In China, there are two major type of Face Mask- 3 ply Face Mask and KN95 Face Mask.The EU Medical Device Directive /Medical Device Regulation and Personal Protective Equipment Regulation control and regulate the import and sales of Face Mask in Europe.
The below table show the different regulations between China Regulation and EU Directive & Regulation. The China Face Mask Manufacturer should comply with both regulation before import the Face Mask to EU Market.
| Mask Category | Medical Mask (Non Sterile) | Medical Mask ( Sterile) | Personal Protective Equipment |
|---|---|---|---|
| Directive / Regulation | Medical Device Directive / Medical Device Regulation | Medical Device Directive / Medical Device Regulation | Personal Protective Regulation |
| Category | Medical Device Class I (non Sterile) | Medical Device Class I (Sterile) | PPE (Category III) |
| Harmonised Standard | EN 14683 | EN 14683 ＆ Sterilization Standard | EN 149 |
| Technical File | Required | Required | Required |
| Quality System | Required | Required | Required |
| Conformity Assessment | Self Declaration | Assessment by Notified Body | Assessment by Notified Body |
| CE Certificate | Not Necessary | 1 Copy | 2 Different Copies |
| Declaration o conformity | Required | Required | Required |
| CE Mark | Required | Required (CE plus 4 digit of Notified body number) | Required (CE plus 4 digit of Notified body number) |
There are three popular Face Masks in China. There are 3 individual ways to import to EU market. The Table may give you the hints and steps how to get CE Mark.
| Category of Face Mask in China | Category of Face Mask in Europe |
|---|---|
| Face Mask (GB/T32610-2016) Respiratory protection Mask (GB 2626-2006) KN90(90%), KN95(95%), KN 100(99.7%) | Personal Protective Equipment Personal Protective Face Mask EN149:2001 +A1:2009 3 Type : FFP1, FFP2 and FFP3 |
| Disposable Surgical Face Mask （YY0469-2011） Medical ace Mask (YY/T0969-2013) | Medical Device Medical Face Mask EN14683:2019 Medical Masks Type I (95%), Type II (98%), Type IIR (98%) |
Personal Protective Equipment
According to the EU PPE regulation requirements, Manufacturer / Importer must have the (Module B) and (Module C2) CE certificate / (Module D) CE certificate issued by the notified body to be sold in the EU.
The (Module C2) CE certificate is valid for half a year. The notified body needs to conduct a Module D review within half a year. Afterwards, the (Module C2) CE certificate will be replaced by the (Module D) CE certificate.
Manufacturer must obtain at least two Module B certificate together with (Module C2) or the (Module D) certificate from the notified body.
If you need further information about CE Mark Certification procedures, please leave contact information info@gabriel.uk / call +44 02034 888 333 for enquiry.
