General Terms and Conditions of Sale HC
The following terms of delivery and payment apply to all orders of products placed with HC – Healthcare Consulting GmbH (Registered Office: Akkermanstrasse 6, 73035 Goeppingen, Germany) or placed with HC – Medical Solutions GmbH (Registered Office: Sandgruebe 23, 3257 Grossaffoltern, Switzerland):
§ 1 Applicability
(1) These terms and conditions of sale apply exclusively to contractees, legal entities under public law, or common funds under public law within the context of § 310 Section 1 BGB. We shall only recognize terms and conditions of the purchaser that are contrary to or deviate from our terms and conditions of sale if we explicitly agree to their validity in writing.
(2) These terms and conditions of sale also apply to all future transactions with the purchaser, in so much as it concerns legal transactions of a related nature.
§ 2 Offer and Conclusion of Contract
(1) Provided an order is to be regarded as an offer in accordance with § 145 BGB, we may accept it within two weeks.
(2) If we submit an offer, it is not binding, unless otherwise specified in writing. The contract is concluded following the acceptance of our offer only after we have confirmed the order in writing or begun with its fulfillment and the delivery of the purchase items ordered.
(3) The products offered by HC and their properties can be found in our respective proposal and our order confirmation / acceptance. In all other respects, the specifications of the manufacturer apply to the properties of the products, their application, etc., as it generally appears in the instruction manual or in any additional product information. These specifications are binding.
§ 3 Transferred Documents
For all documents transferred to the purchaser in the relation to the placing of an order, such as calculations, designs, etc., we reserve the right of ownership and copyright. These documents are not to be made accessible to third parties unless we give the purchaser our express written consent to do so. Provided we do not accept the purchaser’s offer within the period of § 2, these documents are to be returned to us immediately.
§ 4 Price and Payment
(1) Unless otherwise agreed in writing, our prices apply according to the respective offer / order confirmation ex works (EXW) excluding packaging and including value-added taxes at an applicable rate. Costs for packaging will be invoiced separately.
(2) Payment of the purchase price must be made exclusively to the account listed overleaf. The deduction of a discount is only permissible with a special written agreement.
(3) If nothing else is to be agreed upon, the purchase price is to be paid within 7 days following delivery. Any interest incurred for default will be charged at a rate of 4.1 % over the respective prime rate p.a. We reserve the right to claim higher damages for default.
(4) Unless a fixed price agreement has been made, we reserve the right to make reasonable price adjustments due to changes in wage, material, and distribution costs for deliveries made 3 months or more following the conclusion of the contract.
§ 5 Right of Retention
The purchaser shall only be authorized to exercise a right of retention insomuch as the counterclaim is based upon the same contractual relationship.
§ 6 Delivery Time
(1) The commencement of the delivery period stated by us is subject to the timely and proper fulfillment of the purchaser’s obligations. We reserve the right to plea non-fulfillment of the contract.
(2) If the purchaser comes in default of acceptance or culpably violates other cooperation obligations, we are then entitled to demand compensation for damages thereby to the extent we incurred, including any additional expenses. We reserve the right to make further claims. Provided that the above prerequisites are met, the risk of an accidental loss or an accidental deterioration of the purchase item shall go to the purchaser at the point in time in which the purchaser falls into default of acceptance or payment.
(3) Further legal claims and rights of the purchaser due to a delay in delivery remain unaffected.
§ 7 Transfer of Risk during Shipment
If the goods are shipped to the purchaser at the request of the purchaser, the risk of an accidental loss or an accidental deterioration of the purchase item shall transfer to the purchaser, at the latest, upon leaving the works/warehouse. This applies, regardless of whether the goods are shipped from the place of fulfillment or who pays the freight charges.
§ 8 Retention of Title
(1) We shall retain ownership of the delivered goods until the complete payment of all stipulations from the delivery contract. This also applies to all future deliveries, even if we do not always explicitly refer thereto. We are entitled to take back the purchase item if the purchaser acts in violation of contract.
