Personal Protective Equipment (PPE) provides protection against one or several risks to a person’s health or safety.
BioReg experts can help PPE manufacturers comply with specific PPE requirements in the EU for all risk categories.
Beginning from 2018, PPE must comply with requirements detailed in Regulation (EU) 2016/425. This Regulation defines the Risk Categories of PPE (Annex I). In addition, the manufacturers must issue a Declaration of Conformity (DoC) with each PPE. The obligations for importers and distributors of PPE are provided in Articles 10 and 11, respectively.
To claim conformity with the Regulation (EU) 2016/425., the manufacturer must meet all the applicable Essential Health and Safety Requirements in Annex II and draft up a Declaration of Conformity. Manufacturers must establish a compliant technical file for their PPE, as outlined in Annex III. The technical file includes the list of applicable Essential Health and Safety Requirements, design and manufacturing drawings of the PPE, applicable test reports, and a copy of the manufacturer’s instructions.
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