Complass – Navigate compliance Complass – Navigate compliance

Who it’s for

Complass for integrators and plant builders

You plan, build, extend or maintain plants for your customers, connecting machinery, controllers and networks from different vendors. Operators expect a security programme under IEC 62443 from you. And as soon as you link machines into a plant or modify them substantially, you can become the manufacturer yourself. Complass shows what applies then and keeps the documents per customer plant.

Zones and conduits of a plant as a plan in Complass (sample project)

The challenge

Every plant is different

Components from many vendors, customer specifications and existing plants: the security concept is created anew for every project.

Suddenly the manufacturer

Anyone who connects machines into an assembly or substantially rebuilds a plant takes on manufacturer duties up to CE marking.

Remote access to many customers

Remote maintenance and remote commissioning are practical, but also a way in. Operators want to see how you secure access.

Your obligations as an integrator

As a service provider you mainly meet your customers’ requirements. As the manufacturer of an assembly of machinery or after a substantial modification, statutory obligations apply to you:

Frameworks: IEC 62443 for integrators and service providers · Machinery Regulation · CRA · IEC 62443 · In preparation: Complete CE file covering all requirements of the Machinery Regulation

  • IEC 62443-2-4 describes requirements for the security programme of service providers for the integration and maintenance of industrial automation systems; operators often make them part of the contract
  • IEC 62443-3-3 describes technical security requirements for the system and security levels; they are the basis for your system design
  • Assemblies of machinery that work together as a unit count as machinery themselves; whoever puts them together is the manufacturer under the Machinery Regulation from 20 January 2027 Art. 3 MRArticle 3 Machinery Regulation DefinitionsFor the purposes of this Regulation, the following definitions apply: (1) ‘machinery’ means: - (a) an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application; - (b) an assembly referred to in point (a), missing only the …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗
  • Anyone who substantially modifies a machine counts as the manufacturer and must assess and declare the conformity of the affected machine again Art. 18 MRArticle 18 Machinery Regulation Other cases in which obligations of manufacturers applyA natural or legal person that carries out a substantial modification of machinery or a related product shall be considered to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 10 for that machinery or related product or, if the substantial modification has an impact on the safety of only machinery or a related product that is part of …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗
  • As the manufacturer: risk assessment, technical documentation, conformity assessment, EU declaration of conformity and CE marking; for partly completed machinery a declaration of incorporation and assembly instructions Art. 10 MRArticle 10 Machinery Regulation Obligations of manufacturers of machinery and related products1. When placing machinery or a related product on the market or putting it into service, manufacturers shall ensure that it has been designed and constructed in accordance with the essential health and safety requirements set out in Annex III. 2. Before placing machinery or a related product on the market or putting it into service, manufacturers shall draw up the technical documentation set out in Annex IV, Part A …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗ Art. 11 MRArticle 11 Machinery Regulation Obligations of manufacturers of partly completed machinery1. When placing partly completed machinery on the market, manufacturers shall ensure that it has been designed and constructed in accordance with the relevant essential health and safety requirements set out in Annex III. 2. Before placing partly completed machinery on the market, manufacturers shall draw up the technical documentation set out in Annex IV, Part B. Where compliance of partly completed machinery with …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗ Art. 21 MRArticle 21 Machinery Regulation EU declaration of conformity of machinery and related products1. The EU declaration of conformity shall state that the fulfilment of the applicable essential health and safety requirements set out in Annex III has been demonstrated. 2. The EU declaration of conformity shall have the model structure set out in Annex V, Part A, and shall contain the elements specified in the relevant modules set out in Annexes VI, VIII, IX, and X. It shall be continuously updated and shall be …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗
  • If you substantially modify a product with digital elements and make it available, you also count as the manufacturer under the CRA, for the modified part or the whole product Art. 22 CRAArticle 22 Cyber Resilience Act Other cases in which obligations of manufacturers apply1. A natural or legal person, other than the manufacturer, the importer or the distributor, that carries out a substantial modification of a product with digital elements and makes that product available on the market, shall be considered to be a manufacturer for the purposes of this Regulation. 2. The person referred to in paragraph 1 of this Article shall be subject to the obligations set out in Articles 13 and 14 …As of: 06.10.2026 · Source: EUR-Lex – OJ L 2024/2847, 20.11.2024, corrigenda incorporated: OJ L 2024/90780, 5.12.2024; OJ L 2025/90555, 2.7.2025; OJ L 2025/90828, 17.10.2025Open original (EUR-Lex – OJ L 2024/2847, 20.11.2024, corrigenda incorporated: OJ L 2024/90780, 5.12.2024; OJ L 2025/90555, 2.7.2025; OJ L 2025/90828, 17.10.2025) ↗

