Regulation (EU) 2016/425 of 9 March 2016 on personal protective equipment (the PPE regulation) covers the design, manufacture and marketing of personal protective equipment. It defines legal obligations to ensure that PPE on the EU internal market provides the highest level of protection against risks. The CE marking affixed to PPE provides evidence of compliance of the product with the applicable EU legislation.

As legislation based on the 'new approach' aligned to the new legislative framework policy, manufacturers or their authorised representative in the EU must comply with the essential health and safety requirements of the PPE regulation, directly or by using harmonised European standards. The latter confer presumption of conformity to legal requirements. Further explanations on the different elements of the new legislative framework can be found on the ‘Blue Guide on the implementation of the product rules’.