COMPLIANCE IN EUROPEAN SOFTWARE DEVELOPMENT

COMPLIANCE IN EUROPEAN SOFTWARE DEVELOPMENT

Does the software meet the requirements that apply in each European market, and is the supplier itself safe to place inside a regulated supply chain? Modsen answers both – requirements translated into architecture, and a delivery setup prepared for a vendor audit.

Two layers of compliance

Regulation reaches a software project from two directions at once, and they are handled differently. We account for both product‑level requirements and supplier‑side compliance when setting up the engineering process.

Inside your product

Requirements become data fields, workflows, permissions, logs and reports. The evidence a supervisor or auditor may ask for can be generated by the system rather than assembled manually after the fact.

Modsen Modsen translates applicable regulatory requirements into technical requirements and builds them into the product architecture and workflows.

Inside Modsen delivery

A data processing agreement, sub‑processor list, access model and security documentation are prepared as part of onboarding. Under NIS2 and DORA, supply‑chain and ICT third‑party risks can become part of your compliance obligations.

Modsen Modsen accounts for these requirements in the delivery setup and prepares the documentation needed for relevant supplier assessments.

Rules that affect European projects

Industry regulation sits on top of a horizontal layer that may apply depending on the product, data and markets involved.

GDPR (and UK GDPR)

  • What we build or account for in the software

    Lawful basis for each processing activity, retention and deletion rules, subject‑rights requests built as product functions, transfer documentation

  • Applies

    Since May 25, 2018

NIS2

  • What we build or account for in the software

    Logging, incident handling inside national deadlines, access control, security requirements passed down to your own suppliers

  • Applies

    National laws following the Oct 17, 2024 transposition deadline; scope and dates differ per country

European Accessibility Act

  • What we build or account for in the software

    Keyboard navigation, screen‑reader support, accessible form errors and authentication, aligned with EN 301 549

  • Applies

    Since Jun 28, 2025

EU Data Act

  • What we build or account for in the software

    Access to data generated by connected products, switching and exit provisions in cloud arrangements

  • Applies

    Since Sep 12, 2025

EU AI Act

  • What we build or account for in the software

    Risk classification, applicable transparency and disclosure requirements, human oversight, documentation and logging controls depending on the AI system and its risk category

  • Applies

    General rules from Aug 2, 2026; Annex III from Dec 2, 2027; Annex I from Aug 2, 2028

Cyber Resilience Act

  • What we build or account for in the software

    Secure‑by‑design requirements, vulnerability handling process, software bill of materials for products with digital elements

  • Applies

    Reporting duties from 11 Sep 2026; full application from 11 Dec 2027

Europe is not one jurisdiction

A product sold in four European countries can sit under different supervisors, and the architecture has to allow for that. Modsen designs shared cores with jurisdiction‑specific rules isolated in configuration, workflows and integrations, so country‑specific requirements can be handled without rebuilding the whole platform.

EU and EEA

EU regulations such as the GDPR apply directly across EU Member States, while directives such as NIS2 are implemented through national law.

EEA countries apply relevant EU legislation after its incorporation into the EEA Agreement

EU hosting and data residency can be handled through configuration

United Kingdom

The UK runs its own rulebook alongside the EU one, with its own regulators and reporting routes.

UK GDPR and UK regulatory requirements, overseen by regulators such as the ICO, FCA and PRA

UK‑specific customs, VAT and import/export requirements for cross‑border transactions

Trusted expertise across different European regions

Oracle
Microsoft
AWS Partner
Google Cloud
OpenAI
Azure Developer Associate
Atlassian
ISTQB
Coursera Microservices
SAFe certified

Compliance by industry

Each domain adds its own rulebook on top of the horizontal layer. We account for these industry‑specific requirements when designing and engineering the relevant software. What that means in practice is set out on the domain pages.

Fintech

PSD2 strong customer authentication and TPP access

DORA ICT risk management and third‑party arrangements

AMLR‑ready KYC and monitoring MiCA disclosures

MiCA disclosures

FCA requirements for the UK market

E-commerce

Destination VAT, OSS and IOSS

Country e‑invoicing formats

Omnibus price history

GPSR product data

Accessibility under the EAA

DSA duties for marketplace models

Logistics

eFTI and e‑CMR datasets

Smart Tachograph 2 data and cabotage counting

ICS2, NCTS and AES customs integrations

CO2 figures per shipment under ISO 14083

Fintech

PSD2 strong customer authentication and TPP access

DORA ICT risk management and third‑party arrangements

AMLR‑ready KYC and monitoring MiCA disclosures

MiCA disclosures

FCA requirements for the UK market

E-commerce

Destination VAT, OSS and IOSS

Country e‑invoicing formats

Omnibus price history

GPSR product data

Accessibility under the EAA

DSA duties for marketplace models

Logistics

eFTI and e‑CMR datasets

Smart Tachograph 2 data and cabotage counting

ICS2, NCTS and AES customs integrations

CO2 figures per shipment under ISO 14083

Fintech

PSD2 strong customer authentication and TPP access

DORA ICT risk management and third‑party arrangements

AMLR‑ready KYC and monitoring MiCA disclosures

MiCA disclosures

FCA requirements for the UK market

E-commerce

Destination VAT, OSS and IOSS

Country e‑invoicing formats

Omnibus price history

GPSR product data

Accessibility under the EAA

DSA duties for marketplace models

Logistics

eFTI and e‑CMR datasets

Smart Tachograph 2 data and cabotage counting

ICS2, NCTS and AES customs integrations

CO2 figures per shipment under ISO 14083

Modsen compliance audit in practice

Value

100% of regulatory compliance gaps eliminated

45% lower security breach risk

9 months to a certificate of compliance

Fintech app audit: product assessment for European certification complianceFintech app audit: product assessment for European certification compliance

Fintech app audit: product assessment for European certification compliance

IT auditing

Challenge

A north‑eastern European payments and remittance app needed to clear GDPR, KYC, PCI DSS, EFTA, AES and ISO 27001 requirements.

