On 19 October 2015, the European Commission published new Guidelines on the application of Personal Protective Equipment Directive 89/686/EEC (PPE Directive).
The guidelines were prepared by the Directorate General for Internal Market, Industry, Entrepreneurship and SMEs of the European Commission in collaboration with the Member States and all the relevant stakeholders representing industry, standardization organizations and Notified Bodies. The main objective is to create a common interpretation and a level playing field with regards to the application of the PPE Directive.
The guidance document might constitute a very useful tool for the manufacturers in order to understand how the PPE Directive applies to their products and which steps shall be taken in order to achieve compliancy.
The PPE Directive was published in 1989 and become fully applicable in 1995. This “New Approach” Directive regulates products intended to be worn or held by the user, in order to be protected against hazards either at home, at work or whilst engaging in leisure activities. These products play a major role in the protection of workers and the prevention of work-accidents.
Content of the New Guidelines
The guidance document gives a reasoned overview and explanation of each article of the Directive, and of relevant annexes. In particular it provides a detailed overview of the different conformity assessment routes for the CE Marking of PPE according to their category, namely:
- Category I (“simple design”):
These PPEs are included in an exhaustive list and the manufacturer can declare conformity by means of an EC declaration of conformity only;
- Category II (default category):
PPEs that are not included in the Directive positive lists are subject to an EC type-examination by a Notified Body and an EC declaration of conformity is then produced;
- Category III (so-called “complex design”):
These PPEs are also defined by an exhaustive list and are subjected to EC type-examination and to a specific Quality Assurance procedure involving a Notified Body. An EC declaration of conformity is also produced.
In addition to the above, PPE manufacturers should also be aware that, in line with the New Legislative Framework Decision, the PPE Directive is currently under revision and will be shortly replaced by a Regulation.
As your professional consultant on EU matters, Obelis will be eager to provide you with constant updates and consultancy on the revision of the PPE Directive
Should you require more details on the PPE Guidelines and PPE Legislation Revision, please contact us.