(2) The purchaser is obliged, as long as the ownership has not yet been transferred, to treat the purchase item appropriately and to store or transport it in accordance with the manufacturer’s instructions. The purchaser is particularly obliged to sufficiently insure the purchase item at replacement value and at their own expense against damages from theft, fire, and water. If maintenance and inspection work must be done, the purchaser shall complete this in a timely manner and at their own expense. As long as ownership has not yet been transferred, the purchaser must inform us immediately in writing if the delivered item is seized or if it is subject to other interventions by third parties. Provided that the third party is not in a position to compensate us for the judicial and extrajudicial costs of a legal action pursuant to § 771 ZPO / Art. 242 SchKG (separation), the purchaser is thereby liable for the loss we have incurred.
(3) The processing or transformation of the purchase item by the purchaser must always take place in our name and on our behalf. In this case, the purchaser’s reversionary interest of the purchase item shall continue in the transformed object. If the purchase item is processed with other items not belonging to us, we shall acquire co-ownership of the new item in the ratio of the objective value of our purchase item to the other processed items at the time of processing. The same applies in the case of mixing. If the mixing occurs in such a way that the purchaser’s item is seen as the main item, it is deemed, as agreed, that the purchaser proportionately transfers co-ownership to us and keeps the sole ownership or co-ownership thus created for us, in safety. For the security of our claims against the purchaser, the purchaser also transfers such claims to us, which accrue as the result of the connection of reserved goods with real property by a third party; we already accept this assignment now.
(4) We are obliged to release the securities to which we are entitled at the request of the purchaser, insofar as their value exceeds the claims to be secured by more than 20 %.
§ 9 Warranty, Notice of Defects, and Recourse
(1) Warranty rights of the purchaser presuppose, that the purchaser has properly and promptly complied with its obligations of inspection and notice of defects pursuant to § 377 HGB.
(2) Defect claims lapse in 12 months following the delivery of our goods to the purchaser. For damage claims from intent and gross negligence as well as injury to life, body, and health, based on the user’s intentional or negligent breach of contract, the statutory limitation period applies. Our approval must be obtained prior to returning any goods.
(3) If despite all the care taken, the delivered goods should still show a defect, which already existed at the time of the transfer of risk, we may, subject to the timely notification of defects, at our own discretion, either repair the goods or deliver replacement goods. We shall always be given the opportunity to rectify the defect within a reasonable period of time. Claims of recourse remain unaffected by the above provision, without restriction.
(4) If the subsequent fulfillment fails, the purchaser can– irrespective of any claims for damages – withdraw from the contract or reduce the compensation.
(5) Defect claims shall not exist only due to minor deviation from the agreed condition, insignificant impairment of usability, natural wear or tear like damages following the transfer of risk as a result of improper or careless handling or improper implementation, transport, storage, excessive stress, unsuitable operating equipment, or arising on account of special outside influences that are not provided in the contract or the enclosed product description / instruction manual. If the purchaser or third parties carry out improper repairs or modifications, there shall also be no defect claims for these and the resulting consequences.
(6) Claims by the purchaser for expenses required for the purpose of rectification, in particular, transport, travel, labor, and material costs, are excluded insofar as the expenses increase, because the goods delivered by us have been subsequently brought to a place other than the purchaser’s branch office, unless the transfer is in accordance with its intended use.
(7) The purchaser’s right of recourse against us shall only exist insofar as the purchaser has not entered into any agreements with their customer beyond the legally mandatory claims of defects. Furthermore, the extent of the purchaser’s right of recourse against the supplier applies in accordance with paragraph 6.
§ 10 Liability
(1) Our liability for damages that are caused by us, our lawful representatives, or vicarious agents, is limited to intentional, deliberate, or grossly negligent breaches of contract as well as direct damages foreseeable at the time of the conclusion of the contract.
(2) Any further liability, as well as liability for simple negligence and liability for auxiliary persons, shall be excluded, insofar as it is lawfully permissible.
§ 11 Obligations of the Purchaser
(1) The purchaser is obliged to inform us immediately about suspected incidents in relation to a product that has been obtained from us.
