General Terms and Conditions of Sale and Delivery (Europe)

HC – Healthcare Consulting GmbH, Akkermanstraße 6, 73035 Göppingen, Germany
(hereinafter “HC”)

These Europe-wide General Terms and Conditions of Sale and Delivery (“GTC Europe”) shall apply to all deliveries and services provided by HC to customers domiciled in a member state of the European Union (EU) or the European Economic Area (EEA) (hereinafter collectively “Europe”), unless otherwise agreed in writing in an individual case.

§ 1 Scope, Contracting Party, Precedence of our Terms

These GTC Europe apply to all contracts for deliveries and services from HC to customers who are entrepreneurs within the meaning of Section 14 of the German Civil Code (BGB) (i.e., in particular, hospitals, clinics, other healthcare facilities, companies, and public-law entities). HC does not conclude contracts with consumers on the basis of these GTC Europe.
The customer’s sole contracting party is HC.
Any terms and conditions of the customer that conflict with or deviate from these GTC Europe shall not apply, unless HC expressly agrees to their validity in writing. This shall also apply if HC carries out the delivery without reservation in the knowledge of conflicting or deviating conditions.
References by the customer to its own purchasing conditions (e.g., in orders, portals, order confirmations) and the mere reference thereto by HC (e.g., in delivery notes, shipping notifications, or invoices) shall not constitute acceptance of the customer’s terms and conditions.
These GTC Europe, in their currently valid version, shall also apply to all future business transactions with the same customer without any need for HC to refer to them again.
Where these GTC Europe require the written form, transmission by email shall also suffice.

§ 2 Offer and Conclusion of Contract

Offers from HC are subject to change and non-binding, unless they are expressly designated as binding or contain a specific acceptance period.
An order placed by the customer shall be deemed a binding offer to conclude a contract. HC may, at its discretion, accept this offer by:

• written or electronic order confirmation,
• delivery of the goods, or
• issuance of an invoice.

The nature and scope of the owed deliveries and services shall be determined by HC’s offer or the order confirmation. In case of discrepancies, the order confirmation shall prevail.

§ 3 Product Information, Regulatory Roles (MDR / IVDR / National Law)

The properties of the products are determined by the respective product description, technical specifications, and the manufacturer’s information, in particular the instructions for use, labelling, and other product documentation. This information is binding for application, storage, transport, and disposal.
Medical devices and in vitro diagnostic medical devices may only be used, stored, transported, applied, and disposed of in accordance with the manufacturer’s instructions and applicable legal regulations. This includes, in particular, Regulation (EU) 2017/745 on medical devices (MDR), Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), and the respective national implementing provisions of the EU/EEA member states.

Regulatory Roles:
HC is the customer’s contracting party and supplier and generally acts as a distributor within the meaning of the MDR/IVDR in the European Union and the EEA. In this role, HC shall fulfil its obligations under the MDR/IVDR and applicable national law (in particular, sample checks of labelling and instructions for use, any registration obligations under national law, documentation and retention obligations, and required notifications to the competent authorities), insofar as they apply to HC.
This regulatory role does not alter the fact that the purchase contract is concluded exclusively with HC.
The customer is solely responsible for correctly determining its own role (e.g., healthcare institution, distributor, reseller) under the MDR/IVDR and applicable national law and for complying with the associated legal obligations.

