지침,참고문헌 | MDCG 2019-5 Registration of legacy devices in EUDAMED

MDCG 2019-5_legacy_devices_registration_eudamed_en.pdf (304.0K) [30]

This document deals with registration of devices, which can continue to be placed on the market under Directive certificates by virtue of Article 120(3) of Regulation 745/2017 (MDR), and Article 110(3) of Regulation 746/2017 (IVDR) after the relevant MDRs application dates. Those products are, for the purpose of this document, referred to as “legacy devices”1. All following considerations, which are made in relation to the MDR shall apply to the IVDR, mutatis mutandis.
Art 120(3) of the MDR lays down that the requirements of the MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to legacy devices placed on the market after the application date of the MDR in place of the corresponding requirements of the Directives.
The MDR is not explicit in requiring that these “legacy devices” are subject to relevant UDI obligations. The MDR device registration requirements (Annex VI Part A Section 2 and Part B that are complementary) make the Basic UDI-DI and UDI-DI the access keys for device-related information in the future Eudamed, which is reflected in the database design. Therefore, any registration of a device is normally possible in Eudamed only if a proper Basic UDI-DI and UDI-DI are assigned to the device and registered in the database together with the other device-related data.