Personal protective equipment is subject to Regulation (EU) 2016/425 and is therefore directly affected by the obligation to affix a CE marking and to undergo the CE conformity assessment procedure. Placing on the market without having completed the conformity assessment procedure and affixing the CE marking is not possible within the EU.
The manufacturer of the personal protective equipment is responsible for the CE marking. If the manufacturer is not located in the European Union, he can appoint an authorized representative in the EU. If he does not do so, the importer is responsible for CE conformity as the person placing the product on the EU market.
PPE or not?
First of all it is necessary to assess which products are actually personal protective equipment and fall under the definition of the PPE regulation. In addition, it must be determined whether the PPE is of categories I to III, since different requirements are sometimes placed on these categories. Many questions of delimitation make these steps difficult.
Is a mouth-nose cover protective equipment or a hygiene article not covered by the regulation? Do simple dishwashing gloves fall under the PPE regulation? Where do the medical devices overlap and how should unique items adapted to an individual user be considered?
As a manufacturer or importer, you are responsible for compliance with the provisions of the PPE Ordinance. An important element of this is the involvement of a (notified) Notified Body, which must carry out a type examination for PPE from category II upwards. For category III PPE, a product-related or production-securing inspection must also be carried out by a competent test centre at the manufacturing plant. The requirements are divided into product tests according to the relevant standard and subsequent certification and surveillance audits by the Notified Body.
For simple PPE, no involvement of a Notified Body is required. The manufacturer is required to install a suitable internal production control system and is responsible for issuing the declaration of conformity. It is advisable to apply valid standards and to meet the requirements contained therein. Thus, the manufacturer or importer can assume that the product is safe with regard to the properties regulated in the standard.
We at asseso can help you in individual areas or oversee the entire process. We check existing test reports or commission new ones, compile the technical documentation and marking elements and prepare your declaration of conformity.