Facing the COVID-19 outbreak, EU Member States, as well as other countries worldwide, are facing the lack of protective equipment. On the other hand, many companies may have the means to manufacture these high-demanding products, but do not know how to assure compliance and place them on the market. This article will give an overview of the respective EU legal frameworks as per the Commission Guidance.
1. Applicable EU legal framework for placing the protective equipment on the market
In most cases, Regulation (EU) 2016/425 on personal protective equipment (PPE)is going to be applicable. However, the products you are placing could also fall within the Medical Device Directive 93/42/EEC (MDD).
This will depend on the type of the product you intend to place on the market and its main function: i.e. intended use and mode of operation.
For example, one of the most popular products are face masks, gloves, coveralls and FFP-type masks. Their intended use is to protect against airborne particles and droplets, so they fall under the scope of the PPE Regulation.
However, surgical masks and medical gloves intended for doctors, nurses and other specialists, products dedicated to intensive care units, or any other product that has a medical purpose, will fall under the scope of the Medical Device Directive.
2. EU standards to be followed by manufacturers
Both PPE and MDD are technologically neutral and do not prescribe a mandatory solution for product design or materials. Furthermore, both frameworks only lay down essential requirements.
However, PPE and MDD both present an opportunity for manufacturers to rely on the harmonized standards. European harmonized standards are owned by the European standardization organizations and must usually be purchased. However, standards have been made public earlier this year, as an official step to accelerate the production of protective products in context of the COVID-19 outbreak. 14 standards can be downloaded for free from the online catalogues of the national standardization bodies. A full list is available at the following link. Fastest way to place products on the market would be by adopting harmonized standards.
The harmonized standards for face masks are EN 149:2001+A1:2009 for the FFP-type masks and EN 14683:2019 for surgical masks.
3. Other standards that can be followed
European harmonized standards are the most popular solution in the EU industry, however, there are other technical solutions with similar results.
The most notable are the World Health Organization guidelines on the choice of protective equipment. However, if the product falls within the scope of PPE, a sample should be tested by a Notified Body, for which the EU Commission issued a Recommendation to accelerate the entrance of new products on the EU market in the context of the COVID-19 outbreak. The Notified Bodies’ attention was drawn to the fact that the WHO guidelines could present alternative technical solutions that are as adequate as EN standards.
4. Authorization/certification to be performed prior the placing on the market
MDD does not require that manufacturers attain the CE Certificate for Class I devices. Surgical masks and medical gloves are commonly classified as Class I; therefore, manufacturers should be able to place those products on the market by self-certifying their devices, without including the Notified Body.
Face masks and other PPE equipment mostly used in the COVID-19 context are usually considered as ‘PPE of Category III’. In this case, a Notified Body must be involved. Manufacturers can start placing PPE products on the market only after a sample of the product has been assessed and tested. Additionally, products are inspected at random intervals or through similar control procedures.
5. CE marking
According to both legal frameworks, the CE marking should be affixed on each individual product.
22.04.2020
Nika Gavrilovic
Regulatory Affairs Department
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