France Latest Articles
Life Sciences and Healthcare
EU device package envisages more support for 'orphan' and breakthrough products and flexible access in crises
In-house exemptions, 'orphan grandfathering', 'sandboxes' and crisis derogations aim to balance unmet needs with safety
New
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04/02/2026
Read time
8m
Life Sciences and Healthcare
Draft EU medtech revisions adjust importer and distributor roles to support supply chain resilience
Digital obligations, leaner repackaging rules and new shortage reporting tools may evolve supply chain responsibilities
30/01/2026
Read time
7m
Life Sciences and Healthcare
EU MDR and IVDR poised to remain main framework for medical AI in draft AI interface reforms
Lex specialis treatment, integrated notified body reviews and clarified duties are designed to limit overlapping regulation of medical AI
28/01/2026
Read time
6m
Life Sciences and Healthcare
EU digital by default medtech plans signal shift in submissions, product information and online sales
E-submissions, digital documentation and clarified Eudamed and UDI duties to steer medtech towards fuller digitalisation
23/01/2026
Read time
6m