Not sure which frameworks apply to you? Start the applicability check

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When you become the manufacturer. A modification is substantial if the manufacturer did not foresee it and it affects safety because a new hazard arises or an existing risk increases. The risk assessment shows whether this is the case. The page for manufacturers shows what manufacturers then have to meet. Go to the page for manufacturers

General information, not legal advice. This page summarises the legal position in simplified form and does not replace an assessment of your individual case. The wording of the laws and standards is authoritative.

Typical companies

Automation system integrators Focus area

Control, process control and network technology for manufacturing and process industry.

Plant and special-purpose machinery engineering

Lines and assemblies of machinery from different vendors, with CE marking of the assembly.

Retrofit and modernisation

New controllers, networking and remote access for existing plants; this is where the question of substantial modification arises.

Maintenance and service providers

Remote maintenance, updates and troubleshooting according to the operators’ requirements.

How Complass helps

Security programme under IEC 62443-2-4

A framework of its own for integrators: from scope of services and staff to hardening, remote access and patch management up to FAT, SAT and handover to the asset owner.

Zones, conduits and system design

Divide the plant into zones and conduits, set security levels and document remote access as conduits, in a project of its own per customer plant.

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Assess modifications and CE documents

With the Machinery Regulation framework you assess a modification and draw up the risk assessment, technical documentation and declarations with a focus on the cybersecurity of the control system.

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Vulnerabilities of installed components

Find known vulnerabilities of the components you install and provide your customers with recommendations.

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Action plan with owners, deadlines and status in Complass (sample project)
Tasks per customer plant in view

Matching offers

The industry template preselects IEC 62443 and the Machinery Regulation; the Manufacturers template adds the CRA for products you place on the market yourself.

available

Industry template: Industry

  • IEC 62443 for asset owners, integrators and manufacturers
  • Machinery Regulation with the cybersecurity requirements for control systems
  • Asset management for IT and OT
  • MITRE ATT&CK for Enterprise and ICS

from €526 per month plus VAT in the Start package, size S, annual payment

available

Industry template: Manufacturers

  • Cyber Resilience Act per product up to CE marking
  • Radio Equipment Directive with EN 18031
  • Vulnerability management with SBOM

from €427 per month plus VAT in the Start package, size S, annual payment

All prices are for businesses, not for consumers. They are net plus VAT with annual payment; monthly payment carries a surcharge of 15 %. As of 16 October 2026. Enterprise and groups of companies on request.

Frequently asked questions

When is a modification substantial?

If the manufacturer did not foresee it and it affects safety, for example because new protective devices or a changed safety control system become necessary. Under the Machinery Regulation this explicitly also covers digital modifications, such as new software or new networking. The result of the risk assessment is decisive.

What is the difference between IEC 62443-2-4 and 3-3?

IEC 62443-2-4 concerns your organisation as a service provider, that is processes, staff and approach in integration and maintenance. IEC 62443-3-3 concerns the technical system you deliver, with requirements per security level. Complass covers both in one framework for integrators.

Can we keep several customer plants separate?

Yes, each plant as a project of its own with its own zones, tasks and documents. With the partner portal you can also look after your customers’ accounts from one overview.

Try Complass with your own data

Set up your trial yourself, with a sample project per framework if you like. If you would rather see Complass first, request a demo.