From April 21st 2018, the new EU Regulation 2016/425 has been in force, replacing the previous Directive 89/686/EEC and establishing the requirements for the design and manufacture of personal protective equipment (PPE).

WHAT CHANGES

The main difference is that the responsibilities for each step along the supply chain of the personal protective device, from the manufacturer to the distribution network, are defined in a more clear and detailed manner.
BLS's products will not undergo any change as they are already regulated by the previous legislation, for they are Category III PPE.
The change regards the update of the references to the new regulation on all official records related to the device.

DOCUMENTATION CHANGES

Starting from April 21st, the following documents must have an updated reference to the new standard:

  - Technical data sheets (available on the reserved area of the BLS's website)
  - Declarations of conformity (available on the reserved area of the BLS's website)
  - Instructions (Provided with the PPE)

POSSIBLE SCENARIOS

DEVICES PRODUCED BEFORE 21st APRIL 2018
They can still be sold until 20th April 2019.

PURCHASED PRODUCTS CERTIFIED UNDER THE PREVIOUS DIRECTIVE 89/686/EEC
They may continue to be used until their natural expiry date as shown on the label placed on the package.

THE "CE" CERTIFICATE OF THE PRODUCT
It will continue to be valid until 20th April 2023, unless otherwise indicated or if there are changes to the product itself.

 

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