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General Regulatory Conditions | Personal Protective Equipment

Last updated: 1st April 2019

General Regulatory Conditions

Personal Protective Equipment

These General Regulatory Conditions ("GRCs/PPE") apply to products classified as Personal Protective Equipment (PPE) within the meaning of Art. 3 No. 1 of the PPE Directive (EU) 2016/425) and whose manufacturer is Paul Hartmann AG, Paul-Hartmann-Straße 12, 89522 Heidenheim, Germany, or one of its group companies ('Products').

The GTCs/PPE are provided by Paul Hartmann AG if it sells products to the Dealer itself, or by one of its group companies if these sell products to the Dealer (collectively "Hartmann").

The GRCs/PPE apply to "Dealers", i.e. natural or legal persons in the supply chain who make products available until they are put into service on the market, without themselves being manufacturers or importers of such products.

The GRCs/PPE cover the activities of Dealers with regard to the acquisition, ownership and supply of products.

The GRCs/PPE apply without prejudice to Hartmann's terms of delivery and payment. The Dealer acknowledges the validity of these GRCs/PPE by placing the order for the products or by accepting the products. These GRCs/PPE also apply to all future transactions concerning products with the Dealer.

1. If the Dealer becomes aware of any complaints, reports of suspected risks and/or cases of non-conforming products, in particular failure to comply with basic health and safety requirements (collectively "special events") with regard to products made available on the market by the Dealer, the Dealer shall inform Hartmann of this without delay and shall forward at least the following information to Hartmann - blanking personal data: [a] Product concerned (by article/batch number, quantity), [b] Nature and background of the special event, [c] Current known whereabouts of the product concerned, [d] Nature and extent of any reported damage to health. Immediate notification must be given no later than 36 hours after the special event becomes known; if necessary, detailed reports must be submitted later to Hartmann.

2. The meaning of the terms "complaints", "risks", "non-conforming product", "basic health protection and safety requirements" is based on the PPE Directive (EU) 2016/425.

3. The Dealer shall keep systematic records ensuring the traceability of the products delivered to the Dealer and made available on the market by the Dealer ('traceability records'). Hereby the Dealer shall document at least: [a] type of the product (according to article/batch number), [b] recipient, [c] quantity, [d] date of shipping, [e] own storage location, if not yet shipped.

4. Insofar as the Dealer receives requests from authorities for documents or information to prove the conformity of products, the Dealer shall forward these requests immediately to Hartmann; the Dealer shall consult with Hartmann before responding to the official request. The Dealer shall also inform Hartmann immediately if he receives notifications or requests from the authorities that corrective actions (such as recalls or returns) are to be implemented.

5. If the Dealer believes or has reason to believe that there is a risk associated with a product made available on the market by him or that it is a non-conforming product and he must therefore ensure that corrective actions are to be taken, the Dealer shall inform Hartmann immediately of the relevant occurrence; whereby, the Dealer shall specifically explain to Hartmann which specific circumstances lead him to the belief or assumption. The same applies if the Dealer intends to inform the authorities of the occurrence for the aforementioned reasons. The Dealer shall only implement preventive or corrective actions (such as product recalls or returns) in consultation with the manufacturer.

6. Insofar as the manufacturer of products takes a preventive or corrective action or implements such an action in cooperation with the authorities (including returns, recalls, sending of so-called field safety notices), the Dealer shall provide Hartmann (in its capacity as manufacturer or as economic player in the manufacturer's warehouse) with the necessary support; this shall occur in particular by the Dealer immediately identifying the shipment routes of the affected products by means of his traceability records and by forwarding notifications prepared by the manufacturer (such as field safety notices) to the offices or own customers to whom he has supplied the products.

7. While products are under the control of the Dealer, the Dealer shall ensure that the storage and transport conditions do not impair the conformity of the products with the basic health and safety requirements and comply with the manufacturer's notified specifications; Hartmann may, if necessary, be instructed by the manufacturer to substantiate such specifications.

8. When making products available on the market, the Dealer must always observe the applicable regulatory requirements (in particular the PPE Directive (EU) 2016/425) and act with the necessary diligence.

9. Before making a product available on the market, the Dealer shall verify compliance with the following requirements: the product(s) [a] bear CE markings, [b] correspond with the declarations of conformity attached by the manufacturer or provided online, [c] are accompanied by identification markings (e.g. batch number), [d] instructions and information of the manufacturer are attached in the national language(s), [e] in the case of imported products are accompanied by information on the importer (name/company, address). Hartmann shall ensure that copies of the declarations of conformity in accordance with the above requirement [b] are made available to the Dealer unless these have been made available online.

10. The Dealer is at liberty to provide the economic players responsible for the products with legally required information, to make notifications, or to forward reports to them and/or to cooperate with them, for example, in the event that - due to the difference of Hartmann to such economic players - such activities of the Dealer are not already outlined by these GRCs/PPE.