Denmark Medical Device Adverse Event Report

Streamline Medical Device Adverse Event Reporting in Denmark

Medical device manufacturers, healthcare facilities, and regulatory professionals in Denmark need a reliable way to report adverse events involving medical devices. This Denmark Medical Device Adverse Event Report template helps you capture all the critical information required by Danish health authorities, including patient CPR numbers, device details, and comprehensive incident descriptions.

Built for Danish Healthcare Compliance

Denmark has strict requirements for reporting medical device incidents to Lægemiddelstyrelsen (Danish Medicines Agency). This form template is designed specifically for the Danish regulatory environment, incorporating fields for CPR numbers (Civil Registration Numbers), CVR numbers for organisations, and all the device-specific information needed for thorough incident documentation.

Whether you're a hospital, clinic, medical device distributor, or manufacturer operating in Denmark, this form ensures you collect structured, complete data that meets regulatory standards and supports patient safety initiatives.

Paperform Makes Regulatory Reporting Easier

With Paperform's intuitive form builder, you can customise this template to match your organisation's specific reporting protocols while maintaining compliance with Danish requirements. The doc-style editor lets you add your branding, adjust conditional logic to show relevant fields based on incident type, and include internal process notes or guidance.

Automate your post-submission workflow with Stepper: Once an adverse event report is submitted, use Stepper to automatically route notifications to your quality team, create tracking records in your compliance management system, generate case numbers, and trigger follow-up tasks. You can even set up different workflows based on incident severity, ensuring critical events receive immediate attention.

Secure document trail with Papersign: If you need signed acknowledgments from reporting staff or follow-up consent from patients, Papersign lets you turn form submissions into eSignature documents, creating a complete audit trail from initial report through investigation and resolution.

Key Features for Healthcare Organisations

This template includes conditional logic to show relevant fields based on whether the report involves a patient incident, device malfunction, or near-miss event. You can collect detailed device identifiers (UDI, serial numbers, model information), capture the sequence of events, assess severity and outcomes, and document immediate corrective actions—all in one streamlined form.

The form works beautifully on any device, so healthcare professionals can submit reports from hospital workstations, tablets at the point of care, or mobile devices. Submissions integrate seamlessly with your existing systems via Paperform's native integrations, webhooks, or Stepper workflows, ensuring adverse event data flows directly into your quality management and regulatory compliance platforms.

Trusted by healthcare organisations across Denmark and beyond, Paperform is SOC 2 Type II and GDPR compliant, providing the security and data protection standards essential for handling sensitive healthcare information.