Having due regard to the current practice toward registering medical device products that are placed on the market under the Medical Device Regulations and Certificates thereof through the Product Tracking System (PTS) as effected from 06/12/2017 by virtue and mandate of the official determination letter of 06/02/2017 with ref. E.1967 for the Opening Of Medical Device Registration Screens of the PTS;
Acknowledging the need observed during reviews held in the communication of 05/02/2020 titled “Notice 2020/KK-2 Amending Notice 2019/KK-9 on Applications For Registration of Medical Devices and Certificates Thereof” and in the pace of the recent and/or concurrent technical revisions in the design and deployment structure of the PTS, the Agency’s electronic system for registering and tracking medical device products that are placed on the market and made available, aimed solely at affording compliance with the novel requirements imposed by the introduction and entry into force of the new legislation of the European Union on Medical Devices (i.e., the MDR and IVDR), for altering and amending certain requirements as laid down therein, and, especially adding new requirements by expanding the content through insertion of words and phrases in a specific number of parts thereof,