General Terms and Conditions (GTC)
of
Europe IT Consulting GmbH
Status: 18 June 2026
Version: 1.0
1. Scope of Application
These General Terms and Conditions apply to all offers, deliveries, services and other business relationships between Europe IT Consulting GmbH, Steinentorstrasse 35, CH-4051 Basel, Switzerland, hereinafter referred to as “Europe IT Consulting” or “Contractor”, and its customers, hereinafter referred to as “Customer” or “Client”.
The services provided by Europe IT Consulting include, in particular but not exclusively, software development, customer-specific software adaptations, add-ons, interfaces, integrations, IT consulting, regulatory consulting, UDI-related support services, support, training, workshops, webinars, test management, validation support, documentation services, as well as the provision and use of software licences, templates, portals and SaaS services such as the Global Submission Portal.
These GTC apply to business customers, companies, legal entities, authorities and other professional clients. Where services are provided to consumers, mandatory consumer protection provisions shall take precedence.
Deviating, conflicting or supplementary terms and conditions of the Customer, in particular purchasing, contractual or payment terms, shall not become part of the contract unless Europe IT Consulting expressly agrees to their applicability in writing.
2. Priority of Individual Agreements
Individual agreements shall take precedence over these GTC.
In the event of contradictions, the following order of precedence shall apply:
- Individually signed contract or written individual agreement
- Written order confirmation by Europe IT Consulting
- Specific offer from Europe IT Consulting, including service description, prices, payment terms, durations and special provisions
- Separately agreed annexes, in particular SLA, data protection agreement, security addendum or IP annex
- These General Terms and Conditions
The respective offer or a subsequently concluded contract shall regulate, in particular, the specific scope of services, prices, quantities, durations, usage packages, payment plans, termination periods, project dates, usage rights and other project- or customer-specific conditions.
3. Offer and Conclusion of Contract
Unless otherwise stated in the offer, offers from Europe IT Consulting shall be valid for 60 calendar days from the date of the offer.
A contract shall be concluded by written acceptance of the offer, by an order from the Customer, by commissioning via email, by signing a contract, by written order confirmation or by the commencement of service provision on the basis of the offer.
Europe IT Consulting is entitled to reject an order if essential technical, economic, regulatory or organisational requirements for the provision of the service are not met.
4. Subject Matter of the Contract and Scope of Services
The type, scope, content and details of the services to be provided shall be determined by the respective offer, specification of services, order confirmation or separately concluded contract.
Services that are not expressly described therein shall not form part of the agreed scope of services.
Additional requirements, extensions, adaptations, new interfaces, new authorities, additional data fields, changed regulatory requirements, new validation rules, adaptations to third-party or customer systems, as well as subsequent change requests shall be considered additional services unless they are expressly included in the agreed scope of services.
Additional services shall be offered separately or charged on a time and material basis according to the agreed hourly or daily rates.
5. Customer’s Cooperation Obligations
The Customer shall provide all information, data, documents, access rights, authorisations, contact persons, technical decisions and approvals required for the provision of the services in a timely, complete and suitable quality.
This applies in particular to product data, UDI data, master data, certificate information, label data, regulatory information, classifications, market information, authority access credentials, mandate information, SRN, CHRN, D.U.N.S., ARTG, certificate, API, M2M or other technical access data.
The Customer is obliged to implement appropriate security measures, in particular data backups, compatibility checks, internal tests, access authorisations and approval processes, insofar as this is required for the respective service.
Delays, additional efforts or errors caused by incomplete, delayed or incorrect cooperation by the Customer may lead to adjustments to the schedule, scope of services and remuneration.
6. Responsibility for Data and Regulatory Content
Europe IT Consulting supports the Customer in the technical, organisational and data-related implementation of the offered services.
Europe IT Consulting is responsible for the professional technical implementation of the services agreed in the offer, in particular for agreed data formats, technical validations, interface logic, portal processes and electronic transmission functions, provided that these are expressly part of the offer or contract.
The professional, regulatory and content-related responsibility for the data, information and approvals provided by the Customer remains with the Customer. This applies in particular to product data, UDI data, master data, certificate information, label data, classifications, market information, product information, authority registrations and other regulatory-relevant information.
