Personal Protective Equipment

Introduction to Personal Protective Equipment in the EU Market

Specialized clothing such as goggles, gloves, helmets or masks that are intended to protect the wearer from inherent hazards have a broad spectrum of applications from heavy machinery environments to sports. These hazards may include biohazards, heat, physical, electrical, heat, chemicals or airborne.

Personal Protective Equipment Legislation

Until the publication of the Personal Protective Equipment Regulation 2016/425/EU on March 9, 2016 the subsequent two year transition period, the Personal Protective Directive 89/686/EEC was the reigning legal framework for medical devices.

While the Personal Protective Regulation 2016/425 repealed the PPE Directive 89/686/EEC with effect from 21 April 2018, equipment that has a valid EC-type examination Certificate issued according to the old Directive may still be placed on the market until the expiration date of corresponding EC-type examination certificate (no later than 21 April 2023).

From April 21st, 2018, the  PPE Regulation 2016/ 425/EU became fully applicable in the EU as the main legal framework for personal protective equipment.


KEY FACTS:

  • Any product placed and made available on the EU market (either through e-commerce or traditional retail) must comply with the Personal Protective Equipment Regulation 2016/425
  • Non-EU based manufacturers should appoint European Authorized Representative (EAR)
  • Manufacturer is defined as:
any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark
  • Higher risk PPE (Category II & III) will require the intervention of a Notified Body to obtain the CE Mark
  • Products which fail to comply may be subject to public notification (RAPEX), withdrawal requirements, warehousing fees, fines or total destruction of the products.

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