In order to better manage the emergency due to the COVID-19 and ensure the supply of protective device against the virus, the Italian Authority has taken some extraordinary measures.
A special manufacturing authorization procedure has been set up to speed up and simplify the authorization for the production and supply of protective masks that are not bearing the CE mark.
The ISS has created the special working group “Gruppo di lavoro dispositivi medici COVID-19” with the task of assessing the safety compliance to the current Directive for the use in derogation of protective facial masks, including those that are not CE marked, with a medical intended purpose.
The procedure foresees the submission to ISS of a reduced documentation to demonstrate the conformity to the safety requirements expected by the relevant technical standard. This authorization will remain valid until the end of the COVID-19 emergency. Also, evidence of a ISO 13485 quality system suitable for manufacturing management must be provided.
This working group is already full operational and in direct contact with the Italian Ministry of Health in order to provide the interested companies with all the required information and clarification.
The technical and administrative procedures are described in the explanatory note at the following link: Art. 15 del Decreto Legge del 17/03/2020 n.18.
RPN is available to assist companies in the preparation and submission of the documentation to obtain the special authorization for the manufacturing and commercialization of protective masks with medical purpose. Please do not hesitate to contact us for any support.