A few days ago we explained why in Spain, from Wednesday 30th September, it would not be possible to sell KN95 masks (the Chinese counterparts to our FFP2) or those personal protective equipment (PPE) without CE marking, which shows that the product follows European regulations. However, a new Resolution of 28 September states that all PPE purchased before 1 October 2020 may be received and marketed until 31 December 2020, provided it can be shown that they had the corresponding temporary authorisation and that they were already in Spanish territory before the beginning of October.
According to the Resolution of 23 April 2020 of the General Secretariat of Industry and Small and Medium-sized Enterprises, referring to personal protective equipment in the context of the health crisis caused by COVID-19, in view of the shortage of PPE with the regulatory CE marking during the first months of the pandemic, it was necessary to accept other PPE that did not have this marking.
The resolution indicated that this authorisation would be temporary and that it would end either when the assessment required to affix the CE marking to these products was completed or on 30 September 2020.
From then on, the masks in the market have to have the correct notified body certification or they will be incurring in an illegality and that is why we can now find offers related to this type of masks (KN95), because they are trying to remove stock of non approved ones.
EPI WITHOUT CE MARKING CAN BE MARKETED UNTIL 31 DECEMBER 2020
According to the Resolution of 28 September 2020 of the General Secretariat for Industry and Small and Medium-sized Enterprises concerning personal protective equipment in the context of the health crisis caused by COVID-19, all PPE purchased before 1 October 2020 may be received and placed on the market until 31 December 2020.
However, this will only occur in the case of "product units in stock which can demonstrate that they were already in Spanish territory prior to 1 October 2020, and which had obtained the corresponding temporary authorisation prior to that date".