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.
Artigos recentes
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- Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
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- EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE PROGRAMME : Audit Checklist
- MDCG 2023-3: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
- Ongoing guidance development and deliverables of MDCG Subgroups – March 2023*
- Artificial Intelligence in Drug Manufacturing.
- Guideline on computerised systems and electronic data in clinical trials