Latest Release! Guide For Export Of Masks And Other Anti Epidemic Products To The European Union (Second Edition)

I. CE marking system

The CE marking system is the EU's regulation of products entering the EU market. Products labeled with CE indicate that the products comply with EU's requirements for safety, health and environmental protection. They can be legally marketed in 4 countries of the 27 EU Member States, the European Free Trade Zone, and the United Kingdom and Turkey. According to the EU regulations, different products are evaluated by different ways of evaluation and affixed with CE markings. There are mainly two ways: most of the products are manufacturers who adopt the self declaration of conformity, and they can add CE marks. Some of the products with relatively higher risk are subject to the third party authorized by the European Union, namely the announcement institution (Notified). Body) after the conformity assessment, the CE logo can be added.  

The EU has formulated different regulations (directives) for different products, such as children's toys, low voltage electrical appliances, personal protective devices, medical devices, etc., with corresponding regulations (instructions). The EU regulations (Directive) specify the basic requirements for the quality and safety of the corresponding products, as well as the listing process and conformity assessment procedures.  

The product is self declaration by the manufacturer and the process of adding CE logo: the manufacturer must ensure that his products comply with the EU regulations, the products are safe and effective, and establish relevant technical documents, sign the declaration of conformity, and register the products with the CE mark after entering the registration authorities of the member States, and enter the European Union for sale.  

The process of adding the CE logo to the products after the announcement of the conformity evaluation of the products: the product manufacturer applies to the announcement organ, the announcement institution provides the conformity assessment service for the manufacturer, and the manufacturer and the product comply with the requirements of the regulations, and issue the CE certificate to the manufacturer. The manufacturer signs the compliance statement according to the CE certificate, and can enter the European Union market after the product is affixed with the CE logo. The following table lists the responsibilities of the authorities, announcements and manufacturers of the European Union and Member States.  

Two. Classification and standard of masks in China and Europe

Masks are divided into two types of medical masks and personal protective masks according to their intended uses. They are respectively assigned to the medical devices Ordinance EU2017/745 (MDR) or the medical device directive 93/42/EEC (MDD) and the personal protective equipment Ordinance EU2016/425 (PPE). How to determine which kind of mask the specific product belongs to should be referred to the corresponding regulations and standards.  

In China, masks are usually divided into masks and medical masks. For the sake of understanding, the Chinese mask types and standards and the European Union mask types and their application standards are specifically matched, so as to help you understand what your masks may be corresponding to the European Union masks and the requirements to meet that standard. What needs to be explained is that this correspondence is not a strict correspondence, and there are differences between Chinese and European standards.

  Three, masks export EU regulations   

(1) medical mask

According to the requirements of MDD or MDR, the medical non sterile mask can be self declared by the manufacturer, and will be sold on the market after adding the CE logo. The medical sterilization mask must be evaluated by the compliance of the announcement institutions before the CE logo can be added to the market for sale. But regardless of whether or not a notice institution is required for conformity assessment, manufacturers need to conduct tests in accordance with regulatory requirements, refer to relevant standards or meet EU quality requirements, so as to ensure that products are safe and effective, and establish technical documents and quality management systems to ensure the quality, safety and sustainability of products.  

1. technical documentation requirements:

Referring to the requirements of appendix II and appendix III of the MDR regulations (MDD is Appendix 7), the technical documents usually include the following seven parts:

> description and specification of equipment, including name, intended use, classification, raw materials, composition, technical specifications, etc.  

Product labels and / or instructions

Information about product design and manufacture

> meet basic safety and general performance requirements (Appendix I GSPR)

Benefit and risk analysis, and risk management documents.

Validation and validation of products, including pre clinical and clinical (assessment) data.

Post marketing supervision plan

2. manufacturer's quality management department requires:

The quality management system can be carried out according to the coordination standard ISO 13485:2016. What needs to be explained is that the quality management system needs to be run or audited with reference to ISO13485:2016, but ISO13485 certification is not mandatory or mandatory for the compliance assessment of the announcement institutions. However, most manufacturers will choose to obtain ISO 13485 certificate, which will enhance the confidence of the manufacturer in meeting the requirements of laws and regulations and product quality assurance.  

3. manufacturers authorize EU representatives

For manufacturers outside the European Union (such as Chinese manufacturers), they need to authorize an EU representative in the EU to replace the manufacturer's activities in the European Union, such as self declaration of product registration and adverse event reports in the competent authorities. Manufacturers need to sign agreements with the EU representatives and stipulate their respective responsibilities. According to the new MDR regulations, manufacturers need to submit the complete technical documents to the EU representatives for future inspection by the competent authorities.   

(two) personal protective masks

According to the PPE regulations, personal protective masks are required to be issued by the public notice organs for the issuance of CE certificates, so that they can be sold legally in the EU. According to the relevant regulations of PPE regulations on conformity, manufacturers need to establish corresponding technical documents and meet the specifications and testing requirements of EN149:2001+A1:2009. Compared with medical masks, personal protective masks need at least two certificates issued by the public notice institutions, that is, the type inspection certificate according to appendix five. According to the certificate of appendix seven (Module C2) or the certificate of appendix eight (Module D), see the following:

In order to help you get a clearer picture of the similarities and differences between medical masks and personal protective masks exported to the European Union, the following tables are summarized for your reference.

Four. List of certification bodies with the European Union's bulletin board masks and other business qualifications (updated to April 13, 2020)  

Five. Directory of medical device management system (ISO13485) certification bodies in China (updated to April 13, 2020)