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4/6/2020

Legal News: Standards and standardisation in the context of COVID-19

Standards and standardisation in the context of COVID-19

Towards a more flexible conformity assessment procedure for protective equipment and medical devices in times of crisis

In the current context of the COVID-19 epidemic, the demand and need for protective and medical devices (masks, gloves, etc.) is increasing and there are major supply difficulties.

These various products, which make up either personal protective equipment (PPE) such as masks, gloves, protective suits or goggles, or medical devices such as surgical masks, examination gloves and certain gowns, fall within the scope of a European regulation which lays down important health and safety requirements relating to the design, manufacture and placing on the market of these products (Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and Council Directive 93/41/CCE of 14 June 1993 concerning medical devices repealed by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 with effect from 26 May 2020).

Within the framework of this regulation, manufacturers must apply the provided and applicable conformity assessment procedures (including the intervention of a third-party conformity assessment body) in order to place medical devices and/or PPE on the market and affix the CE marking where conformity with the essential health and safety requirements has been demonstrated in a conformity assessment procedure.

In view of the crucial needs of healthcare workers and the general public, the European authorities wanted to facilitate a quicker provision of these products.

On 13 March, the European Commission therefore published a new Recommendation 2020/403 on conformity assessment and market surveillance procedures in the context of the threat posed by COVID-19, which renders this mechanism more flexible.

The Commission states in particular:

“Where market surveillance authorities find that PPE or medical devices ensure an adequate level of health and safety in accordance with the essential requirements laid down in Regulation (EU) 2016/425 or the requirements of Directive 93/42/EEC or Regulation (EU) 2017/745, even though the conformity assessment procedures, including the affixing of CE marking have not been fully finalised according to the harmonised rules, they may authorise the making available of these products on the Union market for a limited period of time and while the necessary procedures are being carried out.”

[…]

PPE or medical devices not bearing the CE marking could also be assessed and part of a purchase organised by the relevant Member State authorities provided that is ensured that such products are only available for the healthcare workers for the duration of the current health crisis and that they are not entering the regular distribution channels and made available to other users.”

The free making available of European standards for protective and medical devices was also organized at the same time by the European Commission and CEN-CENELEC (European Committee for Standardization in Electronics and Electrotechnology) to help combat the spread of COVID-19.

Muriel MAZAUD                                                                                6th April 2020

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