When researching the purchase of surgical or respirator facemasks, it is hugely important to ensure that they are manufactured to EU standards. At the beginning of the pandemic there were limited supplies available. But now there are now thousands of companies making disposable facemasks. From a shortage to a surplus! However, a lot of that surplus, particularly those at the cheaper end, are not manufactured to the requirements needed for European sale or distribution in medical settings.
What are the EU standards for surgical facemasks?
MDR – European Medical Device Regulation
The EU MDR regulation was created to improve the safety and performance of medical devices in Europe. The intention is to provide a high level of protection for the health of patients and users of these medical devices.
MDR has set up a unique device identification (UDI) system that is similar to that used by the US Food and Drug Administration (FDA). If a company intends to provide or distribute medical devices into the EU marketplace, the labelling needs to comply with this UDI system. In summary, it means that each batch is traceable and has an expiry date.
- Compliance with the new MDR regulation is mandatory for medical device companies that intend to sell products in Europe
- All face masks sold in Europe MUST conform to this regulation since May 2021. Not all do
CE certification
CE certification is indicated by a CE Mark
- In order to apply the CE Mark, in addition to the MDR, a company must also have a Quality Management System (QMS). Irema complies with ISO 13485 and 9001
- Irema’s CE mark means that the product has been tested to ensure the minimum filtration efficiency
- EN 14683: Irema’s Type II and IIR surgical masks the BFE is ≥98%. It also covers differential pressure (breathability), splash resistance and microbial cleanliness
- Irema’s masks made in Thailand and Ireland are MDR and ISO certified with a CE Mark
What are the EU standards for respirator face masks?
Respirator masks must follow similar EU regulations. Irema N95 masks are NIOSH certified and FFP2 and FFP3 meet CE EN149 standards.
FFP2 respirator masks filter ≥94% of bacteria, N95 masks has a BFE of ≥95% and FFP3 have the highest possible protection with ≥99%.
Cloth masks
It’s important to note that washable and reusable cloth masks, whilst being significantly better than no mask, filter less than half that of surgical masks. Recent research reported by CNBC suggests it’s as little as 37%.
Irema masks are all made to EU and International standards. You can view Irema certificates on our certification web page.
Irema face masks for personal use can be bought on StaySafe. Larger quantities should be ordered directly from Irema or through your local healthcare distributor.
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