Technical validations, plausibility checks, system checks or portal checks by Europe IT Consulting do not replace the regulatory review, verification and approval by the Customer.
Successful technical data transmission does not automatically mean that an authority accepts the data professionally, regulatorily or in terms of content. Feedback, warnings, rejections, validation errors or additional requests from authorities may cause additional effort.
Europe IT Consulting assumes no responsibility for authority decisions, processing times, availability, feedback, rejections, registration deadlines or regulatory assessments by authorities or third parties.
If the Customer receives feedback, warnings, rejections or error messages from authorities or authority portals, the Customer shall inform Europe IT Consulting promptly and provide the relevant feedback in full.
The parties shall jointly analyse whether the cause lies in Customer data, regulatory content, authority requirements, external systems or a technical function of Europe IT Consulting.
If the error is demonstrably based on a technical malfunction attributable to Europe IT Consulting within the agreed scope of services, remediation shall be carried out without additional remuneration. If the error is based on Customer data, changed authority requirements, external systems, missing access credentials or additional requirements not agreed upon, the additional effort may be charged according to the agreed hourly or daily rates.
7. Software Development, Adaptations and Integrations
For software development, customer-specific adaptations, add-ons, interfaces, integrations and comparable technical services, the owed scope of services shall be determined exclusively by the respective offer, specification of services or contract.
Unless expressly agreed otherwise, Europe IT Consulting owes the professional provision of services, but not a specific economic, regulatory or authority-related result.
Changes to Customer systems, third-party systems, authority portals, interfaces, APIs, data models, XSDs, validation rules, regulatory requirements or other external specifications that arise after submission of the offer or during the project term may cause additional effort and may be charged separately.
The Customer is obliged to properly check provided software, adaptations, interfaces or work results and to notify Europe IT Consulting immediately in writing of any defects or deviations.
8. Consulting, Training, Workshops and Webinars
Consulting, training and workshop services shall be provided on the basis of the content specified in the respective offer, order confirmation or event description.
For consulting, training and workshop services, Europe IT Consulting owes professional performance based on the current state of knowledge and the information provided by the Customer. A specific economic, regulatory, technical or authority-related result shall only be owed if this has been expressly agreed in writing.
For regulatory topics, particularly in connection with UDI, EUDAMED, swissdamed, GUDID, AusUDID, MDR, IVDR or comparable requirements, the final assessment, decision, implementation and regulatory responsibility shall remain with the Customer.
Webinar materials, presentations, recordings, templates, examples and other materials provided may only be used for the Customer’s own internal purposes. Disclosure, publication, reproduction, editing or commercial use is not permitted without the prior written consent of Europe IT Consulting.
Webinars, training sessions or workshops shall only be recorded if this has been announced or agreed in advance. Participants may not record or publish events without the prior consent of Europe IT Consulting.
Participation in webinars, online training sessions and online workshops requires suitable technical equipment, up-to-date software and a stable internet connection on the part of the participant. Europe IT Consulting assumes no responsibility for technical disruptions on the participant’s side, in the participant’s IT environment or in the participant’s internet connection.
Europe IT Consulting is entitled to postpone dates for webinars, training sessions or workshops for good cause, in particular in the event of illness, technical disruptions, insufficient number of participants or other circumstances that significantly impede proper execution. In such case, participation fees already paid shall apply to the replacement date, unless otherwise agreed.
9. Portal, SaaS, Licence and Usage Services
Where Europe IT Consulting provides the Customer with software, portals, SaaS services, licences, templates, usage packages or digital platforms, the scope, duration, usage capacities, modules, authorities, submission credits, storage or data volumes and other usage conditions shall be determined by the respective offer or contract.
The Customer shall receive only those usage rights that are expressly granted in the offer or contract. Any further use, disclosure, sublicensing, publication, rental, sale or commercial exploitation is not permitted without the prior written consent of Europe IT Consulting.
Europe IT Consulting is entitled to regularly maintain, update, adapt for security purposes and further develop portals, SaaS services and technical systems. Temporary restrictions due to maintenance, updates, security measures or technical adaptations shall not constitute a defect, provided they are reasonable.