(2) The purchaser is furthermore obliged to comply with any legal documentation, registration, information, and collaboration obligations in accordance with applicable law. Further relevant information on the implementation of medical device regulations in the EU and Switzerland can be found in the addendum to these terms and conditions of sale.
§ 12 Other
(1) These terms and conditions of sale and all legal relations between the parties are subject to the law of the Federal Republic of Germany, excluding the United Nations Convention on Contracts for the International Sale of Goods (CISG).
(2) The registered office of HC – Healthcare Consulting GmbH in Germany is the place of fulfillment, exclusive place of jurisdiction, and place for all disputes arising from this contract, unless otherwise stated in the order confirmation.
(3) All other written agreements between the parties shall override the terms and conditions of sale in the event of a dispute.
(4) We reserve the right to update these terms and conditions of sale without prior notice. The currently valid version applies and can be accessed via the following link: […].
Addendum to the General Terms & Conditions of Sale
Implementation of the Obligations under the European Medical Devices Ordinance (MDR) and the revised Swiss Medical Devices Ordinance (MepV)
As of the 26th of May 2021, the MDR in the EU area and the revised MepV in Switzerland will be fully and directly applicable. The MepV still refers largely to EU law, i.e., the MDR, whereby under Swiss law, some transitional provisions to the EU relationship still apply.
The aforementioned laws bind manufacturers, importers, and distributors as well as other players, and oblige them to fulfill various specifications. Extensive obligations will be imposed on manufacturers, importers, and distributors in particular, but also healthcare facilities, which affect them individually, but can only be fulfilled in cooperation.
The present addendum to the general terms and conditions of sale should serve as a tool to guarantee the compliance of regulatory obligations of all involved parties, to coordinate them, efficiently implement them, and contribute to the safety of the supply of medical devices. This addendum applies to all ongoing and future business relationships in reference to the delivery of medical devices by HC – Healthcare Consulting GmbH, or the HC – Medical Solutions GmbH (hereafter: “HC“).
As a part of the general terms and conditions of sale, this addendum is an integral component of the contract. The addendum is not intended to be an all-conclusive list or regulation of the existing obligations according to applicable law. For the responsibilities and their implementation, the current wording of the MDR, or the MepV, corresponding to the implementing provisions and any possible explanations or information sheets published thereof by responsible authorities shall be authoritative.
1. Role of HC
HC is not a manufacturer of medical devices and also does not act as an authorized representative. HC is basically an importer and/or distributor in regard to the distribution of medical devices in the EU or in Switzerland.
2. Role of the Purchaser
The purchaser (HC client) usually falls into either the role of the distributor and/or the healthcare facility. However, it is the obligation of the purchaser, and not the responsibility of HC, to correctly define their role according to applicable law and observe the respective obligations.
3. Obligations of all Economic Players and Health Care Facilities
All economic players (i.e. manufacturers, authorized representatives, importers, and distributors) have various mutual information obligations, especially with regard to the conformity of medical devices and potential hazards either arising from them or are reported to the economic players.
All economic players have a mutual obligation of cooperation. They are likewise obliged, to collaborate with the responsible authorities and implement any possible corrective actions in order to establish the conformity of the product, withdraw it from the market, or to recall it.
The economic players collaborate in particular to ensure the traceability of the product. In accordance with MepV and Art. 47c HMG, all economic players must document their supply sources and customers and disclose them to the responsible authority (Swissmedic) upon request.
4. Obligations of the Manufacturer
The manufacturer of medical devices is, among other things, obliged to manufacture products for the EU market / Swiss market only in conformity with the MDR / MepV and to therefore guarantee that. The manufacturer must label their products in accordance with the specifications of the MDR / MepV.
The manufacturer must set up a quality / risk management system to document, to apply, and to maintain. Subsequently, they have the main obligations regarding market surveillance and vigilance. The manufacturer is, among other things, obliged to have a system for recording and reporting incidents and safety corrective actions in the field.
