In the wake of the high demand for PPE and medical devices in the EU, Chinese suppliers have restarted exporting to Europe. However, the European Safety Federation has identified some suspicious CE certificates for both  PPE and medical devices. The suppliers have either used fake documents or showed certificates by the wrong authorities. Since a CE mark is compulsory for all  PPE and medical devices exported to Europe, this newsletter delves into product classification for PPE and medical devices and product classification by EU regulation. There are 2 regulations, namely, Regulation (EU) 2016/425, which is on PPE and Regulation (EU) 2017/745, which is on medical devices and accessories. It has been mandated that all medical products and PPE to be sold in the EU need to come under any of these regulations. All suppliers should have knowledge about the procedure for Certified CE Mark, the risk categories, classification of medical devices and types of notified bodies as well as their names in the regulations. 

Share This:
Download Pdf