20 Chapter 1 In the new regulation, software is specifically addressed. Software includes all programs and other operating information used by a hardware device. Software can be standalone, such as a computer program or a medical app, or part of a medical device such as an infusion pump. If an app is defined as a medical device, it must meet corresponding standards to ensure safety, quality and performances. One of the required standards is the application of CE-marking. CE-marking The manufacturer is responsible for determining the risk class of the medical app and for the application of the Conformité Européenne (CE)-marking. The mark guarantees that the medical device is in concordance with the MDR and that the appropriate conformity assessment procedures have been followed in order to determine so. The CE-marking is valid in all members of the EEC. It is important to note that it is a compliance mark, and not a quality mark. Every medical device has an intended purpose, wherefore it was specifically designed by the manufacturer. The conformity assessment procedure is specifically followed for the intended purpose; therefore, the CE-mark is only applicable for the intended purpose. The conformity assessment procedure depends on the risk class to which the medical device belongs. Class I indicates the lowest risk and class III indicates the highest risk. To determine the risk category of a medical device, the manufacturer should follow the “Implementing rules” in chapter II and the “Classification rules” in chapter III of Annex VIII of the MDR. If a medical device belongs to risk class I, the manufacturer itself can assess the new medical device and apply CE-marking when all requirements from the conformity assessment are met. Whenever a medical device belongs to any other risk class, only a relevant Notified Body (NB) can perform the conformity assessment procedure. Notified bodies are designated organisations to assess the conformity of products, and in this specific scenario, medical devices. The member states of the European Union can designate an organisation within their own state. The Nando-database (New approach notified and designated organisations) lists all notified bodies that are designated to perform conformity assessment procedures according to the MDR.16 It is important to realise, that products that were already on the market under the MDD will not be revoked, however they should meet the MDR when the current CE-marking expires.
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