The European Commission released three documents:
MDR – UDI and device data sets to provide in EUDAMED
IVDR – UDI and device data sets to provide in EUDAMED
EUDAMED UDI Device Data Dictionary
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Recentes
- Guiding principles on the use of large language models in regulatory science and for medicines regulatory activities
- IMDRF Document Implementation Report
- Acceptable Media for Electronic Product User Manuals
- FDA final guidance on ‘Electronic Submission Template for Medical Device De Novo Requests’
- Cyber security in the health and medicine sector: a study on available evidence of patient health consequences resulting from cyber incidents in healthcare settings
- ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms – Scientific guideline
- EUDAMED user guide NRDs (Custom made and Old devices) for the Vigilance module
- MDSAP AUDIT APPROACH UPDATED. Revision Date: 2024-08-06.