02.04.2020

Industries: Health, Life Sciences & Pharmaceutics

Covid-19: Ramping up production of essential personal protective equipment and medical devices – procedural flexibility

Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat, deems of paramount importance to ensure that the most appropriate personal protective equipment (PPE) and medical devices ensuring adequate protection are swiftly made available to those who need it most. This should occur whenever market surveillance authorities find that PPE or medical devices ensure an adequate level of health and safety, even if conformity assessment procedures, including the affixing of CE marking, have not been fully finalized.

The same Recommendation admits the possibility of PPE or medical devices not bearing the CE marking being assessed and part of a purchase organized 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.

 

Upon the urgent request of the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), made freely available a number of European standards for certain medical devices and personal protective equipment.

The Commission made available guidance to assist manufacturers in ramping up production of essential medical equipment and material in three areas: the production of masks and other personal protective equipment (PPE), leave-on hand cleaners and hand disinfectants and 3D printing in the context of the coronavirus outbreak. These documents also aim to assist manufacturers and market surveillance authorities in making sure these products comply with necessary safety standards and are effective. A guidance on medical devices will also be made available within the coming days.

In view of the temporary suspension of the mandatory bearing of the CE marking, in Portugal, public entities responsible for assessing conformity with essential established health and safety requirements are INFARMED, for medical devices, and ASAE - Economic and Food Safety Authority, for individual protection equipment.

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