2. Mask CE certification is the most popular product certification recently, and it is compulsory certification for exporting to EU countries. Masks belong to category 3 products of personal protection instructions in Europe (very high safety level), and the European standard is EN 149.
3. There are two modes of certification: (1) sending samples to mask laboratories in Europe for testing every year, and submitting complete quality system technical documents, drawings, factory testing reports and other documents. If the documents are complete, the personnel of EU institutions may not conduct an on-site audit of your factory system. (2) Send samples to European laboratories for testing every year, plus factory audit twice a year. Many institutions only accept the application of the second method, because the certification bodies of the second method are more at ease.
4. There is another possibility. If your company's masks are used in hospitals, they are not within the scope of personal protection, but within the scope of medical devices, and should be explained by MDD. The process is: sample sending test, factory audit and compulsory ISO 13485 system certification.