Solution

Four Modsen consultants audited data protection, money‑transfer and user‑security compliance in 3.5 weeks, then delivered a 15+ page remediation plan covering MFA, tokenisation, penetration testing and disaster recovery.

Value

100% of regulatory compliance gaps eliminated

45% lower security breach risk

9 months to a certificate of compliance

Value

100% of security compliance gaps eliminated

€0 in regulatory fines

Certificate of compliance obtained

Fintech app audit: product assessment for European certification complianceFintech app audit: product assessment for European certification compliance

Fintech company audit: security standards compliance

IT auditing

Challenge

An Eastern European crypto trading platform needed its web and mobile apps assessed against ISO/IEC 27001 and 27002, OWASP ASVS, BSS, CCSS, PCI DSS and BSA before certification.

Solution

Five Modsen consultants ran penetration testing ahead of the audit, documented gaps in encryption, access control and account creation over 2.5 weeks, and handed over a prioritised remediation plan.

Value

100% of security compliance gaps eliminated

€0 in regulatory fines

Certificate of compliance obtained

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Senior Business Relationship & Partnership Manager, Europe

Discuss compliance for your product

Tell us which markets you operate in and what you are building. You will get a view of which requirements land in the software and which stay outside it.

Natallia DrachicovaSenior Business Relationship & Partnership Manager, Europe

AI use that follows your security policies

AI doesn't have to be used the same way on every project. We adapt its role in the engineering workflow to your European regulatory environment, security policies, data restrictions, and internal AI governance.

No‑AI delivery

For projects where client policies, sensitive data, or security requirements restrict the use of LLM tools, development can run without AI in the engineering workflow.

Restricted environments

Sensitive IP

Client‑mandated AI restrictions

Controlled AI use

AI supports selected engineering tasks within agreed boundaries, while code, architecture, security decisions, and production changes remain under senior engineer review.

Enterprise software

Regulated products

Established security policies

AI‑augmented delivery

AI is used more broadly across approved development and QA workflows to accelerate routine work, with human review and the same security and quality gates applied before release.

Faster release cycles

Routine development at scale

Expanded QA coverage

How Modsen works as your supplier

A vendor questionnaire is faster to answer when the answers already exist.

Contractual documents prepared

We prepare the documentation required for an engagement, including DPAs, Technical and Organisational Measures (TOMs), NDAs, and a disclosed sub‑processor list covering cloud providers and tooling.

Least‑privilege access

Modsen assigns named engineers, provides logged access to client systems, and follows a defined procedure for returning or deleting data at the end of an engagement.

Security policies and reviews

Modsen applies internal security policies informed by ISO/IEC 27001 and OWASP guidance. Project‑specific security reviews and penetration testing are performed where required.

EU‑hosted environments

Our company can place hosting, development, and test environments inside the EU when data residency forms part of the client's obligations.

Ready for your supplier assessments

We supply the documentation needed for DORA ICT third‑party assessments and NIS2 supplier reviews.

Defined AI boundaries

Our AI‑augmented delivery model keeps your source code, personal data and payment data outside external LLM workflows.

What Modsen does, and what stays with you

Modsen delivers

 Architecture and code that carry the requirements Integrations with supervisory and customs systems Registers and logs Reporting exports Technical evidence behind them

You and your advisers keep

 Licences (PI, EMI, CASP and equivalents) Legal and regulatory classification of your AI use cases DPO decisions Customs brokerage Everything actually filed with a supervisor

How compliance enters the work

Rules discovered after launch are expensive because fixing them means touching the core. Modsen front‑loads that discovery.

Applicability map

We map the requirements that apply to the specific product and target countries: which acts apply, where they apply, and which requirements need to be reflected in the software. The resulting document gives your legal advisers a concrete basis for review.

Architecture

A shared core is designed with country‑specific rules isolated in configuration, workflows, and integrations. Entering another market then means adding the relevant rule set and adapters rather than rebuilding the core.

Evidence collected as we build

Logs, registers, test results and technical documentation accumulate during development, so an audit or certification review runs on prepared artefacts.

Change tracked against dates

Relevant regulatory deadlines are added to the delivery backlog with implementation tasks and owners. This puts required changes into the same planning process as other engineering work.

Compliance in European software development: FAQ

Is Modsen a compliance consultancy?

No. Modsen is an engineering partner. We turn regulatory requirements into architecture, workflows and evidence, and work alongside the legal advisers who interpret the rules for your business.

Does one platform work across the EU and the UK?

A shared core can support multiple jurisdictions when jurisdiction‑specific requirements are isolated in configurable rules, integrations and workflows. The applicable legal requirements still need to be assessed for each market.

Will you sign a DPA and appear in our supplier register?

Yes. A data processing agreement, TOMs documentation and a sub‑processor list are prepared as standard, along with the evidence a NIS2 supplier review or DORA third‑party register entry requires.

Can compliance be added to an existing product?

Usually, though cost depends on how deeply the requirement reaches. Data model, access control and logging changes are the expensive ones, which is why we map them before quoting the work.
Background-message

Build software for European regulatory requirements