CE Marking of face masks and PPE. What importers need to know.
CE marking of face masks and personal protective equipment: what importers need to know.
News
News and articles about CE marking
UK Health and Safety Authority Issues Warning on Face Masks
The UK’s Health and Safety Authority issues a warning on the poor quality of KN95 face masks.
Machinery Directive 2006/42/EC: European Commission updates list of European Harmonized Standards
The EU publsihed an update to the list of standards for machines was published today. These standards may be applied to prove conformity with the CE directive for machinery.
Corona-crisis: European Commission publishes guides for manufacturers of essential medical devices and PPE
Today, the European Commission published three guidance documents to assist manufacturers to increase production of essential medical equipment and material in three areas: the production of masks and other personal protective equipment (PPE), leave-on hand cleaners and hand disinfectants and 3D printing in the context of the coronavirus outbreak.
More than half million Chinese face masks recalled
600,000 face masks that the Dutch government has imported from China are faulty. Because the masks were already distributed to hospitals, the Ministry of Health has launched a recall.
The European Commission confirms proposal to postpone the MDR
The European Commission confirms: it is preparing a proposal to postpone the implementation of the Medical Device Regulation (EU) 2017/745 with one year.
Medical devices and IVDs: List European harmonised standards updated
The European Commission has published an update of the list of European harmonised standards under the Medical Devices Directive (93/42/EC), the Active Implantable Medical Devices Directive (90/385/EEC) and the In Vitro Diagnostics Directive 98/79/EC.
Medical Device Regulation (MDR): new guidance documents published
Today, the European Union’s advisory organ for medical devices, the