EU MDR Class I Software Devices

View 412 EU MDR Class I Software Devices on BEUDAMED, the Better Database on Medical Devices. Class I software devices are generally considered lower risk under the EU MDR and often do not require notified body involvement unless specific classification rules elevate the device. Manufacturers are responsible for meeting general safety and performance requirements, maintaining proportionate technical documentation, and conducting appropriate clinical evaluation and risk management.

Software-specific compliance focuses on a documented software development lifecycle, cybersecurity controls, and risk management consistent with standards such as IEC 62304 and ISO 14971. Maintain post-market surveillance, vigilance reporting, and device registration obligations, and use BEUDAMED to verify listings, manufacturer details, and regulatory status for transparency and market oversight.