The European Commission released an update to its manual on classifying “borderline” medical devices featuring clarifications as to the medical device status and classification of on twelve additional types of products.
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- FDA eMDR – Electronic Medical Device Reporting
- ACT EU Draft Guidance on Clinical Trials During Public Health Emergencies
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- Sponsor Frequently Asked Questions Clinical Trial Information System (CTIS) Frequently Asked Questions (FAQs) on the Sponsor’s workspace
- The new CTIS Sponsor Handbook (v6.2, March 2026)
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