Notified Body 1024

The Notified Body RILSA-OS 1024 provides manufacturers of personal protective equipment (PPE) with services consisting of conformity assessment of products with the essential health and safety requirements set out in Regulation (EU) 2016/425. On this basis, the manufacturer issues the EU Declaration of Conformity and affixes the CE marking to the product. The Declaration of Conformity is the outcome of the conformity assessment procedure, the variants of which correspond to the level of risks against which the PPE is intended to protect the user (see Regulation (EU) 2016/425, Annex I).

The technical requirements for PPE, referred to as the “Essential Health and Safety Requirements,” are defined in Annex II of Regulation (EU) 2016/425. These requirements are formulated in broad terms and deliberately avoid prescribing specific numerical values or limits. Concrete values, thresholds, testing procedures, and other technical specifications corresponding to the essential requirements are further elaborated in harmonized Czech technical standards. While the use of these standards is not mandatory, compliance with them provides a presumption of conformity with the essential requirements of Regulation (EU) 2016/425.

Because PPE is designed to protect against risks of substantially varying severity, products are classified into three categories, and the conformity assessment procedures differ accordingly (see Categorization and General Procedures of Conformity Assessment). Nevertheless, the manufacturer always bears the ultimate responsibility for the product. Detailed information regarding the harmonized approach to PPE conformity assessment within the European Union is available on the website of the European Commission.