Unless an explicit SLA provision has been agreed, Europe IT Consulting owes reasonable provision of the agreed services in accordance with the state of the art, but no specific minimum availability.
Specific availability levels, support times, response times, maintenance windows, backup provisions, recovery times and service levels shall be determined exclusively by the respective offer, contract or separately agreed SLA annex.
Europe IT Consulting shall not be liable for delays, errors or unavailability caused by authority portals, external interfaces, third-party systems, Customer systems, internet connections, certificates, access data, APIs, M2M access credentials or other systems outside its own sphere of influence.
In the event of material disruptions, Europe IT Consulting shall endeavour, within what is economically and technically reasonable, to analyse the issue, remedy the error or provide suitable workarounds. A claim to specific workarounds, manual substitute processes or free-of-charge adaptations shall exist only if expressly agreed.
10. Data Backup, Backup and Data Availability
Where Europe IT Consulting processes or stores Customer data as part of portal, SaaS or hosting services, Europe IT Consulting shall implement appropriate technical and organisational measures to secure the operated systems and data sets.
Specific backup intervals, retention periods, recovery times, recovery points, geographic redundancy or other disaster recovery provisions shall only be owed if they have been expressly agreed in the offer, contract, SLA annex or security annex.
The Customer remains obliged to maintain its own data backups, export processes, internal controls and approval processes insofar as this is required for its business, quality management, regulatory or legal requirements.
Europe IT Consulting shall not be liable for data losses caused by incorrect Customer data, insufficient Customer-side backup measures, interventions by the Customer or third parties, external systems, authority portals or circumstances not attributable to Europe IT Consulting.
11. Prices, Taxes and External Costs
Unless otherwise stated, all prices are net prices plus legally owed VAT or other applicable taxes and duties.
For cross-border services, the reverse charge procedure may apply depending on the Customer’s registered office and the applicable tax treatment.
External costs, in particular authority fees, certificate costs, third-party provider fees, travel and accommodation expenses, hosting, licence, interface, communication, shipping or other third-party costs, are only included if they are expressly listed in the offer.
External costs not expressly included may be charged separately after prior coordination.
12. Payment Terms and Payment Period
Unless otherwise agreed in the offer or contract, invoices shall be due for payment net without deduction within 30 calendar days from the invoice date.
Payment shall be deemed received when the full invoice amount has been credited to the bank account specified by Europe IT Consulting.
Bank charges, transfer fees, currency exchange fees or other payment fees shall be borne by the Customer insofar as they are caused by the Customer’s payment or the Customer’s bank.
Special payment arrangements, for example advance payments, instalments, annual billing, usage-based billing, billing on a time and material basis, submission credits, usage packages or project-related payment plans, shall be determined by the respective offer or contract.
Unless otherwise regulated in the offer or contract, annual usage packages, portal fees, SaaS fees, support contracts, maintenance contracts, licence fees and subscription services shall be invoiced annually in advance.
13. Default of Payment
After expiry of the agreed payment period, the Customer shall be in default of payment.
In the event of default of payment, Europe IT Consulting is entitled to claim default interest of 5% p.a. as well as reasonable reminder, collection and legal enforcement costs, insofar as legally permissible.
Europe IT Consulting is also entitled to suspend further services until all due outstanding claims have been paid in full. Agreed dates, deadlines or delivery dates shall be extended accordingly by the period of suspension and any resulting delays.
The assertion of further rights remains reserved.
14. Dates, Deadlines and Project Durations
Specified dates, project durations or delivery deadlines shall only be binding if they have been expressly designated as binding in the offer, order confirmation or contract.
Dates are subject to the Customer fulfilling its cooperation obligations in a timely manner and providing required data, approvals, access credentials and decisions on time.
Europe IT Consulting shall not be liable for delays caused by the Customer, authority portals, external interfaces, third-party providers, technical systems outside its own sphere of influence or other circumstances not attributable to Europe IT Consulting.
15. Acceptance and Notification of Defects
Where acceptance is provided for, the Customer shall inspect the provided service within the period agreed in the offer or contract.
If no period has been agreed, an inspection period of 14 working days from provision shall apply.
