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Understanding PPE Regulation (EU) 2016/425

04 April 2021

Overview of PPE Regulation (EU) 2016/425

From 21st April 2018, PPE Regulation (EU) 2016/425 shall replace Directive 89/686/EEC.

The PPE regulation covers the design, manufacture and marketing of personal protective equipment (PPE). It defines legal obligations to ensure that PPE on the EU internal market provides the highest level of protection against risks. The CE marking affixed to PPE provides evidence of compliance of the product with the applicable EU legislation.

 

Timescale

  • Products in the supply chain before 21st April 2019 that comply with the former PPE Directive can continue to be made available after this date.
  • Certificates issued under the former PPE Directive remain valid until 21st April 2023 unless they expire before that date.
  • From 21st April 2019, all newly made products will need to conform to the new PPE Regulation.

 

How is PPE defined?

Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety.

 

What is PPE compliance?

PPE products are classified into one of three categories, depending upon the level of risk associated with their use.

  • Category I
  • Category II
  • Category III

 

Test Certificates

PPE covered by categories II and III require the product to be certified by a Notified Body (NB).

EU type-examination certificates will be issued for a maximum term of five years, after which the manufacturer must reapply to the Notified Body for renewal.

 

Additional Manufacturer Obligations

A new section that builds on the former PPE Directive places additional requirements on manufacturers. These relate to:

  • Sample testing of PPE.
  • PPE Markings.
  • Obsolescence.
  • EU declaration of conformity.
  • Corrective measures for non-conforming PPE.

 

You can download the full article HERE

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