EMA on Friday released a new document summarizing the major and minor changes to the guidance:
Artigos recentes
- European Commission Newsletter on medical devices | September 2023
- Good clinical practice (GCP) inspection procedures : ANNEX III TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: COMPUTER SYSTEMS
- EUDAMED Release notes Production v 2.12 September 2023.
- Regulatory Considerations for Prescription Drug Use-Related Software SEPTEMBER 2023
- EUDAMED GUIDELINE: Guidelines on Data Exchange with EUDAMED Production v 2.12 September
- INFARMED Esclarecimentos: Medicamentos essenciais de natureza crítica
- Labeling for Biosimilar and Interchangeable Biosimilar Products
- IMDRF/PMD WG/N58 FINAL: 2023 (Edition 2) Personalized Medical Devices – Regulatory Pathways