All head protection must be tested and certified as Personal Protective Equipment (PPE) Regulation – PPE Directive (EU) 2016/425 before being legal to be sold in the UK and Europe. PPE legislation is a completely separate piece of legislation from, and should not be confused with the Medical Devices Directive. Head protection cannot be legally tested or classified as a medical device, as it does not provide a therapeutic benefit.
Head protection falls into either Category II (independent testing and certification) or Category III (independent testing and certification, plus ongoing surveillance of production quality). It is illegal to place any protective headwear on the UK and European product market for sale without certification. Any person or organisation that claims that protective headwear is Category I PPE or a medical device is incorrect.
For Category II and III products, independent European notified bodies provide EEC Certification to show that the manufacturer’s products have complied to the PPE Legislation, and that manufacturers may put their CE mark on a product. The independent European notified body will ensure testing covers all of the essential requirements of the PPE legislation. A manufacturer of a protective headwear can only place a CE mark on to the product and/or packaging if the product has been tested and certified by an independent European notified body.
Halos® is the first and only legally approved sports protective wearable of its type in the UK and Europe, having secured Category II PPE certification from Italcert Notified body No.0426, and is legally approved to use the CE mark.