MedDream is now certified as CE Class IIb!

2021-06-10

category-icon

2021-06-10

MedDream By Softneta DICOM Viewer Certified CE Class IIb

MedDream CE class has been changed from IIa to IIb!

From the certificate HZ 1992126-1 issuance date (2021-06-02) medical software MedDream CE class has been changed from IIa (according to MDD) to IIb (according to MDR).

Medical software MedDream is now intended to aid in diagnosis by visualization various medical images, video and signals, measuring data in DICOM images and management DICOM images, when the patient is not in life-threatening state of health, time is not critical for medical decision and no major therapeutic interventions are required.

The main changes are described in the table below:

Difference Class IIa Class IIb
Intended use MedDream is intended for use as a diagnostic, review and analysis tool by trained professionals such as radiologists, physicians, clinicians. Note: The MedDream is not intended for intensive care monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient. MedDream is a software intended to aid in diagnosis by visualization various medical images, video and signals, measuring data in DICOM images and management DICOM images, when the patient is not in life-threatening state of health, time is not critical for medical decision and no major therapeutic interventions are required.
EU Regulation MDD MDR
Rule applied Rule 10:

Active devices intended for diagnosis.

Rule 11:

Software intended to provide information which is used to take decisions with diagnosis and therapeutic purposes, if such decisions have an impact that may cause a serious deterioration of a person’s state of health or a surgical intervention.


MedDream versions changed to IIb class: 7.5.2,
7.5.3, 7.6.0, 7.7.0 and later. Other maintained versions are not changing. Information for users is available here.

Read more about all MedDream registrations and certifications here.

Read more about MedDream DICOM Viewer.