Personal Protective Equipment Regulation EU 2016/425
Conformity, risk category, EU-type examination and CE marking obligations for PPE.
Sectors
Articles (48)
Article 1 — Subject matterArticle 2 — ScopeArticle 3 — DefinitionsArticle 4 — Making available on the marketArticle 5 — Essential health and safety requirementsArticle 6 — Provisions concerning the use of PPEArticle 7 — Free movementArticle 8 — Obligations of manufacturersArticle 9 — Authorised representativesArticle 10 — Obligations of importersArticle 11 — Obligations of distributorsArticle 12 — Cases in which obligations of manufacturers apply to importers and distributorsArticle 13 — Identification of economic operatorsArticle 14 — Presumption of conformity of PPEArticle 15 — EU declaration of conformityArticle 16 — General principles of the CE markingArticle 17 — Rules and conditions for affixing the CE markingArticle 18 — Risk categories of PPEArticle 19 — Conformity assessment proceduresArticle 20 — NotificationArticle 21 — Notifying authoritiesArticle 22 — Requirements relating to notifying authoritiesArticle 23 — Information obligation on notifying authoritiesArticle 24 — Requirements relating to notified bodiesArticle 25 — Presumption of conformity of notified bodiesArticle 26 — Subsidiaries of and subcontracting by notified bodiesArticle 27 — Application for notificationArticle 28 — Notification procedureArticle 29 — Identification numbers and lists of notified bodiesArticle 30 — Changes to notificationsArticle 31 — Challenge of the competence of notified bodiesArticle 32 — Operational obligations of notified bodiesArticle 33 — Appeal against decisions of notified bodiesArticle 34 — Information obligation on notified bodiesArticle 35 — Exchange of experienceArticle 36 — Coordination of notified bodiesArticle 37 — Union market surveillance and control of PPE entering the Union marketArticle 38 — Procedure at national level for dealing with PPE presenting a riskArticle 39 — Union safeguard procedureArticle 40 — Compliant PPE which presents a riskArticle 41 — Formal non-complianceArticle 42 — Delegated powerArticle 43 — Exercise of the delegationArticle 44 — Committee procedureArticle 45 — PenaltiesArticle 46 — RepealArticle 47 — Transitional provisionsArticle 48 — Entry into force and application