Importers placing machinery and related products on the EU market under Regulation (EU) 2023/1230 must ensure both substantive compliance and full document traceability from the moment of entry into the Union. The Regulation requires that conformity assessment procedures be completed, the CE marking affixed, and technical documentation made available to competent authorities, with clear digital contact details provided on the label or the product itself. In addition, instructions and information may be supplied in a digital and printable format, while the printed version must still be provided upon the user’s request.
What changes for importers?
For importers and distributors, the Regulation strengthens the entire chain of responsibility. They must verify that the manufacturer has performed the conformity assessment, prepared the technical documentation, and affixed the CE marking. Importers must also include their name, trademark, and digital contact details (website, email) on the product, with limited exceptions for size or packaging constraints. Authorities may request access to documentation at any time; instructions and related information must be precise, up to date, and provided in the language required by the Member State.
Digital Document Management: what’s really needed?
The Regulation explicitly allows and encourages digital documentation: instructions “in digital printable format” and availability of a paper copy on request, with strict requirements for clarity, accessibility, and updating. To ensure compliance, importers should implement a Document Management System (DMS) that guarantees version control, audit trails, user-based access, resilience, and availability — all while complying with GDPR. These functional requirements are further detailed in the operational guidelines for digital documentation under the Machinery Regulation, including backup systems, strong authentication, and logging.
Why Certiblok is a native-compliance ally
Certiblok is a document management platform built on decentralized cloud architecture with AES-256 encryption. Each file is split into 80 fragments distributed across a global network of about 26,000 blockchain-monitored nodes, dramatically reducing the risk of data breaches and ransomware while ensuring operational continuity. Its geo-distributed nature guarantees high availability and full file reconstruction from only 29 fragments, providing importers with a robust repository for technical files, EU declarations, manuals, and update logs.
Key functions for Regulation (EU) 2023/1230
Certiblok’s DRM® (Document Relationship Management) system gives each document a digital identity — including owner, version history, expiration dates, activity logs, QR code, and Audit Room — enabling secure sharing with authorities, notified bodies, and partners without duplicating files or breaking the chain of custody. Edit Rooms allow controlled revisions; active sharing automatically notifies recipients of updates, maintaining document alignment between manufacturers and importers as required by Regulation (EU) 2023/1230.
A “living” QR code for every document
Certiblok generates a unique QR code for each document, configurable as public or protected. In public mode, importers can print the QR on labels or packaging: users scanning it always access the latest version of manuals, EU declarations, and updates—fully consistent with the Regulation’s provision for digital printable instructions. In private mode, the same QR requires authentication and role-based access; the URL can be revoked, and every view feeds into the audit trail (who accessed what and when). If a document is withdrawn or revised, the QR code remains the same but points to the current version, preventing field errors and disputes over outdated copies. The result is a streamlined, traceable, and verifiable documentation flow—from first market entry to post-market surveillance.
Security, traceability, and proof of compliance
The zero-trust architecture and immutable event logging create a complete audit trail: who accessed what, when, and which version. This facilitates cooperation with market surveillance authorities and quick presentation of the technical file. Single Sign-On (Google/Microsoft) and end-to-end encryption uphold the security and privacy principles required for reliable digital documentation.
For importers seeking compliance with Regulation (EU) 2023/1230, the most efficient approach is to centralize technical documentation within a secure DRM system with versioning, traceability, and controlled access. Certiblok integrates all these features with blockchain resilience and collaborative tools designed for audits and inspections—reducing both compliance risks and time from due diligence to market placement.
Learn more at certiblok.com — or contact us for a personalized consultation, demo, or free trial.
Certiblok STORAGE
Archivia i documenti in totale sicurezza con spazi di archiviazione per ogni esigenza in un cloud decentralizzato
Certiblok SHARING
Condividi e richiedi documenti in un click. Definisci permessi e scadenze per ogni documento.
Certiblok EDITING
Modifica online i documenti con i membri del tuo Team.
Certiblok AUDITING
Il controllo completo sulla gestione dei documenti per due diligence, ispezioni o specifici utilizzi.
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CERTIBLOK,
LA PIATTAFORMA DRM®
Document Relationship Management,
che rivoluziona il modo di gestire e condividere i documenti, anche quelli più riservati.
Semplifica il lavoro in team, gestisce le scadenze, ti collega con clienti, fornitori, consulenti ed enti ispettivi, garantendo la massima protezione del tuo patrimonio documentale attraverso il cloud decentralizzato e la tecnologia Blockchain.
Funzioni
Distributore per la Svizzera
Member of
