According to the Spanish Ministry of Health, in order to supply health centers with the necessary medical devices for managing the health crisis caused by COVID-19, exceptional measures must be taken to facilitate the manufacture and marketing of certain medical devices at an appropriate pace to deal with the considerable volume of patients infected by COVID-19.
Thus, Order SND/326/2020, of 6 April, applicable, for the time being, to face masks and white coats classified as medical devices, aims at (a) facilitating the manufacture of these medical devices, and (b) allowing them to be placed on the market despite not having satisfied the relevant conformity assessment procedures, i.e. without bearing the CE mark:
- Although, as per Section 9 of the Spanish Medical Device Regulation currently in force (RD 1591/2009), the manufacture of these medical devices will continue to require prior authorization for the operation of facilities. However, the Spanish Agency of Medicinal Products and Medical Devices (AEMPS), with the aim of speeding up the procedure, may, at the request of the interested party, grant an exceptional authorization or a temporary amendment of the existing one.
- Under the umbrella of Section 15 of RD 1591/2009, which empowers the AEMPS to expressly and individually authorize, in the interest of health protection, the marketing of devices for which the relevant conformity assessment procedures have not been fulfilled, the AEMPS is urged to issue whatever express authorizations are necessary for the use of face masks and white coats in spite of not having fulfilled those conformity assessment procedures and, therefore, not bearing the CE mark.
Order SND/326/2020, which comes into force 7 April, will be applicable until the end of the state of alert and its possible extensions.
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Authored by Santiago Garrido and Álvaro Abad