The main changes to be aware of
- The old PPE Directive has been replaced by Regulation (EU) 2016/425 on PPE since April 2018
- A number of types of protection has moved from category II (intermediate) to category III (complex) such as hearing protection and life jackets
- There is now a requirement for manufacturers to supply a declaration of conformity with every item of PPE that is placed on the market
- A five-year certificate of validity is being suggested, bringing the Regulation in line with other similar European requirements
The changes mean that the old Directive has lost its status, and is now re-implemented as a Regulation. This means that the new Regulation will not have to be transposed into each member state’s national law. A directive is a legislative act that sets out an objective that all EU countries must achieve by a given date. It is up to the individual countries however, to decide how this is done. In contrast, a Regulation is a binding legislative act and it must be applied in its entirety across the EU without the need for separate national legislation.
Importers assume the responsibilities of manufacturer
The PPE Regulation is mandatory – covering any type of product that falls within its scope. It is a legal requirement for anyone involved in the PPE industry to comply. Previously, the PPE Directive focused on manufacturers placing products onto the market, but the new Regulation requires the whole supply chain to be involved and, crucially, importers assume the responsibilities of manufacturer.
Patrokles QA Manager – Quality Assurance Done Right
We have recognised that managing all aspects of product compliance requires not just domain knowledge but also a dedicated software solution to streamline day to day activities that quickly spiral out of control if shared file storage, spreadsheets and email are the only tools at your disposal.