Conformity assessment procedures: Adaptations to COVID19

COVID-19 is a highly infectious disease that is spread from person to person mainly through the droplets produced when someone infected speaks, coughs or sneezes. It is everyone’s responsibility to work towards the goal of reducing the spread and help contain the pandemic.

Among the Commission’s top priorities are safeguarding the health and well-being of citizens and it will use all of the tools at its disposal for this purpose. This is why it is working to take all necessary steps and coordinating with Member States to facilitate the supply of protective and medical equipment across Europe.

One of the major hurdles met by governing authorities all across the globe is the sudden surge in demand for this equipment. The demand for personal protective equipment (PPE), namely face masks, gloves, overalls and eye protection equipment, as well as for medical devices (MD) such as surgical masks, medical examination gloves and some types of gowns and community masks, increased exponentially in a very short amount of time, straining the existing supply chains.

Faced with this challenge, new strategies and approaches are needed to ensure that the most appropriate PPE and MD are swiftly made available, ensuring adequate protection to those who need it most.

The effective endeavor of meeting this challenge has been taken by the countless economic operators, active across the EU, that are working relentlessly to increase their respective manufacturing and distribution capacity. In order to mitigate the effects of the various disruptive factors introduced by the pandemic, these economic operators are being forced to redesign their supply chains by launching new manufacturing lines and/or diversifying their supplier base.

This surge on industrial and productive output had to be met by an expansion of the ability to regulate and accommodate the production. On March 13, 2020, the European Commission published a Recommendation (Commission Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat), to facilitate the rapid uptake of new products on the EU market and thus help fight the coronavirus outbreak.

A key part of this effort is to ensure that all the participants in the productive supply chain know the requirements needed.

- Products such as disposable or reusable masks - including FFP masks, coveralls, disposable or reusable eye protection gloves and equipment - are considered as PPE and are covered by Regulation (EU) 2016/425 of the European Parliament.

- Products such as medical gloves, surgical masks, some types of gowns, intensive care equipment and other medical equipment, are considered to be MD and are covered by Council Directive 93/42 / EEC which will be replaced by Regulation (EU) 2017/745 as from May 26, 2020.

Each of these regulations outline the minimum requirements applicable that ensure the protection of the health and safety of users. This means that products manufactured in accordance with these rules can then circulate freely throughout the internal market, and that Member States cannot introduce additional diverging requirements with regard to the manufacture and market placement of such products.

Before placing PPE and MD on the market, manufacturers must demonstrate, through an appropriate procedure, that they can comply with the applicable health and safety requirements so that they can affix the CE marking. However, it is important to note that these regulations are technologically neutrals and do not provide specific mandatory technical solutions for the design of PPE or MD. It is up to manufacturers to come up with the specific technical solutions. Despite that, in an effort to help speed up production, harmonised standards are published that outline the technical solutions that are avowed by the regulatory authorities. These harmonised standards are a specific category of European standards, developed by a European standardization body, which describe the technical specifications considered adequate and sufficient to ensure compliance with the technical requirements set out in European legislation.

In cases where the manufacturer decides to adopt these technical solutions, it is assumed that the product already complies with the applicable requirements. Details of these harmonised standards have been published in the Official Journal of the European Union.

  • In the case of FFP type masks, the harmonised standard is EN 149: 2001 + A1: 2009

  • In the case of surgical masks, the applicable standard is EN 14683: 20019.

In order to ensure that the European Industry can quickly respond to the increase in demand, the Commission and the European Standardization Organizations agreed that the relevant European harmonised standards will exceptionally be made freely and fully available for all interested companies. This action will help both EU and third-country companies to manufacture these items without compromising on health and safety standards and without undue delays. However, compliance with the harmonised standards is not mandatory and manufacturers can adopt different technical solutions if they wish to do so. The World Health Organization (WHO) guidelines on the choice of protective equipment can provide a helpful reference in that respect.

Nevertheless, compliance with these standards has the great advantage of allowing faster placement on the market. This is because, if the manufacturer provides evidence that the product has passed all the necessary tests prescribed in the standard, the product does not have to be subjected to a re-test by a third party/certification authority before being placed on the market.

The manufacturer may also choose to follow one of the alternative standards, like the ones referred to by WHO. However, in these cases a sample of the product must be tested by a notified body, in the case of products falling within the scope of the EPI Regulation.

Both PPE and MD are divided in risk scales in accordance with the severity of the risk they are meant to deter.

