COVID-19: Medical devices and personal protective equipment (Recommendation)

SÉRVULO PUBLICATIONS 24 Mar 2020

Last week the European Commission published Recommendation (EU) 2020/403 on the conformity assessment and market surveillance procedures for Personal Protective Equipment (“PPE”) and medical devices within the scope of COVID-19.

In view of the sharp increase in demand, the Commission wants economic operators in the supply chain and market surveillance bodies and authorities to employ all possible resources to ensure the supply of these products in the European Union.

The Recommendation proposes that priority is given to conformity assessment procedures for these products. Technical solutions which are not harmonised, such as the WHO recommendations, are allowed to be adopted “provided that said technical solutions ensure an adequate level of protection corresponding to the applicable essential health and safety requirements laid down in Regulation (EU) 2016/425”.

In this event, according to this framework, certifying bodies should promptly inform the corresponding Authority of the certificates issued and the technical solution adopted, as well as all other notified bodies.

In what concerns market surveillance procedures, national authorities should provide special vigilance for PPE or medical devices which do not comply with the law and which raise “serious risks as to the health and safety of their intended users”. More importantly, it is even possible that, before conformity assessment procedures are completed, products may be allowed to be made available on the market (for a limited period) if they prove to have an adequate level of health and safety. However, because the CE marking (which assumes completion of the conformity assessment procedures) is absolutely central, the recommendation only allows Member States to purchase these products “provided that it 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”.

These provisions are extremely important at a time when it is important to strengthen production and distribution capacities for surgical masks, disposable or reusable masks that ensure protection against particles, overalls, medical examination gowns, among others, and disposable or reusable eye protection equipment used for prevention and protection against harmful biological agents such as viruses (and COVID-19).

Miguel Gorjão-Henriques | mgh@servulo.com

Michael-Sean Boniface | msb@servulo.com