If no material defects are reported in writing within this period, the service shall be deemed accepted.
Immaterial deviations or open points that do not materially impair the use of the service shall not entitle the Customer to refuse acceptance.
In the event of justified defects, Europe IT Consulting shall initially be entitled to remedy the defect. The Customer shall grant Europe IT Consulting the reasonable time and cooperation required for this purpose.
16. Warranty
Europe IT Consulting shall provide the services with reasonable professional care on the basis of the information provided by the Customer and the requirements described in the offer or contract.
A warranty for specific economic, regulatory, technical or authority-related results shall only be assumed if this has been expressly agreed in writing.
Unless otherwise agreed, the warranty period for individually created software, adaptations or integrations shall be 12 months from acceptance.
For portal, SaaS, licence, support, maintenance or subscription services, the provisions agreed in the offer, contract or separate service or SLA annex shall apply.
Excluded from warranty are defects caused by improper use, changes by the Customer or third parties, incorrect Customer data, faulty Customer systems, external systems, third-party providers, authority portals or non-approved technical environments.
17. Usage Rights, Software, Templates and Know-how
All rights to pre-existing software, standard components, templates, presentations, training materials, webinar materials, methods, concepts, interfaces, frameworks, platform components, documentation, validation logic, tools and know-how shall remain with Europe IT Consulting.
Unless otherwise agreed in the offer or contract, the Customer shall receive a simple, non-exclusive, non-transferable right to use the work results provided to it for the contractually agreed purpose.
Unless otherwise agreed in the offer or contract, the usage right shall be limited to the Customer’s own internal business purposes.
Source code, internal tools, platform components, reusable standard modules, technical frameworks, development documentation or system architectures shall only be transferred or disclosed if this has been expressly agreed in the offer or contract.
Reproduction, disclosure, publication, editing, sublicensing, rental, sale, white-label use, commercial further exploitation, benchmarking for competitive purposes, reverse engineering or use for competing offerings is not permitted without the prior written consent of Europe IT Consulting, insofar as legally permissible.
The specific user group, client group, authority scope, territorial scope, technical scope or other usage restrictions shall be determined by the respective offer or contract.
18. Confidentiality
Both parties undertake to treat all confidential information, trade secrets, technical information, Customer data, project data, access data, price and contractual information, as well as any other information recognisable as confidential, confidentially and to use it exclusively for the performance of the contract.
This obligation shall continue to apply after termination of the contractual relationship.
The confidentiality obligation shall not apply to information that is publicly known, became known without breach of a confidentiality obligation, was independently developed or must be disclosed due to legal, regulatory or judicial obligations.
19. Data Protection, Data Processing and Subprocessors
Europe IT Consulting shall comply with the applicable statutory data protection provisions, in particular Swiss data protection law and, where applicable, the General Data Protection Regulation of the European Union.
The Customer remains responsible for the lawfulness of the data provided and its processing within the Customer’s own area of responsibility.
Where Europe IT Consulting processes personal data on behalf of the Customer, the parties shall, where required, conclude a separate commissioned processing or data processing agreement.
Where commissioned processing or data processing exists, details regarding the subject matter, duration, nature and purpose of the processing, categories of personal data, categories of data subjects, technical and organisational measures, subprocessors, deletion, return and control rights shall be regulated in a separate data protection agreement.
Europe IT Consulting may use suitable subcontractors, service providers and subprocessors insofar as this is necessary for the provision of services. Europe IT Consulting shall ensure that subprocessors used are subject to appropriate data protection and confidentiality obligations.
Europe IT Consulting shall implement appropriate technical and organisational measures to protect personal data and confidential information insofar as this is required within the scope of the agreed services.
20. Security Evidence and Audit Rights
Europe IT Consulting shall implement appropriate technical and organisational measures to protect the systems and portals it operates and the data it processes.
Where the Customer requires evidence of security, data protection or compliance measures for regulatory, data protection or quality-related reasons, Europe IT Consulting shall provide suitable information or evidence upon reasonable request, provided that this does not impair confidential information of other customers, trade secrets, security interests or rights of third parties.
Further audit, inspection or review rights shall exist only insofar as they have been expressly agreed in the offer, contract, data protection agreement or separate security or compliance annex.
