Regulation (EU) 2016/425 for manufacturers and suppliers of PPE
On April 21, 2018, Directive 89/686/EEC was repealed and replaced with Regulation (EU) 2016/425. The change imposes new conditions upon manufacturers and suppliers of PPE in Europe, including the following additional requirements:
- New responsibilities for importers and distributors
- Some products which were Category II are now moved to Category III
- An assessment of the risks against which the PPE is intended to protect
- Changes in requirements for product marking, including manufacturer name, registered trade name or registered trade mark, and postal address
- Instructions for use, labelling and EU Declaration of Conformity must be supplied with PPE and in the language easily understood by consumers and end users. Below you will find the links to the Declaration of Conformity for each of the Cardinal Health Surgical glove products sold in Europe.
Standard English DOC for Curity Powder-Free surgical gloves can be found here.