지침,참고문헌 | MDCG 2018-5 UDI Assignment to Medical Device Software

MDCG 2018-5_software_en.pdf (343.5K) [24]

In accordance with Annex VI, Part C of the Medical Device Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR), only software which is commercially available on its own as well as software which constitutes a device in itself shall be subject to UDI requirements.