Hyperplan
MDR Certification
*Software undergoing certification – currently not a CE-marked device (planned for the end of 2025).
Maximum safety for patients and users through mandatory MDR certification
Medical Device Regulation (MDR 2017/745) ensures that a product meets the highest safety and performance requirements.
The certification process comprises several steps, compliance with which is confirmed by the CE marking and is mandatory for medical devices used in clinical practice.
The use of a non-certified medical device on a patient is a legal violation that has consequences for both the manufacturer and the user.
- Intended use and specification
- Benefit-risk analysis and risk management
- Usability
- IT security and cybersecurity
- Verification and validation
- Clinical evaluation and clinical trial
- Post-market surveillance
