In order to facilitate the supplies of face masks and of personal protective equipment and medical aids in general which are needed to deal with the health emergency, the emergency legislation has introduced new validation procedures for those devices.
In particular, as concerns face masks the Cura Italia decree has made a distinction between devices to be used by workers and those generally intended for the population. In both cases new rules aimed at making it easier to place products without an EC mark on the market have been implemented, but with significant differences between the two:
- Face masks for workers in the work place: a) the devices must meet certain standards which under normal circumstances would have allowed the product to obtain the EC mark; b) before placing such devices on the market the validation procedure outlined by art. 15 of Law Decree no. 18 dated 17 March 2020 must be carried out.
The validation procedure is different for surgical masks and for the other PPE. Surgical masks producers, importers and those who place them on the market must send a self-declaration to the Istituto Superiore di Sanità stating that the masks comply with all the safety rules in force. Within 3 days from the date on which the self-declaration is sent the producers and the importers must send any material necessary to validate the surgical masks to the ISS. Within 3 days from the receipt of such documentation the ISS determines whether the masks comply with the rules in force. It is though important to note that the 3 day term within which the validation should occur is not mandatory and that the tacit approval rule does not apply. Therefore, those products will not be allowed to be placed on the market until the ISS expressly approves them. The validation procedure for the PPE other than surgical masks is the same but it is INAIL who must see to the validation.
Manufacturers, importers and those who place on the market PPE which does not comply with the rules in force shall be punishable in accordance with art. 14 of legislative decree dated 19 February 2019 which provides administrative and criminal penalties according to the specific category of the non-complying PPE.
- 16, paragraph 2, of Law Decree no. 18 dated 17 March 2020 deals with how face masks which cannot be considered PPE (which, therefore, cannot be used by workers and medical staff) should be placed on the market. It states that people in Italy can use face masks that do not have the EC mark and that have been manufactured in departure from the marketing rules in force. As a confirmation of this, INAIL has clarified that “for the other kinds of face masks that are not for medical use nor PPE and that, therefore, are not intended for medical staff nor for the protection of workers for whom specific safety devices are provided, no validation procedure in accordance with art. 15 is required. They can be produced in departure from the current marketing provisions pursuant to art. 16 of Law Decree no. 18/2020 under the producer’s responsibility who must in any case guarantee the safety of the product”.
