지침,참고문헌 | MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

MDCG 2020-3 Guidance on significant changes amp; annexes.pdf (1.0M) [43]

Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD1
1 Introduction
Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) states that devices which have a valid certificate issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR under certain conditions and no later than 26 May 2024.
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