MDR - PL
2023.05.11 23:47
https://mdrregulator.com/medical-devices-regulation/manufacturers-insurance
Under the new MDR and IVD Regulations, users of medical devices can claim compensation for damage caused by a defective device.
Therefore, according to Article 10(16) of the MDR and Article 10(15) of the IVDR, medical device manufacturers should “have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law”. These measures are to be proportionate to the risk class, the type of medical device and the size of the undertaking.
댓글 0
번호 | 제목 | 글쓴이 | 날짜 | 조회 수 |
---|---|---|---|---|
1819 | mAP 계산법 | WHRIA | 2019.02.24 | 45607 |
1818 | epitope spreading | han | 2006.05.09 | 41100 |
1817 | encfs | WHRIA | 2020.05.17 | 36368 |
1816 | Heinrich Law (1:29:300 Law) | WHRIA | 2007.08.12 | 25040 |
1815 | 일본 주소 [2] | WHRIA | 2008.06.28 | 24048 |
1814 | 사주팔자 프로그램 | 한승석 | 2003.02.16 | 20368 |
1813 | simple adblock | WHRIA | 2012.04.13 | 18174 |
1812 | 도란사민 | WHRIA | 2011.04.19 | 18142 |
1811 | 탤런트 이윤지씨와 함께 | WHRIA | 2010.02.04 | 17082 |
1810 | penicillin | han | 2003.12.10 | 15763 |
1809 | SSH tunnel | WHRIA | 2007.10.01 | 15099 |
1808 | geexbox [1] | han | 2006.12.01 | 14643 |
1807 | 아이피부과 개원 | WHRIA | 2010.01.18 | 14497 |
1806 | 세무회계 | WHRIA | 2010.01.31 | 14442 |
1805 | 증명사진 | WHRIA | 2010.03.14 | 14382 |