Requirements for CE-marking of apps and wearables

Abstract

Depending on the intended use, apps and wearables can be medical devices. In such cases, the manufacturer has to provide evidence that the requirements stated in directive93/42/EWG are fulfilled. Depending on the classification of the medical device, several so-called conformity assessment procedures are possible. Once the conformity assessment procedure has been finished successfully, the manufacturer attaches the CE-marking to the product. This assures that all requirements of the directive have been fulfilled and the manufacturer is therefore authorized to put the product onto the market in all member states of the European union. In this article, the possible and practical conformity assessment procedures for apps and wearables are described and their implementation is outlined.For medical devices with sufficiently high-risk classification, the manufacturer has to involve aNotified Body. For the conformity assessment procedure according to annexII, the manufacturer implements afull quality management system and compiles technical documentation. These are supervised and evaluated by Notified Body audits. Especially for startups, it is important for the development of apps and wearables to implement a quality management system early and to fulfill the regulatory requirements, for example, related to the software life-cycle model. This also includes considering accompanying processes during development like risk management, usability engineering, and clinical evaluation.Additionally, it should be pointed out, that according to the new medical device regulation almost all apps will fall at least into class IIa. Thus, the involvement of aNotified Body in the related conformity assessment procedures would be required. Apps that have already been put onto the market as classI devices, and are now upgraded to ahigher class, need the approval of anotified body starting from 26 May 2020.