- MDR - MDCG 2022-4 가이드라인 발표
- 등록일2022-03-03
2022년 2월 22일 Medical Device Coordinatoin Group (MDCG)는 MDCG 2022-4, ' Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD.” 를 발표했습니다. 본 가이드라인에서는 기존 MDD나 AIMDD 의료기기 제품에 대해 MDR 제120조 (Article 120)에 따라 감시제도(surveillance)를 어떻게 적절히 전환해야 하는지에 대해 의료기기 제조사와 Notified Body에게 중요한 정보를 제공하고 있습니다.
더 자세한 정보는 NAMSA 웹사이트 (https://namsa.com/mdcg-2022-4-guidance-released/) 에서 확인하실 수 있습니다.
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New Medical Device Coordination Group (MDCG) guidance document, MDCG 2022-4: “Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD,” was published on the 16 February 2022. It provides information for both manufacturers and Notified Bodies (NBs) concerning the transition requirements for legacy medical devices and may be found by clicking here.
The new MDCG guidance compliments previous transition guidance detailed in:
• MDCG 2019-10 rev. 1 “Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC”
• 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 2021-25 “Regulation (EU) 2017/745 - application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC”
An Excel comparison table, “QMS MDD/MDR,” has been made available in an annex of the MDCG guidance. The correlation matrix can be used to show which MDD or AIMDD requirements are covered by the MDR.