If the manufacturer has their registered office in foreign EU countries, in other words, outside of Switzerland, they shall designate an authorized representative based in the EU (“EC-REP”), in other words, based in Switzerland (“CH-REP”).
5. Obligations of the Importer
The importer is, among other things, obliged to check medical devices for the presence of the conformity mark (typically CE), the conformity declaration, the instruction manual in the necessary languages, and the application of the UDI by the manufacturer (if applicable), as well as the product labeling before placing them on the market. The importer must provide their name and address on the product, its packaging, or an enclosed document. If non-conformities are found, the importer shall not place the product on the market and shall inform the manufacturer / authorized representative.
The importer must keep a register of the complaints of non-conforming products and recalls, as well as withdrawals. Importers, who receive complaints and reports from healthcare professionals, patients, users, healthcare facilities, etc. about suspected incidents in relation to a product that they have already placed on the market, must forward this information to the manufacturer or their authorized representative. If the importer believes or has reason to believe that a product may pose a serious danger or that it is a counterfeit product, they shall inform the responsible authority.
Medical devices are to be transported and stored by the importer according to the manufacturer’s instructions.
6. Obligations of the Distributor
The distributor is, among other things, obliged to check medical devices for the presence of the conformity mark (i.e. CE), the conformity declaration, the product information, and the application of the UDI by the manufacturer (if applicable) at least on a random basis before placing on the market. The specification of the importer’s name and address shall always be checked. If non-conformities are found, the distributor shall not place the product on the market but shall inform the importer and the manufacturer / authorized representative.
The distributor must keep a register of the complaints of non-conforming products and recalls, as well as withdrawals. Distributors who receive complaints and reports from healthcare professionals, patients, users, healthcare facilities, etc. about suspected incidents in relation to a product that they have already placed on the market, must forward this information to the manufacturer or their authorized representative and the importer. If the distributor believes or has reason to believe that a product may pose a serious danger or that it is a counterfeit product, they shall inform the responsible authority.
Medical devices are to be transported and stored by the distributor according to the manufacturer’s instructions.
7. Obligations of Healthcare Facilities
Healthcare facilities have important information and reporting obligations in relation to the identification of non-conformities, incidents, or dangers of medical devices. In order to enable economic players to fulfill their information and reporting obligations, healthcare facilities are obliged to cooperate with them and report to them (i.e. especially to the supplier) any incidents in relation to medical devices obtained from them.
In accordance with MepV and Art. 47c HMG, healthcare facilities must also document their supply sources and customers and disclose them to the responsible authority (Swissmedic) upon request.
Healthcare facilities are obliged to collect and to store the UDI from implantable class III devices.
8. Implementation between the Contracting Parties
In terms of the obligations discussed, the purchaser (HC client) is obliged to comply to HC, their regulatory obligations, particularly their information and documentation obligations in the context of traceability and monitoring of medical devices, so that HC can also comply with its information and documentation obligations in this context. Specifically, this means:
Traceability
The purchaser shall ensure and warrant to HC, that it is possible to address all recipients of medical devices obtained from HC, in order to provide them with relevant safety information and instructions from the respective manufacturers concerned, from the responsible authorities, or consult them appropriately concerning this matter.
The purchaser shall also ensure that this information is available to HC even after the purchaser has terminated business or in the event of their insolvency.
Product Observation
The purchaser is obliged:
- to document, store, and keep up to date the experiences, findings, and other information about the products obtained from HC;
- implement appropriate procedures for receiving and storing such information; as well as
- keep a provision for cases of termination of business or insolvency.
The purchaser must provide this information to HC per request or if the occasion requires it (for example, an incident) to be available without request.
Marketing / Application
With regard to product information on medical devices (including those relating to their properties, handling, application, storage, marketing, consultation, performance, or further attributes), reference is made to the specifications of the manufacturer, which are shown primarily in the instruction manual. These are binding. The purchaser is obliged to observe these when using or marketing the product.
When advertising, there is a general obligation to only use advertising materials authorized by the manufacturer.
