CE Marking Procedures

Document and manage your CE marking conformity assessment procedures aligned with EU MDR Annex IX-XI. Track conformity assessment routes, notified body interactions, and ensure all prerequisites are met before applying the CE mark to your devices.

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Part of Regulatory Affairs

ISO Templates Post-Registration Review Inspection Readiness Implant Cards Device Master Records Site Security Plans Product Registrations UDI Records GUDID Submissions Declarations of Conformity Essential Requirements Technical Documentation Regulatory Submissions Economic Operators Regulatory Commitments Regulatory Intelligence EUDAMED Reports Notified Body Management

Key Capabilities

What you get with the CE Marking Procedures module.

Conformity assessment route determination based on device classification

Notified body interaction tracking including applications, audits, and certificates

Prerequisite checklist management ensuring all CE marking conditions are satisfied

CE marking procedure documentation with regulatory reference tracking

Certificate expiration and renewal management with proactive alerts

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Watch how MoniDoseQMS handles regulatory affairs workflows end-to-end.

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Platform tour

A guided tour of MoniDoseQMS after you log in — your profile, the everyday tools (notifications, recycle bin, tasks, events, regulatory news), and the dashboard.

How It Connects

CE Marking Proceduresdoesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.

Declarations of Conformity Essential Requirements Notified Body Management

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More in Regulatory Affairs

Explore other modules in the Regulatory Affairs category.

ISO Templates

Access a comprehensive set of ISO-compliant document templates that cover the full scope of your quality management system. Save weeks of preparation with templates structured to meet ISO 13485, ISO 14971, and other critical standards out of the box.

Post-Registration Review

Evaluate changes to registered products to determine if regulatory submissions or notifications are required. Streamline your post-registration review process to ensure changes are assessed against global regulatory requirements before implementation.

Inspection Readiness

Stay prepared for regulatory inspections at all times with a centralized readiness dashboard and structured preparation checklists. Identify gaps before inspectors arrive and ensure your team is confident, organized, and audit-ready.

Implant Cards

Generate and manage implant cards as required by EU MDR Article 18 for implantable medical devices. Ensure patients receive the required identification information including device details, UDI, and essential safety information.

Device Master Records

Compile and maintain Device Master Records (DMR) containing all specifications, procedures, and instructions needed to manufacture your products. Ensure your DMR is complete, current, and readily accessible for production and regulatory purposes.

Site Security Plans

Develop and maintain site security plans that protect your manufacturing facilities, products, and intellectual property. Document access controls, threat assessments, and emergency procedures to ensure physical security compliance for regulated production environments.