PPE Regulation (EU) 2016/425

Short answer

Personal protective equipment is regulated by Regulation (EU) 2016/425 and classified in three risk categories. Category I (minimal risks) uses internal production control. Category II requires an EU type-examination by a notified body. Category III, for risks of death or irreversible damage, also requires ongoing production surveillance by a notified body.

Risk categories

CategoryExamplesConformity assessment
IGardening gloves, sunglassesModule A, internal production control
IISafety helmets, high-visibility clothing, eye protectionModule B (EU type-examination) + module C
IIIRespiratory protection, fall protection, chemical protectionModule B + module C2 or D

Notified bodies

For category II and III, the notified body's identification number accompanies the CE marking. Always verify the body and its scope in the European Commission's NANDO database before accepting a certificate.

Authority in Romania

Personal protective equipment used at work is checked by the Labour Inspectorate (Inspecția Muncii).

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