§ 4 Prices, Payment Terms, Default

Unless otherwise agreed in writing, all prices are quoted in Euro (EUR) net, plus the applicable statutory value-added tax (VAT) and any other public charges.
Unless otherwise agreed, deliveries within Europe shall be made in accordance with Incoterms® 2020 DAP (“Delivered At Place”) to the delivery address specified by the customer. The costs for standard packaging and standard transport are included in the price in this case.
For orders with a net goods value of less than EUR 500 per delivery, the delivery shall also be made in accordance with Incoterms® 2020 DAP to the delivery address specified by the customer; in such cases, HC may charge a flat fee for freight and handling costs according to the currently valid conditions.
Deviating delivery terms (in particular EXW – Ex Works, FCA – Free Carrier, or other Incoterms®) may be agreed separately, especially for deliveries to dealers, distributors, or logistics partners. In such cases, the allocation of costs and the transfer of risk shall be governed by the delivery terms expressly stated in the offer or order confirmation.
Unless otherwise agreed, invoices are payable without deduction within 20 days of the invoice date. Deviating payment terms may be agreed individually and must be expressly stated in the offer, contract, or order confirmation. Discounts, bonuses, or rebates shall only be granted if they have been expressly agreed and all payments are made on time.
In the event of a payment default, HC is entitled to charge default interest at the statutory rate (in particular pursuant to Section 288 of the German Civil Code, BGB) as well as reasonable reminder and collection costs. HC is also entitled to withhold further deliveries until all outstanding amounts have been paid in full.
The customer shall only be entitled to a right of retention or set-off to the extent that its counterclaims are undisputed, have been finally determined by a court, or have been acknowledged in writing by HC.

§ 5 Delivery, Delivery Times, Transfer of Risk

Delivery times are only binding if they are expressly designated as such by HC. They shall commence at the earliest on the date of the order confirmation and after all technical and commercial questions have been clarified and any agreed advance payments have been received.
HC is entitled to make partial deliveries, provided this is reasonable for the customer and does not place the customer at an unreasonable disadvantage.

Standard DAP:
Unless otherwise agreed in writing, delivery within Europe shall be made in accordance with Incoterms® 2020 DAP to the delivery address specified by the customer. In this case, the risk of accidental loss or accidental deterioration of the goods shall pass to the customer as soon as the goods are made available for unloading at the agreed place of destination.

Deviating Delivery Terms (e.g., EXW/FCA):
If deviating delivery terms (in particular EXW, FCA, or other Incoterms®) are agreed in the offer or order confirmation, the transfer of risk shall be determined by the corresponding Incoterms® 2020 rules. In such cases, the customer shall bear the risks of transport, delay, damage, or loss from the agreed point of risk transfer.

If the customer is in default of acceptance or breaches its duties of cooperation, HC is entitled to store the goods at the customer’s expense and risk and to demand compensation for the additional expenses incurred as a result. HC’s statutory rights shall remain unaffected.

§ 6 Retention of Title

The delivered products shall remain the property of HC until all claims arising from the business relationship with the customer have been paid in full.
In countries where an extended or expanded retention of title is subject to special formal requirements or requires registration, HC is entitled to make all necessary declarations and take all necessary actions. The customer undertakes to support HC in this regard and to provide all necessary declarations.
The customer shall handle the products with care during the period of retention of title, store them properly (including compliance with temperature and storage requirements), and insure them sufficiently at its own expense against common risks (theft, fire, water damage, etc.).
Pledging or transferring the goods subject to retention of title as security is not permitted. In the event of seizures or other interventions by third parties, the customer must inform HC immediately in writing.

§ 7 Inspection and Notification of Defects

The customer is obliged to inspect the delivered products immediately upon receipt and to notify HC in writing of any defects, quantity discrepancies, or incorrect deliveries without undue delay.
Obvious defects must generally be reported within 5 working days of receipt of the delivery; hidden defects must be reported immediately upon discovery. If the customer fails to provide timely notification, the products shall be deemed to have been approved, unless the defect was hidden.
Products subject to a complaint must be stored properly until the matter is resolved and may not be resold or processed without HC’s consent.

§ 8 Warranty

In the case of a justified and timely notification of a defect, HC shall, at its own discretion, either provide a replacement delivery or remedy the defect. If the remedy or replacement delivery fails, the customer may, in accordance with the applicable statutory provisions, demand a reasonable reduction of the purchase price; further rights shall be governed by § 9 (Liability).
A defect shall not be deemed to exist, in particular, in the case of:

• only insignificant deviation from the agreed quality,
• normal wear and tear,
• damage resulting from improper storage, transport, or application,
• non-compliance with the manufacturer’s instructions or legal regulations.

