Regulatory Daily Summary
Regulatory Daily Summary: What Happened on October 7, 2026
EU adds selected high-risk devices to joint assessment process
The EU began applying joint clinical assessment rules to some medicines in January 2025. Orphan medicines are scheduled to follow in 2028.
Today in brief
The EU began applying joint clinical assessment rules to new oncology medicines and advanced therapy medicinal products in January 2025.1 In June 2026, its member-state coordination group began introducing assessments for selected high-risk medical devices.1
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The rules are scheduled to cover orphan medicines from January 2028 and all other medicines by 2030. The assessment process also covers Norway, the United Kingdom, Switzerland and Ukraine.1