As of 21 April 2018, Directive 89/686/EEC is repealed by the new Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment.
The new PPE Regulation is aligned to the New Legislative Framework policy. In addition, it slightly modifies the scope and the risk categorisation of products. It also clarifies the documentary obligations of economic operators.
The regulation continues to apply every device or means intended to be worn or held by a person, to protect them from one or more risks to their health or safety. Also covered are interchangeable components and connexion systems of personal protective equipment that are essential for its proper functioning.
PPE can be categorised according to the risk against which PPE is intended to protect users (Regulation (EU) 2016/425, annex I). The Regulation provides for three categories of PPE;
• Category I - includes exclusively for minimal risks
• Category II - risks other than those listed in Categories I and III
• Category III - includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health
The extent of control on the manufacturer's production and quality system, and the degree of involvement of a notified body, is determined by the category (Regulation (EU) 2016/425, article 19).
For high risk PPE (Category III), an EU type examination (Regulation (EU) 2016/425, annex V) and production monitoring (Regulation (EU) 2016/425, annex VII or annex VIII) must be performed by a notified body. In this case, the contents of the certification procedure for obtaining the CE label or the GS mark are comparable; therefore, the GS mark is not used for this field.
However, the less demanding PPE (Categories I and II), which is either labelled with the CE marking by the manufacturer without a certificate from a notified body (Category I), or is only subjected to a EU type examination (Category II), can obtain a GS mark after a corresponding test.