유럽 MDR, IVDR

[EU, MDR] Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period

MD우야 2023. 8. 27. 09:00
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  • MDR 전환기간 동안 대상제품의 유럽시장 판매, 서비스 가능여부를 판단할 수 있는 흐름도 
  • 대상제품: Legacy device, Class III custom-made implantable devices
  • 근거: Article 120 MDR, as ameded by Regulation 2023/607

Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period (europa.eu)

 

Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period

Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period

health.ec.europa.eu

 

 

 

 

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