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Increased Use of Medical Apps
The healthcare sector is increasingly using medical apps on smartphones and tablet PCs to support disease management. Chronically ill patients are a typical example of a user group of medical apps. This development is only made possible by the increasing performance and distribution of mobile devices. Moreover, users can simply access this type of medical software via online ressources as app stores.
MDR Compliance Harder Than Ever
The new EU Medical Device Regulation (MDR) will apply from 26 May, 2020. It will significantly tighten the regulatory requirements for medical devices in Europe. In particular, this is true for software as a medical device on its own (stand-alone software) such as a medical app. As a result of the new classification rules, there will hardly be any stand-alone software that can be assigned to the lowest risk class I. But for higher risk classes you must involve a Notified Body and invest a higher effort to proof conformity. This includes, for example, clinical evaluation, risk management and safety and performance requirements. Hence, the regulatory burden for manufacturers of medical apps to achieve MDR compliance will increase considerably.
Standards Under Revision
Parallel to the changes in the legal requirements, international standardization organizations are working on revising existing standards and developing new standards to support manufacturers in certifying their products.
In this presentation you will be introduced to the MDR route of conformity for medical apps using a mole assessment app as a concrete example.