Masks exported to Europe and the United States requirements

Masks exported to Europe and the United States requirements, the following is also from the daily transportation and the relevant part of the transport requirements, but also please refer to:

First, the European Union on the masks and other epidemic prevention supplies access requirements

(a) masks

European Union according to the use of masks are divided into two categories: medical masks and personal protection masks.

1. Medical masks

Medical masks need to be labeled with CE marking in accordance with the European Union Medical Devices Directive 93/42/EEC (MDD) or the European Union Medical Devices Regulation EU2017/745 (MDR), which corresponds to the standard EN14683. According to the sterility of masks or the non-sterile state, the mode of conformity assessment adopted is also different.

(1) Sterile medical masks: CE marking must be done by an authorized notified body.

(2) Non-sterile medical masks: Enterprises only need to make CE self-compliance declaration, and do not need to be certified by the notified body. After preparing the appropriate documents and test reports and other information, you can complete your own declaration of conformity.

2. Personal protective masks

Personal protective masks do not belong to medical devices, but need to comply with the European Union Personal Protective Equipment Regulation EU2016/425 (PPE) requirements, CE certification by the authorized bulletin board and issue certificates, corresponding to the standard is EN149.

(2) protective clothing

protective clothing is divided into medical protective clothing and personal protective clothing, management requirements and the same as the announcement agency certification. and personal protective clothing, management requirements and masks are basically similar. Medical protective clothing in accordance with the management of medical devices, including sterile medical protective clothing in accordance with the European Union Medical Devices Directive 93/42/EEC (MDD) or the European Union Medical Devices Regulation EU2017/745 (MDR) to obtain CE certification, non-sterile medical protective clothing only need to carry out CE self-declaration. Personal protective clothing is required to obtain CE marking in accordance with the EU Personal Protective Equipment Regulation EU2016/425 (PPE).