The European Commission has launched a guideline entitled “Guidelines on the
Qualification and Classification of Stand Alone Software Used in Health within the
Regulatory Framework of Medical Devices” (hereafter MEDDEV 2.1/6), which help
manufacturers to determine the regulation of their product.
The following criteria will help the manufacturer to know whether their software is
considered as medical devices/IVD.
–– The product is a software;
–– The software is a standalone software;
–– The software performs an action on data which is different from storage, archival,
communication, simple search of lossless compression;
–– The action of the software is for the benefit of individual patients;
–– The software is specifically intended by its manufacturer to be used for any purposes
listed in the definition of medical device, i.e.:
–– diagnosis, prevention, monitoring, treatment or alleviation of disease;
–– diagnosis, monitoring, treatment, alleviation, or compensation for an injury or handicap;
–– investigation, replacement or modification of the anatomy or of a physiological process;
–– control of conception.
Digital health technologies should also meet the new regulation of MDR and IVDR, the
MDR will add new classification criteria for medical devices software from 26 May 2020.
These new regulations will make changes on the classification of Class I software in EU.
Apart from the new implication mentioned, digital health technologies manufacturers should
consider the General Data Protection Regulation (GDPR), which will be effective replacing
the actual directive in EU from 25 May of 2018. This will increase the responsibility and
liability of personal data saved in the software.
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