Respirex International

New PPE Regulation (EU) 2016/425

With the deadline for the new Personal Protective Equipment (PPE) Regulation (EU) 2016/425 just over 3 months away, we thought we’d review what has changed and how this affects the manufacture and supply of PPE.

The Directive is now over 20 years old and is being superseded by a new PPE Regulation (EU) 2016/425. This is to reflect the changes in technology and the way in which PPE is brought to market. This new regulation came into force on 21st April 2018 and will be in full effect from 21st April 2019. There is currently a transition period where both the new regulation and the old directive are applicable.

Timeline for the PPE Regulation (EU) 2016/425
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(Source: BSI PPE Directive and PPE Regulation (EU) 2016/425 Whitepaper)

The PPE Regulation is mandatory and included in the changes are new obligations for importers and distributors of PPE. Importers, distributors and anyone else involved in the supply chain must ensure that PPE meets the standard requirements and keep all relevant documents for at least 10 years.

Main Changes in the new PPE Regulation (EU) 2016/425

  • Issuing a Declaration of Conformity with each item of PPE, or at least a link to where it can be obtained
  • A compulsory maximum five-year CE certificate validity
  • The need for manufacturers to place their name and address on the product
  • The need to a produce risk assessment in the technical file
  • Moving hearing protection and life jackets from Category II to Category III PPE
  • Bespoke PPE is now covered in the Regulation
  • New responsibilities outlined for importers and distributors

Transitional Period

For a transitional period of 1 year (21st April 2018 until 20th April 2019) both the new regulation 2016/425 and the old directive are valid. This means that PPE manufactured in accordance to Directive 89/686/EEC can still be added to the market up until 21st April 2019. CE Certificates which have been issued under the old directive will remain valid until 21st April 2023 (unless they expire before this date).

From 21st April 2019 products added to the market must hold a Declaration of Conformity to the new regulation, must include the correct markings (manufacturers name and address), and must be CE certified to the latest harmonised standard.

Respirex are working hard to ensure all of our products are compliant by the 21st April 2019 and all declarations of conformity to the regulation can be downloaded from www.respirexinternational.com/doc

If you have any questions relating to the certification of PPE please contact us.

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