Notified Body for the PPE-Regulation (EU) 2016/425

RISE is a Notified Body for EU type approval of Personal Protective Equipment according to the European Regulation (EU) 2016/425. The type approval procedure gives the manufacturer possibility to put the CE-mark on the product, which is a requisite to put the product on the market within the Community.

For manufacturers of personal protective equipment, of category II and III, the manufacturer have to engage a Notified Body which by an EU type examination confirms that the product fulfils applicable requirements in the directive. The type examination is executed according to a harmonized European standard if such a standard exists. 
After an EU-type approval, an EC type examination certificate is issued. Together with , among others, the manufacturers declaration of conformity, the manufacturer can put the CE-mark on the product. When it comes to products of category III, the manufacturer have to, in addition to the type approval, also engage a Notified Body performing a surveillance activity. This can be done either by control of  finished products or by assessment of the manufacturers quality system. The manufacturer chooses which alternative is best for him.

RISE notification in the field of PPE covers: 
  • Type approval according to module B of the Regulation
  • Assessment of finished products according to module C2
  • Assessment of the manutacturers quality systems according to module D of the Regulation


Product areas:

  • Equipment for protection against falls from a height 
  • Head protectors (helmets and other headgears for professional and private use, face protectors for ice hockey players) 
  • Protective clothing, gloves (Chemical attack, heat) 
  • Protective clothing (High visibility, reflecting materials) 
  • Reflectors
  • Protective Eyewear used in the game of Floorball
RISE Research Institutes of Sweden, Phone 010-516 50 00, E-mail info@ri.se

The RISE institutes SP, Innventia and Swedish ICT have merged in order to become a stronger research and innovation partner for businesses and society.
During 2017 sp.se will be one of several websites within RISE. Please visit ri.se for more information about RISE.