Three different categories are used to define PPE. They are determined according to risk levels, with I being the lowest and III the highest. There have been a number of changes to each of these, brought about as a result of the latest regulation
changes.
In summary, some of the biggest changes include:
In addition to the changes made to categories, a complete new structure has been introduced to define the directives within these sections. These are referred to as “modules”. Currently, there are four modules:
This applies to all Cat I PPE. It’s nothing more than a name change with this one, as it refers to the manufacturer’s self-declaration (as it always has).
This module covers both Cat II and Cat III PPE. It has replaced the Article 10 process. This sees all PPE needing to receive an EU Type Examination. On completion:
This has replaced Article 11A. It relates to the ongoing testing of products throughout their lifecycle. This sees tests being carried out by the notified body at least once a year at random intervals.
If this check results in a problem, the notified body will inform the notifying authority – who will take measure to fix the faults.
This has replaced Article 11B. It requires the manufacturer to maintain a documented quality system. It’s the duty of the manufacturer to lodge an application for an assessment of quality with a single notified body of their choice. These will also be assessed once a year.