02-29
2024
Possible second call for EU reference lab for high-risk IVD

01-29
2024
Amending Regulations (EU)2017/745 and (EU)2017/746

01-29
2024
CDRH 2023 Annual Report

01-22
2024
Circulatory System Devices Panel of ACMD Meeting Announcement

01-22
2024
MDR - Language Requirements for Manufacturers (January 2024)

01-15
2024
FDA (510(k)) Submissions for Devices Labeled as Sterile

01-15
2024
Monitoring the Availability of MD&IVD Medical Devices in the EU

01-11
2024
MDCG 2023-7-Guidance on Article 61(4)-(6) MDR

01-11
2024
Use of RWE to Support Regulatory Decision-Making for MD

01-11
2024
MDCG 2019-7-Rev.1 Guidance on article 15 of the MDR and IVDR


