General Terms and Conditions (GTC) –
Digital Approval Platform 

One important thing upfront: Your satisfaction is very important to us. Should you – for any reason – have cause for complaint about our services, please speak to us. Together we will find a solution! 

1. Application 

1.1 These General Terms and Conditions apply to the use of the Digital Approval Platform ("DAP") of Johner Institut GmbH, Reichenaustraße 39a, 78467 Konstanz ("Johner Institut"). By accepting the terms, the contracting party ("Customer") agrees to the validity of these General Terms and Conditions. These General Terms and Conditions apply irrespective of whether the orderer is an entrepreneur (§ 14 BGB), a consumer (§ 13), or a legal entity under private or public law. 

1.2 Deviating terms and conditions of the Customer do not apply. This also applies if Johner Institut does not explicitly object to their inclusion. 

2. Conclusion of Contract 

2.1 The contract between Johner Institut and the Customer is concluded by the Customer’s acceptance of an offer from Johner Institut. 

2.2 The contract is concluded upon receipt of the Customer's declaration of acceptance by Johner Institut in the original, as a copy, or in electronic form. Contract offers from Johner Institut that are altered by the Customer in terms of content shall be deemed new offers from the Customer; the contract shall then only be concluded by explicit acceptance by Johner Institut; the provision of services shall not be deemed implicit acceptance. 

3. Subject of the Contract, Provision, Customer's Obligations 

3.1 The DAP is intended to facilitate the recording and provision of technical documentation required for conformity assessment procedures for medical devices by properly structuring, formatting, and presenting the data. 

3.2 The subject of the contract is the remunerated and temporally limited provision of the use of the DAP in the Customer's company over the internet. The Customer receives simple, non-sublicensable, and non-transferable rights limited to the term of the contract to use the current version of the DAP for the contractually specified number of users via access through a browser in accordance with the contractual provisions. 

3.3 Access to the DAP is enabled via the communication of access data. 

3.4 The Customer is obligated to keep the access data and passwords confidential and to prevent unauthorized use by third parties. In the case of misuse, Johner Institut is entitled to block access. The Customer is liable for misuse that he is responsible for. 

3.5 The Customer is responsible for meeting the technical requirements for the use of the DAP, especially concerning hardware and operating systems. In the event of further development of the DAP by Johner Institut, it is the Customer's responsibility to independently make the necessary adjustments to the software and hardware he uses. 

3.6 Ensuring the regulatory compliance of a quality management system or technical documentation created with the help of the DAP remains the Customer's sole responsibility at all times. 

3.7 The Customer is responsible for storing the content generated via the DAP. 

4. Scope of Services, Availability 

4.1 Access to the DAP is generally available seven days a week, 24 hours a day, with an availability of 95% calculated over the calendar year. 

4.2 Johner Institut is entitled to change, restrict or replace the accessible functionalities of the DAP and to reasonably modify modules regarding their contents, particularly to reduce or extend them. If such a change results in a significant restriction of a functionality, the Customer is entitled to terminate the contract without notice. The right to terminate may be exercised within a period of six weeks from the occurrence of the significant restriction. 

4.3 Johner Institut makes no warranties for regulatory compliance, for passing audits, or examinations by notified bodies, authorities, or other regulatory bodies of quality management systems or technical documentation. 

5. Remuneration, Price Adjustment, Set-off 

5.1 The remuneration for the use of the DAP is determined by the specific offer. All prices are net prices plus applicable statutory VAT. 

5.2 Unless otherwise agreed, Johner Institut will invoice the Customer monthly for its services. 

5.3 Invoices are payable within fourteen (14) days without deduction, unless otherwise agreed. In case of default of payment by the Customer, Johner Institut is entitled to charge default interest in accordance with § 288 para. 2 BGB at the rate of currently nine percentage points above the respective base interest rate. Johner Institut reserves the right to claim higher default damages. 

5.4 The Customer may only offset claims for remuneration by Johner Institut with legally established or undisputed claims. 

6. Term and Termination 

6.1 Unless otherwise agreed, this contract is subject to a minimum term of one year and a notice period of three months. Terminations can be sent in writing to the above institute address or by email to info@johner-institut.de. If no timely termination is made, the contract is extended by one year. 

6.2 The right to terminate for good cause remains unaffected. Good cause for the orderer includes, in particular, if the Customer is in arrears with payment of the remuneration for a period of more than two months or if he repeatedly and also after warning refuses his obligation to cooperate. 

6.3 Termination by either party does not affect rights and obligations that arose before the legal termination of the agreement. 

7. Liability 

7.1 Johner Institut is liable to the Customer in all cases of contractual and non-contractual liability for intent and gross negligence in accordance with the statutory provisions for damages or reimbursement of futile expenses. 

