New tool to help researchers and clinicians with regulatory requirements

When health technology solutions are to be used in hospitals and patient treatments, extensive requirements for safety, quality, and documentation are imposed. These requirements are necessary to ensure patient safety and obtain regulatory approvals.

In many innovation projects, requirements for documentation and approvals are often addressed late in the development process. This can lead to delays, increased costs, and, in the worst case, a promising solution that never reaches the market, the clinic, and the patients.

Important to act early

An early focus on regulatory aspects provides better conditions for a smooth transition from idea to clinical application. Here, RegMetrics serves as an educational and digital support tool for the very early exploration of the regulatory “pathway”.

The platform helps researchers and clinicians gain an overview and understand the relevant requirements already in the initial phases of development, and supports a more structured approach to documentation and approvals. As a pilot initiative, MedTech Odense is making RegMetrics available for a limited period.

The digital platform aims to create clarity and make the process more efficient by:

• Guiding through classification of medical devices and in vitro diagnostics
• Identifying which requirements in the regulations apply (MDR and IVDR)
• Generating checklists for safety and performance requirements (GSPR)
• Identifying relevant standards and testing requirements necessary for approval

The platform is currently available to employees at the University of Southern Denmark and in the Region of Southern Denmark until October 2026.

How to access RegMetrics

1. Create an account at www.reg-metrics.com using your @sdu.dk email (without faculty) or @rsyd.dk – use only lowercase letters.
2. Once you have registered, you will receive a confirmation email. Click the link in the email to confirm your email address – this is required to access the premium features. If you do not receive the email immediately, check your spam folder.
3. Click “Get Started” on the homepage.
4. Click “Verify & unlock” to unlock premium features and gain access to RegMetrics.
5. You will receive an email with a "Verification Code" to confirm your email (check your spam folder if you do not see the email in your inbox).
6. Copy the code from the email into the designated field and start your project.