 Harmonized Standard
EN 149:2001+A1:2009 specifies the minimum requirements for filtering half masks used as respiratory protective devices, specifically against particles, and the required laboratory and practical performance tests to assess the compliance of the masks. EN149:2001 classified half masks into three types according to their filtering capacities (e.g., FFP1, FFP2, and FFP3). It is mandatory for all products to be tested in accordance with EN149:2001 to provide protection against solid and liquid aerosols. FFP1 masks block ≥80% airborne particles, FFP2 ≥94% and FFP3 ≥94%.
Face mask Testing Laboratories
Manufacturers can contact the laboratories to test the face masks. These laboratories are accredited for the scope EN 14683 and / or EN 149.
What's your role in the supply chain?
In any case you will have to consider your role in the supply chain. Be aware if you put your name on the label, you might be considered the manufacturer, who is responsible for CE marking and compliance. If you chose to be the importer, who is importing a product that is already CE marked by a non-EU based manufacturer? Then your responsibilities are more limited. But check if all obligations are fulfilled by the manufacturer. Is the CE certificate available for the product or proof of registration, test reports, Declaration of conformity? Is a EU authorized representative appointed (for medical devices).
Consider your role upfront! Especially the case when you intend to private label a product and hence become by default the legal Manufacturer.
What if you want to CE mark the masks yourself?
If you want to market the product yourself under your own name or trade name, you need to meet the following requirements as the manufacturer of the product:
- Have full technical documentation for the product including test reports.
- If you contract the production out, you need to have a regulatory contract in place with the Producer in which certain obligations for both parties are defined.
- If you are a manufacturer outside the EU, then you need to establish a contract with an Importer in the EU and with an EU Authorized Representative.
- For PPE masks, a two-stage conformity assessment procedure must be followed. Upon successful completion, the notified Body issues a CE Certificate.
- For Class I medical and surgical masks, no Notified Body is involved, except for sterile masks.
- You then issue a Declaration of Conformity (self-declaration) and may apply the CE Mark on the product.
- Registration of medical devices in Member States of the European Union
Once you have applied the CE Marking and appropriate CE Certificates, if required, are issued by the Notified Body, medical face masks need be registered within the relevant authority in the EU country where either your company or your authorized representative is based. Some EU countries require the registration of medical devices their national databases. Each Member State might have a different process to go through and slightly different requirements.
Do you need support?
Contact Qserve. Qserve may offer you support in regulatory compliance and conformity assessment or registration of medical devices in the various Member States and can carry out this activity for you.
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