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Due to the coronavirus outbreak, the demand for medical use masks in the Netherlands is still large. Although there is a growing supply of masks that can protect against the coronavirus COVID-19, the distribution has not reached all care sectors yet. If you want to produce face masks for medical use in the Netherlands, your product has to meet stringent product requirements.
Which masks are used in the healthcare sector?
Two types of face masks are in use in the Dutch healthcare sector:
- Respirator masks, FFP1, FFP2 or FFP3 standard: these close-fitting masks are intended to protect the care provider. They are worn when performing high-risk treatments, for instance in Intensive Care (IC).
- Surgical masks: these masks are used for the protection of the patient. In some cases, they may now also be used to protect the care provider. You can read which type of face mask can be used in which situation in the Rijksoverheid factsheet (in Dutch) ‘Which face mask is required when?’.
FFP1, FFP2 and FFP3 standard face masks
Respirator masks come in 3 protection classes: FFP1, FFP2 and FFP3. FFP2 and FFP3 masks are Personal Protective Equipment standard masks.
Face masks can only be used in healthcare if they meet stringent requirements. These requirements are described in standards, that are managed by the Dutch standardisation institute NEN.
- Respirator masks must comply with the EU standard NEN-EN 149. The SZW Inspectorate monitors that this standard is observed.
- Surgical masks must comply with the EU standard NEN-EN 14683. The Health and Youth Care Inspectorate monitors that this standard is observed.
Masks without CE marking temporarily allowed
Due to the coronavirus outbreak, it is temporarily allowed to bring face masks without CE marking onto the market. Companies can make use of a fast-track test procedure with a notified body.
Register your product at the Landelijk Consortium Hulpmiddelen
Resellers, suppliers, importers, and manufacturers can register face masks for medical use at the LCH (in Dutch), the national consortium for medical help devices. The LCH is an initiative of the Ministry of Health, Welfare and Sports, hospitals and medical help devices suppliers. Medical devices are purchased and checked jointly.
RIVM guidelines for the use of face masks
In the Netherlands, only medical personnel wears EU standard face masks, on the advice of the National Institute for Public Health and the Environment (RIVM). From 1 June, people using public transport have to wear ordinary face masks, that they can buy or make themselves (here is an instruction). Face masks only function well if they are used correctly. They have to fit tightly over mouth and nose, and they must be replaced regularly. Using face masks incorrectly can give people a false sense of security. Read more about the correct use of face masks on the RIVM website (in Dutch).
Producing face masks: check existing patents
If you want to produce face masks, you can use the knowledge from existing patents (RVO news item, in Dutch). You can view patent applications in the patent database Espacenet free of charge. You can ask for a patent advisor's help browsing the database. If a patent is registered in the Netherlands, you cannot copy it or sell it without permission. That is a breach of patent law. If a patent is registered in other countries than the Netherlands, you can copy it for use on the Dutch market. A patent is valid for a maximum of 20 years. After that, you can also use a Dutch patent for your own product.