PPE intended to protect against harmful biological agents, such as viruses, are listed in Annex I of Regulation (EU) 2016/425 as category III – including risks that may cause very serious consequences, such as death or irreversible damage for health. These should be subjected to specific combination of conformity assessment procedures, which are described in the same Regulation, require the mandatory involvement of a third-party conformity assessment body.

Relevant MD, namely non-invasive devices, are in Class I – low or moderate risk for user´s health. These should be subjected to the conformity assessment procedure for the EC declaration of conformity, without the involvement of a third-party conformity assessment body.

Keeping up with the effort to address the COVID-19 emergency, the European Commission requested all notified bodies to prioritise any new requests submitted by manufacturers for COVID-19 related products. Moreover, it also provides 2 possible scenarios for products to be placed on market, even if the conformity assessment procedures have not been yet finalized or even initiated:

1. even when the conformity assessment procedures, including affixing CE marking, have not yet been fully finalized (for a limited period of time and while the necessary procedures are being carried out) if the authorities consider that the equipment ensures an adequate level of health and safety that is in line with the essential requirements laid down in EU law

2. In exceptional circumstances, products can be placed on the market without the certification procedures having been started and no CE marking been affixed if the cumulative conditions are met:

  • a. products are manufactured in accordance with one of the EN standards or in accordance with any of the other standards referred to in the WHO guidelines or a technical solution ensuring an adequate level of safety;

  • b. products are part of a purchase organized by the relevant Member State authorities;

  • c. products are only made available for healthcare workers;

  • d. products are only made available for the duration of the current health crisis;

  • e. products are not entering the regular distribution channels and made available to other users.

The Portuguese Scenario

Portugal has been rallying efforts and investment to keep up with the regulatory challenges of the new COVID-19 world.

Portugal is in line with all the aforementioned regulations. In order to adapt the national procedures to the Recommendation (EU) 2020/403 of the Commission, of 13 March 2020, the nation approved the Decree-Law no. 14-E / 2020, of 13 April. This law outlines exceptional and transitional rules regarding the manufacture, import, placing and availability on the market of MD and PPE.

The National Authority of Medicine and Health Products - INFARMED - together with Food and Economic Security Authority – ASAE - and Portuguese Quality institute – IQP - published a document setting out the technical specifications that masks, intended for use within the scope of COVID-19, must comply with. In this document, a categorization in 3 levels is made based on user type. It defines the correct mask for each class of user and the necessary regulatory qualifications and technical specifications that they must comply with.

The General Health Authority – DGS - also provided Guidelines for placing non-CE marked products on the market by national manufacturers who do not normally produce them.

In addition to PPE and MD, an important tool in the arsenal of public health is the use of so-called community masks, that can be single use or reusable. These community or social-use masks are considered a textile article, which can be made of different textile materials, and is intended for members of the public that cannot comply with confinement (professionals in contact with the public, professionals who are not working from home, or for the authorized movements of the general population). However, these masks must be seen as a complementary measure to other general protection recommendations and as an added utensil in the context of social distancing, and not a substitute for these.

These masks, being textile articles:

  • must be tested for Air Permeability (Breathability) and Particle Retention Capacity (Filtration);

  • must allow for 4 hours of uninterrupted use without degradation of the particle retention capacity or of the breathability;

  • should have no degradation of performance throughout the useful life of the product (maximum number of times that can be reused) and

  • must have adequate design and construction.

Regarding the reuse of these masks, performance studies should be carried out after simulation of the actual use and the number of maximum reuse cycles foreseen.

For the use of social masks to be successful, it is essential that the user is informed of its characteristics as well as its limitations, including reuse process (washing, drying, conservation, maintenance) and the number of reuses, among others. ASAE, as a Market Surveillance Authority, is responsible for inspecting these products.

To help consumers and producers recognize the community masks that are compliant with the needed requirements, the Technological Center for the Textile and Clothing Industries - CITEV , a laboratory with technical recognition, created a seal that offers consumers and producers the ability to recognize that the product or raw materials have been tested and validated by accredited laboratories, thus giving a guarantee of quality.

Societies around the world are only now starting to rise up to the challenge of facing the COVID-19 pandemic. The constant flow of new information and knowledge generated by the combined effort of the many individual people fighting the disease is probably our best chance of overcoming this threat and regaining some normality. Nonetheless, this flow of information can seem at times overwhelming and confusing. Misinformation and disinformation in the health space were already thriving before and gained renewed frenzy with COVID-19. It is important to rely only on authoritative sources to get updated information.