7.2 In other cases, Johner Institut is only liable, except as provided in para. 3, for the breach of a contractual duty, the fulfillment of which makes the proper execution of the contract possible in the first place and on whose compliance the Customer can regularly rely (so-called cardinal duty), limited to the replacement of the foreseeable and typical damage. In all other cases, the liability of Johner Institut is excluded, subject to the provision in 7.3. 

7.3 The liability for damages arising from injury to life, body or health and under the Product Liability Act remains unaffected by the above limitations and exclusions of liability. 

Johner Institut is not responsible for content (e.g., texts, images, layouts, illustrations) provided or uploaded by the Customer or content resulting from use by third parties, especially Customer's contract partners. 

8. Confidentiality 

Johner Institut and the Customer commit to maintaining confidentiality about business and trade secrets and confidential information of the other party that became known to them. The obligation to maintain confidentiality continues beyond the duration of contracts concluded between the parties. Both parties will ensure that their employees comply with this obligation. 

9. Data Protection 

9.1 The Customer ensures that the data processing systems, processes, and data inventories at his premises comply with the EU General Data Protection Regulation, the Federal Data Protection Act, and the respective State Data Protection Act. This applies especially to the processing (Art. 4 No. 2 GDPR) of data and data inventories. The Customer must also maintain an appropriate data backup system before and during the cooperation. The adequacy of the data backup system is determined by the legal provisions of Art. 32 GDPR. 

9.2 Johner Institut ensures that it will not perform any actions in the course of fulfilling the contract that would violate existing data protection regulations. 

9.3 Johner Institut and the Customer commit to concluding a data processing agreement in accordance with the provisions of Art. 28 GDPR, where legally required for the execution of contracts based on these General Terms and Conditions. Processing on behalf is especially necessary when Johner Institut processes personal data for which the Customer is responsible under Art. 4 No. 7 GDPR, within the scope of contract execution. 

10. Use of Artificial Intelligence (AI) 

10.1 Johner Institut uses artificial intelligence (AI) (models from Azure OpenAI) in certain areas of the Post-Market Manager to enable functionalities such as the analysis of customer-specific databases and generating targeted responses. 

10.2 The AI models are trained on a variety of data and can recognize patterns and respond to provide high-quality services, supporting customers in analyzing self-built databases. 

10.3 Customer data is not used for training the AI models. No personal data is transmitted to the AI models. Even if personal data is stored in the Post-Market Manager, it will not be forwarded to third parties in the course of using the AI models. 

10.4 Despite careful development and implementation, AI models can make errors. Johner Institut assumes no liability for decisions made by customers based on information provided by the AI. It is the responsibility of the Customer to assess the context and reliability of the information provided by the AI. 

10.5 By using the Post-Market Manager, the Customer accepts that Johner Institut uses AI models in the Post-Market Manager and agrees to the associated terms. 

11. Intellectual Property 

11.1 The content provided by Johner Institut may be protected by copyright. All rights constituted thereby, especially the exploitation rights as per §§ 15 to 27 UrhG, are reserved for Johner Institut or the authors and license holders, unless otherwise agreed. 

11.2 The Customer does not receive any ownership or exploitation rights to the provided and non-personalized contents, particularly templates, templates, etc., unless otherwise agreed. 

12. Adjustment of General Terms and Conditions 

12.1 An adjustment of these terms may occur, 

(a) if required by applicable law; 

(b) when expanding Johner Institut's service offering; 

(c) in case of a change of provisions beneficial to the Customer. 

12.2 Johner Institut will inform the Customer about a change in these General Terms and Conditions before they take effect. The information about the change will be communicated in an email message or other suitable form. There exists the possibility to terminate the contracts concluded based on these General Terms and Conditions within 14 days before the change takes effect. This does not affect the possibility of agreeing that the contracts concluded will continue under the conditions of the General Terms and Conditions valid at the time of conclusion. 

13. Final Provisions 

13.1 For legal disputes arising out of or in connection with this contract, only German law is applicable, excluding the provisions of international private law and excluding the UN Sales Convention. 

13.2 For merchants or persons without a permanent residence in Germany, the place of jurisdiction for legal disputes arising from or in connection with this contract is exclusively Konstanz. 

13.3 There are no oral side agreements. Supplementary or divergent agreements require written form to be effective. The requirement of written form can only be waived by written agreement. Individual agreements within the meaning of § 305b BGB, where form requirements are not mandatory, are exempt. 

13.4 Should any provision of this contract be or become invalid, contain an inadmissible time limit, or contain a gap, the validity of the remaining provisions shall remain unaffected. Unless the invalidity results from a violation of §§ 305 ff. BGB, a valid provision that comes closest to what the parties intended economically shall be deemed agreed upon. The same applies in the case of a gap. In the case of an inadmissible time limit, the legally permissible measure applies. 

13.5 The transfer of rights and obligations arising from the contract by a party to third parties requires the prior written consent of the other party. Consent may only be refused for good reason.