DE/CA304 - Marktüberwachung Medizinprodukte Bayern
MDR Class I Software Statistics
These charts compare this competent authority with averages across all competent authorities. This is useful because some competent authorities enforce different interpretations of the EU MDR, e.g. regarding whether software as a medical device can be classified as MDR class I. So, if you see a competent authority which has a below-average fraction of MDR class I software devices, this might be an indicator that they interpret things differently. Other factors might influence this though, too.
Software Classifications: This CA vs. All
This is a comparison of the MDR classification distribution of software devices for this competent authority (blue color, left side) versus all competent authorities (red color, right side).
This CA oversees 77 software devices (1107 exist in total).
Software Fraction
This shows the fraction of how many devices are software devices within the competent authority's oversight. A high software fraction means that the competent authority oversees a higher-than-average number of software devices, relatively speaking. A low number can mean that companies are avoiding this competent authority for software devices, e.g. due to subjective "classification decisions". These numbers don't imply causality though - a low number might also be caused by simply not many software companies existing within the area of this competent authority.
These values are usually very low - software devices only make up less than 1% of total medical devices.
MDR Class I Software Devices
Click here to view the MDR class I software devices of this competent authority.