Recommendation 2020/403 - Conformity assessment and market surveillance procedures within the context of the COVID-19 threat - Main contents

EN

Official Journal of the European Union

LI 79/1

In the context of the current COVID-19 global outbreak as well as the rapid spread of the virus across various regions of the EU, the demand for personal protective equipment (hereinafter ‘PPE’) such as face masks, gloves, protective coveralls or eyewear protection, as well as for medical devices such as surgical masks, exploration gloves and some gowns, has seen an exponential growth. In particular, the supply chain of certain types of PPE such as the disposable face masks is under severe strain, due to the exponential growth of the demand both via existing as well as via new channels. In addition, the global supply chain of such products has also sustained significant disruptions, which have induced repercussions on the EU market as well.

Bearing in mind that the health and safety of the EU citizens is of upmost priority, it is of paramount importance to ensure that the most appropriate PPE and medical devices ensuring adequate protection are swiftly made available to those who need it most.

Economic operators active across the EU are working relentlessly to increase their respective manufacturing and distribution capacity. In order to mitigate the effects of the various disruptive factors, the economic operators are redesigning their supply chains by launching new manufacturing lines and/or diversifying their supplier base. These efforts by the industrial stakeholders would not be able to produce their full effects if the increased supply cannot feed into the market without any undue delays.

The requirements for the design, manufacturing and placing on the market of personal protective equipment are laid down by Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (1).

The requirements for the design, manufacturing and placing on the market of medical devices are laid down by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (2). That Directive is repealed by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (3), with effect from 26 May 2020.

Disposable and re-usable face masks ensuring protection against particulate hazards, disposable and re-usable coveralls, gloves and eyewear protection, which are used for prevention and protection against harmful biological agents such as viruses are products falling within the scope of the Regulation (EU) 2016/425.

Surgical masks, examination gloves and some types of gowns are products falling within the scope of Directive 93/42/EEC and of Regulation (EU) 2017/745.

In the context of the COVID-19 threat, such PPE and medical devices are essential for healthcare workers, first responders and other personnel involved in the efforts to contain the virus and avoid its further spread.

Regulation (EU) 2016/425 fully harmonises the rules for the design, manufacturing and placing on the Union market of PPE and sets out a number of essential health and safety requirements for PPE based on a classification of PPE depending on the risk against which it is intended to protect users. Thus, items of PPE manufactured...