Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I
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- ICH E6(R3) update – New training materials available (Jan 2026)
- 2025 EMA’s key recommendations in human medicines.
- Guiding principles of good AI practice in medicine development
- European Pharmacopoeia publishes new data quality framework
- FDA GUIDANCE DOCUMENT: Clinical Decision Support Software! Guidance for Industry and Food and Drug Administration Staff
- Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products Guidance for Industry
- The Use of Generative Artificial Intelligence in Research
- FDA GUIDANCE ON General Wellness: Policy for Low Risk Devices