What must a product manager confirm before launch? 7 requirements explained one by one

For a product heading to the EU, the product manager must settle in the development schedule the EU CRA product category, assessment route, support period and technical documentation, and the EU AI Act provider obligations for high-risk AI. This page goes through the EU CRA, the EU AI Act, ISO/IEC 29147 and 30111, IEC 62443-4-2, ISO/SAE 21434, ISO 42001 and TISAX prototype protection: what to decide first, what to finish before launch, and how long it takes.

Updated 2026-11-03

Direct answer: the product manager has to confirm, inside the development schedule, which laws each product line must meet, which assessment route it takes and which documents must be ready before launch. For products entering the EU, Article 13 of the EU CRA requires manufacturers to complete the technical documentation and conformity assessment before placing the product on the market, then draw up the EU declaration of conformity and affix the CE marking; at launch the product must have no known exploitable vulnerabilities and a secure-by-default configuration; and vulnerabilities must be handled effectively throughout the support period, which is at least five years, or the expected use time if shorter. Where the product contains high-risk AI, Article 16 of the EU AI Act requires the provider to run a quality management system, complete conformity assessment, draw up a declaration of conformity, affix the CE marking and register. Own-brand, ODM and OEM roles carry different obligations, so clarify the role first.

What to confirm before launch (EU CRA)

DecisionKey wordingWhat the product manager does
Product category and assessment routeDefault products can use internal control (module A); important class I products without full use of harmonised standards, class II and critical products need a third-party procedureClassify each product line and put it in the schedule
Support period (Article 13(8))At least five years; where the expected use time is under five years, the expected use timeSet the support period at planning time and fund security updates to match
State at launch (Annex I Part I)No known exploitable vulnerabilities; secure-by-default configurationMake vulnerability scanning and a default-settings review a launch gate
Vulnerability handling (Annex I Part II)An SBOM in a commonly used, machine-readable format; remediation without delay through security updates; a coordinated vulnerability disclosure policyShip the SBOM and the security update mechanism with the product
Pre-launch documents (Article 13(12))Draw up the Article 31 technical documentation and carry out the Article 32 conformity assessment, then draw up the EU declaration of conformity under Article 28 and affix the CE marking under Article 30Make the technical documentation and assessment launch milestones
TimingArticle 14 reporting obligations apply from 11 September 2026; the other main obligations apply in full from 11 December 2027Products launched after 11 December 2027 must meet all requirements

Requirement by requirement: what the product manager decides, what to finish before launch, how long it takes

EU Cyber Resilience Act (CRA)

EU AI Act

ISO/IEC 29147 and 30111 vulnerability disclosure and handling

IEC 62443-4-2 industrial control products

ISO/SAE 21434 automotive products

ISO 42001 AI management system

TISAX prototype protection

How it fits the systems you already have

Product development already has milestones and a launch review; the new requirements belong in those existing gates, not in a separate process.

Existing gateHow the new requirements fold in
Product planning and approvalDetermine the CRA category and assessment route and the AI system risk tier; set the support period
Design reviewRisk assessment against the CRA Annex I essential requirements; TARA for automotive products
Launch reviewNo known exploitable vulnerabilities, secure defaults, SBOM, technical documentation, declaration of conformity and CE marking
Post-launch maintenanceVulnerability handling and security updates, coordinated vulnerability disclosure, CRA Article 14 reporting

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Compliance needs all three; a consultant's value is integration

CRA, TISAX, ISO 27701 and the AI Act are not single technical problems. They are only complete when process, security technology and legal compliance all hold at the same time. Fix only one and the gaps in the other two surface during audits, incident reporting or customer due diligence, and the work has to be redone.

DimensionThe question it answersTypical gap when only this part is done
Process (management system)Who is responsible, what is done, when, where the evidence is, how it improvesTools are in place but nobody runs them on schedule, so there are no records at audit time
Security technologyHow controls are designed and how their effectiveness is verifiedDocuments are complete but the systems do not actually do what they describe
Legal complianceWhich regulation applies, which role you hold, the deadlines and penaltiesControls are built against the wrong regulation or role, so obligations are not covered

Winners' consulting team covers all three dimensions and plans regulatory scoping, process design and technical controls together, so a single body of evidence serves multiple regulations and customer requirements.

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