| 20 |
유럽 |
지침 |
Guidance - MDCG endorsed documents and other guidance(MDCG 원문 다운 사이트)
|
2024-05-24 |
| 19 |
유럽 |
소식지 |
[EMERGO by UL - News] Update for EU Amending Regulation and Regulators Who Leverage CE Marking Certificates
|
2024-04-18 |
| 18 |
유럽 |
지침 |
Update - MDCG 2022-9 rev.1 - Summary of safety and performance template - April 2024
|
2024-04-18 |
| 17 |
유럽 |
소식지 |
A Study and dashboard on reprocessing and reuse of single-use-devices in the EU
|
2024-04-15 |
| 16 |
유럽 |
지침 |
MDR/IVDR Language requirements
|
2024-03-26 |
| 15 |
유럽 |
지침 |
[MDCG 2019-7, Rev.1]Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)
|
2024-03-26 |
| 14 |
유럽 |
지침 |
[MDCG 2024-2] Procedures for the updates of the EMDN
|
2024-03-26 |
| 13 |
유럽 |
지침 |
[MDCG 2024-3] Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices
|
2024-03-26 |
| 12 |
유럽 |
소식지 |
[한국보건산업진흥원] MDR Reference Guide 자주하는 질문집 발간
|
2024-02-05 |
| 11 |
유럽 |
소식지 |
[한국의료기기안전정보원] 2023년 유럽(CE) 체외진단 의료기기 IVDR 제도 이해 및 대응 전략 보고서
|
2024-01-19 |
