EU Commission Clarifies Market Placement Rules for PPE under B+C2 Conformity Assessment

The European Commission has released a comprehensive guideline clarifying that personal protective equipment (PPE) in Category III following the B+C2 conformity assessment procedure must undergo the initial product check before being placed on the market. The guideline aligns with Regulation (EU) 2016/425 and specifies that the first product check is mandatory for affixing the CE marking and meeting the criteria of conformity.

The updated regulation ensures that manufacturers adhere to strict standards by conducting product checks annually. These assessments align with the requirements of Decision No 768/2008/EC within the New Legislative Framework. Manufacturers are obligated to obtain an EU type-examination certificate and ensure that the PPE complies with health and safety requirements.

The guideline emphasizes that placing PPE on the market should only occur after all conformity assessment steps, including the initial product check, have been successfully completed.