General Regulatory Conditions (Medical Devices)

 

These General Regulatory Conditions ("GRCs/MDs") apply to products classified as Medical Devices (within the meaning of Art. 2 No. 1 of the MD Directive (EU) 2017/745) including accessories and whose manufacturer is Paul Hartmann AG, Paul-Hartmann-Straße 12, 89522 Heidenheim, Germany, or one of its group companies ('Products').

 

The GTCs/MDs 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/MDs 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/MDs cover the activities of Dealers with regard to the acquisition, ownership and supply or provision of products on the market.

 

The GRCs/MDs apply without prejudice to Hartmann's terms of delivery and payment and are applicable to all products which the Dealer provides for the market as from 26th May 2020. The Dealer acknowledges the validity of these GRCs/MDs by placing the order for the products or by accepting the products. These GRCs/MDs also apply to all future transactions concerning products with the Dealer.

 

1.         If the Dealer becomes aware of any complaints, suspected risks and/or cases of non-conforming products, (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/lot number, UDI if applicable, 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 same obligation to provide information as under Clause 1 shall apply regardless of whether the Dealer has already made the products concerned available on the market or not, if the Dealer is of the opinion or has reason to believe that a product delivered to him is a non-conforming product and/or a product poses a serious risk and/or is a counterfeit product.

 

3.         The understanding of the terms "complaints", " events", "conformity", " non-conforming product", "serious risk" and "counterfeit product" is governed by the Medical Devices Directive (EU) 2017/745.

 

4.         The Dealer shall keep systematic records (so-called "registers") in which at least all complaints received from the market and all cases of non-conforming products are to be recorded. The register shall contain the information referred to in Clause 1 [a], [b], [c], [d]. The Dealer shall grant Hartmann access to the register and shall provide Hartmann with copies of the register for a given reason and upon request.

 

5.         In addition to the register, 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/lot number, UDI if applicable), [b] recipient, [c] quantity, [d] date of shipping, [e] own storage location, if not yet shipped. The Dealer shall keep the traceability records for ten years after the last product has been made available on the market.

 

6          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; Hartmann may take over replying to the official request. The Dealer shall also inform Hartmann immediately and consult with Hartmann, if he receives notifications or requests from the authorities that corrective actions (such as recalls or returns) are to be implemented or if free-of-charge product samples are to be supplied.

 

7          If the Dealer believes or has reason to believe that there is a severe risk associated with a product or that it is a non-conforming or counterfeit product and he may therefore not provide the product to the market, 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. In connection with a possible suspension of the provision of products on the market and/or information to authorities, the Dealer shall consult with Hartmann in advance with regard to the suspension or information.

 

8.         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 group) 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. Without prejudice to the foregoing, the Dealer shall be willing to provide the manufacturer of the products with information (such as, for example, feedback from product users) as provided for in the manufacturer's PMS (Post-Market Surveillance) plan.

9.         While products are under the control of the Dealer, the Dealer shall ensure that the storage and transport conditions comply with the manufacturer's specifications; Hartmann may, if necessary, be instructed by the manufacturer to substantiate such specifications.

 

10.       When making products available on the market, the Dealer must always observe the applicable regulatory requirements (in particular the Medical Device Directive (EU) 2017/745) and act with the necessary diligence.

 

11.       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 provided by the manufacturer, [c] are accompanied by identification markings or labels (in the meaning of Section 23.1 of the Medical Device Directive), [d] are accompanied by instructions for use in the national language(s), [e] in the case of imported products are accompanied by information on the importer (name/company, address). The Dealer may use a representative sampling procedure for checking the above requirements [a] to [d]. Hartmann shall ensure that copies of the declarations of conformity in accordance with the above requirement [b] are made available to the Dealer.

 

12.       The Dealer is at liberty to provide the economic players responsible for the products with legally required information, to grant access to registers, 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/MDs.