Manual on borderline and classification for medical devices under MDR, IVDR (Version. 3)

유럽연합에서 MDR과 IVDR하에서 borderline에 있는 제품의 적용여부와 관련된 문서 개정하여 배포하였다.

 

▶ 개정일자: 2023년 09월 27일

▶ Version. 3

▶ MDR borderlines: medical devices and IVDs

                                 medical devices and medicinal products, including advanced therapy medicinal products (ATMPs)

                                 medical devices and biocides

                                 medical devices and  substances of human origin

                                 medical devices and  cosmetic products

                                 medical devices and  food

                                 medical devices and  personal protective equipment

                                 medical devices and  general consumer products

                                 other medical device borderlines

 

▶ IVDR borderlines: IVDs and medical devices

                                  IVDs and general laboratory equipment

                                 other IVD borderlines

 

Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023) (europa.eu)

Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)

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