Surgeons for sharing anonymized patient treatment data

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Reference no: EM132819529

A medical device company in Europe is developing stand alone web based software used by surgeons for sharing anonymized patient treatment data during their meetings. What should the regulatory affair professional advice for this software?

a. It does not need to be CE marked as it has no medical purpose

b. It is stand alone software, so it does not need to bear a CE marking

c. It is stand alone software, so it needs to bear a CE marking

d. It needs to be CE marked as it used to store patient data

Reference no: EM132819529

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