지침,참고문헌 | MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database (Annex VI, Part A Section 2 and Part B of the Medical Device Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Device Regulation (EU) 2…

MDCG 2018-7_languages_en.pdf (332.5K) [27]

General principles
In consideration of the following:
- In accordance with Article 28(3) MDR and Article 25(3) IVDR, the core data elements to be provided to the UDI database shall be accessible to the public,
- Annex VI Part C of the MDR and IVDR on the UDI System requires explicitly in its section 5.10 that the user interface of the UDI database shall be available in all official languages of the Union and that the use of free- text fields shall, however, be minimized in order to reduce translations,
- one of the main declared purposes of the European database on medical devices (Eudamed) as per Recitals 43-46 and Article 33(1a) of the MDR and Recitals 40-43 of the IVDR is to enable the public (including the healthcare professionals) to be adequately informed about devices placed on the market,
it is essential that the information in the UDI database is publicly available and easily understandable by any European citizen.