General Terms and Conditions of E. HAHNENKRATT GmbH Status: 2022-02

1. validity of the conditions

1.1 E. HAHNENKRATT GmbH, Benzstr. 19, 75203 Königsbach-Stein (hereinafter referred to as “HAHNENKRATT”) concludes contracts with and provides services to other companies, legal entities under public law or special funds under public law (hereinafter referred to as “Customer”) exclusively subject to these GTC in the casing valid at the time of the order.

1.2 MDR (EU) 2017/745: Companies that conclude sales contracts with us and are located in the EU must comply with the obligations and requirements of MDR (EU) 2017/745 from 26.05.2021; among other things, with regard to post-market surveillance (including MDR Art. 14 + 25).

1.3 Conflicting or supplementary terms and conditions of the Customer shall not become part of the contract – except with the prior written consent of HAHNENKRATT – even if HAHNENKRATT should perform a contract or render a service without expressly objecting to such terms and conditions. These GTC shall also apply to future transactions, even if HAHNENKRATT does not refer to them in individual cases.

1.4 Contractual guarantees and assurances, in particular if they go beyond the scope of these GTC, require express written confirmation by HAHNENKRATT.

2. offers, prices

2.1 Offers made by HAHNENKRATT are subject to change and non-binding unless they are expressly designated as binding offers. HAHNENKRATT’s order confirmation shall be decisive for the order, whereby the Customer must object immediately in the event of any objections, otherwise the contract shall be concluded in accordance with the order confirmation.

2.2 The prices stated in the order confirmation or, if no order confirmation is given, the prices stated in the respectively valid price list shall be decisive. All prices are subject to the applicable statutory value added tax, unless the turnover would be exempt from value added tax. The prices are ex works and do not include packaging, freight, postage, insurance, customs duties and other expenses.

3. deliveries

3.1 Shipment and transportation of the goods shall be at the Customer’s expense and risk. HAHNENKRATT shall be free to choose the means of transport, whereby the Customer may either arrange the transport with HAHNENKRATT in advance or organize it itself. HAHNENKRATT and the carrier must be notified of any transport damage as soon as the damage becomes apparent.

3.2 Delivery dates shall apply ex works. The delivery dates stated shall only be fixed dates if confirmed in writing by HAHNENKRATT.

Delays in delivery which occur through no fault of HAHNENKRATT shall entitle HAHNENKRATT to extend the delivery period by a reasonable time or to rescind the delivery obligation in whole or in part.

4. payment

4.1 The terms of payment and payment periods specified on the invoice shall apply. If the term of payment is exceeded, HAHNENKRATT shall be entitled to charge interest on arrears in the amount specified in § 288 BGB.

In the case of payment by check, payment shall not be deemed to have been made until HAHNENRKATT’s account has been irrevocably credited.

4.2 The Customer may only set off claims which are undisputed by HAHNENKRATT or have been recognized by declaratory judgment. The Customer shall only be entitled to a right of retention or the defense of non-performance of the contract within the respective contractual relationship.

5. reservation of title

The delivered goods shall remain the property of HAHNENKRATT until the purchase price has been paid in full. The Customer shall notify HAHNENKRATT immediately of any seizure by third parties, in particular in the event of attachment or confiscation. The third party shall be informed immediately of the retention of title.

6 Warranty and liability

6.1 For goods manufactured according to drawings, samples or other information provided by the customer, the customer shall assume liability in the event of infringement of third-party property rights.

6.2 In accordance with the obligation to give notice of defects under Section 377 of the German Commercial Code (HGB), the Customer shall inspect the goods immediately upon receipt and notify HAHNENKRATT in writing of any recognizable defects without delay.

Hidden defects must be reported to HAHNENKRATT in writing immediately after their discovery. Otherwise they shall be deemed accepted.

6.3 In the event of material defects, HAHNENKRATT may, at its option, first provide the Customer with a new, defect-free delivery or remedy the defect by repair before the Customer may assert further rights pursuant to Sections 434 et seq. of the German Civil Code (BGB). HAHNENKRATT shall only accept used goods in sterilized condition due to the risk of infection. If the unsuccessful expiry of a deadline or grace period set by the Customer is to result in the termination of the contractual relationship or a reduction in remuneration, the Customer must notify HAHNENKRATT of this with the deadline set. The deadline must be set in such a way that it allows HAHNENKRATT at least two attempts at rectification. The deadline must be set in such a way that it allows HAHNENKRATT at least two attempts at rectification.

6.4 The warranty period is 12 months from delivery, unless there is a case within the meaning of Clause 6.6. In this case, the statutory limitation period shall apply.

6.5 HAHNENKRATT shall be liable without limitation in the event of intent or gross negligence, for fraudulently concealed defects, for injury to life, limb or health, in accordance with the provisions of the German Product Liability Act, and to the extent of a guarantee assumed by HAHNENKRATT.

6.6 In the event of a breach of an obligation which is essential for achieving the purpose of the contract, HAHNENKRATT shall be liable in the event of slight negligence to the extent that the damage is foreseeable and typical for the type of transaction in question, with liability being limited to a maximum of EUR 10,000.00 for each individual case of damage.

6.7 HAHNENKRATT shall have no further liability – irrespective of the legal grounds.

6.8 The above limitation of liability shall also apply to the personal liability of HAHNENKRATT’s employees, vicarious agents, representatives and bodies.

Download available in all EU-languages: www.hahnenkratt.com

7. traceability via batch number

7.1 HAHNENKRATT maintains a certified quality management system in accordance with EN ISO 13485. In order to ensure traceability for a recall of medical devices in accordance with MDR (EU) 2017:745, the customer must comply with the requirements of MDR (EU) 2017:745 and, among other things, manage and maintain the batch numbers (LOT) to ensure traceability.

7.2 Batch traceability – for our root posts:
EN ISO 13485 (2021-12)
7.5.9.2 Specific requirements for implantable medical devices
The records required for traceability shall include records of components, materials and conditions of the working environment used if these could cause the medical device to fail to meet its specified safety and performance requirements.
The organization shall require that suppliers of distribution services or distributors maintain records of the supply of medical devices that enable traceability and that these records are available for inspection.

Records must be maintained of the name and address of the intended recipient of the shipping packaging, see 4.2.5:

EN ISO 13485 (2021-12)

4.2.5 Control of records
Records shall be maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.
The organization shall establish a documented procedure to determine the control measures required for the identification, storage, protection and integrity, retrievability, retention period of records and disposition of records.

In accordance with applicable regulatory requirements, the organization must establish and implement methods for protecting confidential health information contained in records.
Records must remain legible, easily identifiable and retrievable. Changes made to the records must remain identifiable. The organization must retain the records for at least the lifetime of the medical device as determined by the organization or as specified by applicable regulatory requirements, but for no less than 2 years from the date of release of the medical device by the organization.

8. final provisions

8.1 The law of the Federal Republic of Germany shall apply to the exclusion of the UN Convention on Contracts for the International Sale of Goods and the international conflict of laws.

8.2 HAHNENKRATT’s registered office shall be the place of performance and exclusive place of jurisdiction. HAHNENKRATT may, however, at its own discretion also bring an action at the Customer’s general place of jurisdiction.

8.3 These Terms and Conditions shall remain binding in their remaining parts even if individual points are legally invalid.

8.4 Insofar as these GTC are used in a language other than German, this is only a translation of the German version, whereby the German version shall take precedence, also with regard to the interpretation and interpretation of the formulations used. The German version is available at www.hahnenkratt.com or on request.