Regulatory
Rapporteur

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November 2024  |  Vol. 21  |  No. 10

EDITORIAL

Improving health outcomes through regulatory excellence

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By Kornelia Grein, Sobhey Nassar and Marie Uguen

MEDICAL DEVICES/IVDs

MD1/IVD1/HM5: COMBINE project: A new era of combined clinical trials in Europe

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By Erica Cypas

MEDICAL DEVICES/IVDS

MD2/IVD2: Unravelling AI as a medical device - Insights into the EU AI Act and other global perspectives

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By Margareth Jorvid

MEDICAL DEVICES/IVDS

MD3: The impact of MDR/IVDR and its effect on future developments of policies, manufacturers and inspectorates

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By Maïté Barthel

MEDICAL DEVICES/IVDS

MD4/IVD4: UK MDR - Current requirements and future perspectives for medical devices and in vitro diagnostics

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By Mehryar Behizad

MEDICAL DEVICES/IVDS

MD5/IVD5: Responsible and experienced PRRCs for MDR and IVDR

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By Rachel Drapela

ANNUAL LECTURE

The TOPRA annual lecture: Status of global health 

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By Margareth Jorvid