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Since April 21, 2018, Directive 89/686/EEC has been replaced by Regulation (EU) 2016/425 on personal protective equipment (PPE). One of the main changes in the new regulation is that it clearly describes the roles and obligations of all operators in the supply chain.
The different roles in the supply and distribution chain are defined in Regulation (EU) 2016/425 as follows:
Manufacturers of personal protective equipment are logically best informed about the details of the design and manufacturing process. Regulation (EU) 2016/425 therefore states that the obligation to carry out conformity assessment lies solely with the manufacturer. In some cases, this responsibility lies with the importer or distributor. For example, if the PPE is sold under its own brand name or the design is changed in such a way that conformity with the regulation is compromised. In these cases, that party is considered the manufacturer and must assume all associated obligations.
Do you fulfill the role of personal protective equipment manufacturer? If so, you are responsible for the following:
Agents, importers and distributors also have specific obligations regarding conformity assurance of PPE. Do you sell PPE on the European market and wonder what role you have and what obligations are involved? Précon can offer you support on:
Contact us at +31 (0)30 - 65 66 010 or info@precongroup.com. You will then receive our no-obligation quotation.
Subscribe to our newsletter, our monthly look at food and non-food quality management.