“The placement of medical devices on the national market was identified: type I surgical mask, brand MM4M, ref. MMPA1320000099.B; type II surgical mask, brand MM4M, ref. MMPA1320000099.B; surgical mask type IIR, brand MM4M, refs. MMPA132R000099.0 and MMPA132R000099.B, from the national manufacturer PT Mills Lda., bearing improper CE marking, as there is no evidence of compliance with the legal requirements applicable at European level, namely with regard to technical documentation in relation to the established", says the National Authority for Medicines and Health Products (Infarmed) in an information circular.
Infarmed determined the immediate suspension of the sale and collection of these surgical masks from the national market.