On 8 May 2020 Caspar ter Horst from ProductIP and the Dutch Chamber of Commerce (KVK) have written an extensive article (link) on the import and distribution of surgical masks, respitory devices and handgels. The tekst is written for the Dutch market, however relevant for the entire EU market. Below you will find the translation in English, relevant for the EU market.
The Netherlands suffers from a great shortage of medical masks and disinfectant handgels. Through (foreign) networks you will find parties to fill these shortages. What requirements must personal protective equipment meet? And what obligations do you have when you bring these products onto the market? Want to learn more after reading this article? ProductIP has released a guidance document for 'medical masks' and a guidance document for 'handgels'.
In this article the following subjects will be covered:
Products must always meet the applicable product requirements. This is no different for personal protective equipment. Requirements may vary from product to product. Import and distribution of maks and disinfectant handgels has a number of rules that you have to take into account.
Product requirements apply to products you put on the market in the European Economic Area (EEA). These requirements are European safety, health and environmental requirements. The EEA consists of the EU, Norway, Iceland and Liechtenstein. Many products must meet the requirements of CE marking. These requirements are listed in the applicable European directives and regulations. The manufacturer must take a number of steps before he may apply CE marking to his product.
Caspar ter Horst, director of ProductIP, helps companies to comply with product regulations for non-food products. "This comes very precisely. You soon have to deal with different legislation pieces. This also applies to medical surgical masks, filtering half masks and handgels. You have to be able to demonstrate that your products comply with all legal regulations”.
Users of medical surgical masks protect their environment (e.g. patients) against possible contamination. These oral caps fall (still) under the European directive for medical devices. This directive will be replaced by the European regulation for medical devices as of 26 May 2021. The regulation would take effect one year earlier, namely on 26 May 2020, but due to the corona crisis the entry into force has been postponed by one year.
Surgical masks are self-certified. This means that the manufacturer may assess (or have assessed) whether the surgical masks meet the requirements for CE marking. This is called conformity assessment. If the product meets the requirements, the manufacturer draws up a signed EC declaration of conformity (DoC) and a technical construction file.
The importer assesses this file and has a copy of this information available for questions of the supervisor (Health Care and Youth Inspectorate). The product states who the non-EU manufacturer is and who the EU importer is. If it only states an EU address, then that party is considered to be a (quasi) manufacturer. The EC declaration of conformity must then be drawn up and signed by this party.
Is the product a sterile surgical maks? Then there's no self-certification. In this case, an independent Notified Body must test whether the sterile oral caps comply with the regulation for medical devices. Behind the CE logo there will be a 4-digit code of the Notified Body in question. A Notified Body is a designated laboratory within the EU.
As an importer of masks manufactured outside the EEA, you always have a legal imposed responsibilities. For example, check that the manufacturer has carried out the conformity assessment correctly, that the CE marking has been (correctly) affixed and that instructions for use (instructions, safety information) are available in the correct language. Also check the presence of the technical construction file and retain the manufacturer's EC declaration of conformity.
Do you buy from a manufacturer or importer within the EEA? Then check if the CE marking has been affixed, that the EC declaration of conformity is present and that user instructions (instructions, safety information) are available in the correct language.
Attention: Do you import products from abroad and would you like to market them under your own name? Then you take over the role and obligations of the manufacturer.
The sale of medical products must always be reported to the designated authority in the EU Member State. In the Netherlands this is Farmatec. In 2021 you will report this in a central European database (EUDAMED).
The European standard EN 14683:2019+C1:2019 is relevant for the production of surgical masks. A standard describes how a product, in a technical sense, can meet (one of) the essential requirements in a ‘CE directive’. As an importer, check whether your products are made in compliance to this standard. You can find the standard on the website of the nationals standardisation organisations, in The Netherlands: NEN (temporarily available free of charge). See here the list of National Standardization Bodies (NSBs).
An important additional requirement is that the manufacturer's quality system must be certified in accordance with ISO 13485. Packaging and instructions are in the national language, and the product is marked with CE.
Respiratory protective masks with filter are covered by the European Regulation on Personal Protective Equipment (PPE). These masks are referred to as FFP1, FFP2 and FFP3 masks. These are different classifications. FFP1 and FFP2 masks are often used in healthcare.
The manufacturer must ensure that masks comply with the requirements of the PPE Regulation. In this case it is mandatory that a Notified Body tests the products. A Notified Body must also release each batch. This can be done either per batch or via a certified quality system. Furthermore, the manufacturer must draw up and sign the EC declaration of conformity (DoC0 and refer to the approval of the Notified Body. The manufacturer must also draw up technical documentation. Packaging and product are given a CE marking followed by 4 digits, this is the code that belongs to the Notified Body in question.
