Pandemic and the CE marking requirements: when solidarity changes the rules of the game

22 April 2020

In order to attend to those affected by the pandemic and to aid recovery, currently applies only and exclusively to masks and surgical gowns, temporarily relaxing the requirements for CE marking.

22 April 2020

There are many examples amongst human history that show us that the great crises we face are often times of unbridled creativity and lessons of solidarity. Thus we may refer to the zipper and the sanitary pads, devised during the First World War, or the nylon and self-service food stores, introduced during the Great Depression. Even though we sometimes need turbulent times to remind us of this, Einstein already said so: Creativity is born from anguish, just like the day is born form the dark night. It’s in crisis that inventiveness is born, as well as discoveries made and big strategies.

In these difficult times of pandemic we are seeing car factories reinventing themselves to produce respirators, large textile firms abandoning the production of collections to manufacture and distribute masks that may effectively protect us, and entire families throwing themselves into collaborative initiatives addressed to bring medical material from the other end of the world. These large and small gestures that help save thousands of lives were, until relatively recently, confronted with an unexpected barrier for many: thee necessary CE marking of medical products and personal protective equipment or PPE.

We surprisingly find that a legal obligation conceived almost 30 years ago to safeguard the health of European users and consumers became, just over a month ago, an obstacle to solidarity which, in the end, was practically insurmountable for many.

At this point it should be recalled that the CE marking system (known by the acronym Conformité Européenne or European conformity) is the guarantee by which the manufacturer/importer informs users and competent authorities that products placed on the market comply with mandatory legislation on essential requirements.

But this sign should not and cannot simply be included, a number of guidelines must be followed. In this sense, it is important not to lose sight of the fact that this is not a mark that refers to quality, but to the safety, health and environmental protection required by the EU, and failure to comply with the applicable regulations means that the products cannot be marketed in our territory. Failure to comply with this obligation entails, not only the withdrawal from the market or prohibition of the entry into circulation of the equipment, but also the imposition of fines.

The urgency of the crisis thus put society in a quandary. The fact is that masks, respirators, gloves, protective screens and other medical equipment are among those products subject to technical specifications and certification of CE marking, an obligation that incumbes both EU manufacturers and those who import products from third countries.

On one hand, the terrible situation of generalised lack of supply and, on the other hand, the exemplary solidarity of Spanish companies and citizens, led the Government to issue Order SND/326/2020 on 6 April, by virtue of which, among other measures, express authorisation is given for the placing on the market and putting into service of products for which the assessment procedures relating to the affixing of the CE mark have not been fulfilled.

This order, which seeks to attend to those affected by the pandemic and to aid recovery, currently applies only and exclusively to masks and surgical gowns, temporarily relaxing the requirements for CE marking and establishing that any posible monetary liability that may arise as a result of the use of products without CE marking or of health guarantees not required of a product, will be assumed by the General State Administration, provided that a series of basic control formalities are met. For example, the product must be delivered to the Ministry of Health with the aim of caring for those affected by the pandemic caused by COVID-19 or helping to control it, and must not involve any kind of business benefit for the natural or legal person authorised to manufacture it or any other person involved in the process.

Having said this, we must emphasize that even in these circumsntances (or even more under this specific circumsntances), before deciding to introduce your products into the trade, it is essential to take the relevant legal advice in order to verify that all the technical specifications and obligations affecting the manufacture and marketing of the good in question are met.

And in difficult times we end up as we started: with Einstein, because after all, there are not many better ways to do it:

He who overcomes crisis, overcomes himself, without getting overcome.

5/5 - (5 votes)

Marta Gimeno

Abogada.Departamento Patentes.

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