Warranty claims shall become time-barred in accordance with the periods specified in the offer or order confirmation; if no period is specified, the warranty period shall be 12 months from delivery. Mandatory longer limitation periods under applicable public law shall remain unaffected.

§ 9 Liability

HC shall be liable in accordance with the applicable mandatory statutory provisions for damages resulting from an intentional or grossly negligent breach of duty by HC, its legal representatives, or its vicarious agents.
For slight negligence, HC shall only be liable for the breach of essential contractual obligations, the fulfilment of which is a prerequisite for the proper execution of the contract and on the observance of which the customer may regularly rely. In this case, liability shall be limited to the typically foreseeable damage at the time of the contract conclusion.
Liability for loss of profit, indirect damages, and consequential damages (in particular, production downtime, business interruption, loss of data) is excluded to the extent permitted by law.
Liability under mandatory product safety regulations, applicable product liability standards, and for damages resulting from injury to life, limb, or health shall remain unaffected.

§ 10 Customer’s Obligations (Medical Devices / Traceability)

The customer undertakes to independently fulfil all obligations incumbent upon it under the MDR/IVDR and the relevant national implementing provisions. The customer is solely responsible for correctly determining its role (e.g., healthcare institution, distributor, reseller) and, in particular, for fulfilling the following obligations:

• proper storage, transport, and application of the products in accordance with the manufacturer’s instructions,
• documentation of supply sources and recipients to ensure complete traceability,
• recording and retention of experiences, complaints, and incidents related to the products.

The customer is obliged to inform HC immediately in writing of any suspected incidents, safety risks, or non-conformities in connection with the products supplied by HC and, where legally required, to report them to the competent authorities.
The customer shall ensure that in the event of field safety notices, field safety corrective actions, or recalls, all affected recipients can be specifically identified and informed. The customer undertakes to cooperate actively with HC, the manufacturer, and the competent authorities in the implementation of such measures.
Upon request, the customer shall provide HC with all information required for traceability, market surveillance, field safety notices, recalls, and official investigations in a suitable format.
For the promotion and marketing of the products, only the information provided by the respective manufacturer (in particular, the instructions for use) shall be binding. The customer may only use promotional materials that are consistent with the manufacturer’s information and applicable legal requirements.

§ 11 Confidentiality and Data Protection

Business and trade secrets, confidential information, and the content of offers and contracts must be treated confidentially by the customer and may only be disclosed to third parties with the prior written consent of HC, unless there is a legal obligation to disclose.
HC processes personal data in accordance with the applicable data protection regulations, in particular the General Data Protection Regulation (GDPR) and the relevant national data protection laws. Further details may be regulated in separate data protection notices.

§ 12 Applicable Law, Jurisdiction, Severability Clause

All legal relationships between HC and the customer to which these GTC Europe apply shall be governed by the laws of the Federal Republic of Germany, in their currently valid version, to the exclusion of the United Nations Convention on Contracts for the International Sale of Goods (CISG).
The exclusive place of jurisdiction for all disputes arising from or in connection with contracts between HC and the customer shall be, to the extent permitted by law, the registered office of HC (Göppingen, Germany). Mandatory statutory places of jurisdiction shall remain unaffected.
Should any provision of these GTC Europe or the contract be or become invalid or unenforceable, the validity of the remaining provisions shall not be affected. The parties undertake to agree on a valid provision that comes as close as possible to the economic purpose of the invalid provision.
The parties acknowledge that the applicable public law provisions of medical device and product safety law (in particular, MDR/IVDR and national implementing provisions) are mandatory and shall take precedence over conflicting contractual agreements in the event of a conflict.

§ 13 Authoritative Version

These GTC Europe may be made available in different language versions. In the event of contradictions or differences in interpretation, the German version shall be exclusively authoritative.

Last Updated: 01.12.25