Attention: There are false declarations of conformity in circulation that supposedly originate from Notified Bodies. The European branch organisation of companies that are active with personal protective equipment keeps an overview of this.
As an importer, do you market the masks under your own brand name? Then you take over the above obligations from the manufacturer. Obligations of the manufacturer, authorised representative, importer (of products outside the EEA) and distributor (of products within the EEA) can be found in the text of the PPE Regulation.
The relevant standard for these masks is EN 149:2001+A1:2009. The standard can be found n the website of the nationals standardisation organisations, in The Netherlands: NEN (temporarily available free of charge).
Handgel falls under the Biocides Regulation and/or the Cosmetics Regulation. Although there is no 'CE-regime' you do have a number of obstacles to overcome.
Biocidal products contain active substances that control harmful organisms. Biocidal products may only be sold in the EU if the active substance and the finished product containing the active substance have been authorised by a Member State. Disinfectants such as a hand gel with, for example alcohol (ethanol) as the active substance are biocidal products. If you are an importer of this kind of handgel and want to sell it on the Dutch market, then you must apply for authorisation from the Board for the Authorisation of Plant Protection Products and Biocides (Ctgb). Even if it has already been authorised elsewhere in the EU, you must apply to Ctgb for authorisation to sell it in the Netherlands.
Do you want to bring handgel on the European market with a new active ingredient? Then apply for authorisation from the European Chemical Agency (ECHA). This is a long route. It is better to make use of existing authorisations of active substances and production companies that are already registered. Only companies that are on the Article 95 list of the Biocides Regulation are allowed to produce biocides or active substances. If you buy your private label from these companies, you still have to register your version of the product with the authorities in each Member State.
It is possible that the Cosmetics Regulation (also) applies to your products. In that case, other rules apply. That is why it is important to know whether your product is a biocide or cosmetics.
Ter Horst emphasises: “Accuracy is always necessary, and now certainly, if you want to import and trade surgical maks, respiratory devices or handgels. This applies to everyone in the product chain.
Are you a retailer or do you have an eCommerce platform? In that case, too, you need to verify that the supplied substantiation is correct, that the correct registrations have been made, and that the texts on packaging and product are correct and in Dutch".
The European Commission has arranged that governments may temporarily offer to manufacturers and suppliers the opportunity to supply medical devices and personal protective equipment destined for healthcare that do not have a CE marking. This is due to shortages caused by the coronavirus outbreak. However, certain conditions apply.
A European Directive (85/374/EEC) protects consumers against damage caused by defective products. This includes personal injury (damage caused by death or bodily injury) and property damage (damage to another consumer's product caused by the defective product). You can insure against the risk of product liability. Discuss the possibilities with an insurer.
Product liability works differently within and outside the EEA.
As an importer, you retain the responsibilities mentioned in the European CE directives and regulations.
Importing branded products outside the official distribution channels is called parallel import. You do not buy the branded product from the official foreign manufacturer or official importer. But, for example, from a foreign intermediary. Would you like to import masks or handgrips of a well-known brand from countries outside the European Economic Area (EEA) via parallel import? This is only allowed if you have permission from the trademark owner. The trademark owner has the right to be the first to put a product on the market in the EEA. The trademark owner is usually the official manufacturer.
Has the product been put on the market within the EEA for the first time by the trademark owner (or, with his consent, by someone else)? Then it is then freely marketable within the EEA. The right of the trademark owner is then exhausted. From that moment on you may buy the trademark product in another EEA member state via parallel import. When importing products via parallel import, you still have to deal with the applicable product requirements. Furthermore, it is punishable to import and trade in counterfeit goods.
Not every provider of personal protective equipment is reliable. The Dutch Chaber of Commerce (KVK) has received reports of fake websites offering mouthpieces and other hygiene products. Criminals misuse data from existing companies for this purpose, but change the bank account number. The (down)payment that you then make when placing an order, comes straight into the hands of internet criminals, who profit from the high demand for and the inadequate supply of these products. This is only 1 example of business identity fraud. You can already do a number of checks yourself to check whether the foreign supplier is who he says he is.
Be alert for false declarations of conformity that supposedly originate from Notified Bodies. The European branch organisation of companies that are active with personal protective equipment keeps an overview. If you come across false documents, warn the Notified Body. It is also good to inform the applicabal national authority for Product Safety if you see that false documents are being offered. The marketing of products on the basis of falsified substantiation is fraud and forgery. If this also results in personal injury or worse, criminal prosecution will follow.