Audits must be announced in writing with reasonable notice, carried out during normal business hours and limited to the necessary scope. Europe IT Consulting may require auditors to be subject to appropriate confidentiality obligations.
Costs and effort for customer-specific audits may be charged on a time and material basis unless otherwise agreed.
21. Liability
Europe IT Consulting shall be liable for damages caused by intent or gross negligence in accordance with statutory provisions.
In the event of slight negligence, Europe IT Consulting shall, insofar as legally permissible, only be liable for the breach of essential contractual obligations. In such case, liability shall be limited to the typically foreseeable damage.
Liability for indirect damages, consequential damages, loss of profit, business interruption, data loss, reputational damage, authority delays, regulatory decisions or failure to achieve economic objectives is excluded insofar as legally permissible.
Liability shall, insofar as legally permissible, be limited in total to the order value of the respective offer or contract. For recurring services, liability shall, insofar as legally permissible, be limited to the fees paid within the last twelve months prior to the event giving rise to the damage.
These limitations shall not apply in cases of intent, gross negligence or mandatory statutory liability.
The Customer is responsible for appropriate data backups, internal controls, approval processes and risk mitigation measures.
22. Term and Termination of Continuing Obligations
Durations and termination periods for recurring services, in particular portal, SaaS, licence, maintenance, support or subscription services, shall be determined by the respective offer or contract.
Unless otherwise regulated in the offer or contract, recurring services shall run for one contractual year and shall be extended by a further contractual year in each case unless terminated in writing with a notice period of three months to the end of the respective contractual term.
Services already rendered, incurred expenses, external costs and contractually agreed minimum terms shall remain payable.
The right to extraordinary termination for good cause remains unaffected.
23. Data Return and Data Deletion after Contract Termination
After termination of portal, SaaS or data-related services, Europe IT Consulting shall, upon request, provide the Customer with the Customer data stored in the portal or system in a reasonable, machine-readable format, insofar as this is technically possible and contractually owed.
Data shall be provided within a reasonable period after the end of the contract. Scope, format, deadline, costs and any temporary read-only access after the end of the contract may be further specified in the offer, contract or a separate exit provision.
After expiry of statutory, contractual or technically required retention periods, Europe IT Consulting shall be entitled to delete Customer data, provided that no statutory retention obligations, legitimate interests or outstanding payment or dispute issues prevent this.
Backups may continue to exist for a reasonable period for technical reasons, but shall not be used productively and shall be deleted or overwritten after expiry of the regular backup cycles.
24. Force Majeure and External Circumstances
Europe IT Consulting shall not be liable for delays or obstacles to performance that lie outside its reasonable sphere of influence.
This includes, in particular, natural events, illness, labour disputes, official measures, outages of energy supply, internet, hosting services, telecommunications, authority portals, third-party systems, certificates, APIs, M2M access credentials, Customer systems or other external technical systems.
The party affected shall inform the other party appropriately about the obstacle to performance and its expected duration.
25. Reference Naming
Europe IT Consulting may publicly name the Customer as a reference or use the Customer’s logos only if the Customer has expressly consented to this in advance.
Internal project experience and anonymised information may be used to improve Europe IT Consulting’s own services, methods and processes, provided that no confidential information or personal data is disclosed.
26. Written Form
Amendments, supplements and ancillary agreements require written form or confirmation by email, unless a stricter form has been agreed in the offer or contract.
This also applies to any amendment of this written form requirement.
27. Severability Clause
Should individual provisions of these GTC or of a contract be or become invalid or unenforceable, the validity of the remaining provisions shall remain unaffected.
The parties shall replace the invalid or unenforceable provision with a valid provision that comes as close as possible to the economic purpose of the original provision.
28. Applicable Law and Place of Jurisdiction
Swiss law shall apply, excluding conflict-of-law provisions and excluding the UN Convention on Contracts for the International Sale of Goods, insofar as such exclusion is permissible.
The place of jurisdiction shall be Basel, Switzerland, insofar as legally permissible. Europe IT Consulting shall remain entitled to assert claims also at the Customer’s general place of jurisdiction.
