The Regulation (EU) 2017/745 on medical devices is designed to establish a robust regulatory framework, ensuring a high standard of quality and safety for products. This comprehensive regulation addresses crucial aspects such as biocompatibility and the chemical and physical characterization of materials.
These pivotal elements are also outlined in Annex I of the Regulation, focusing on general safety and performance requirements.
Our latest downloadable article, available in both Italian and English, delves into essential aspects related to the evaluation of medical devices, covering key topics such as:
- Biological Evaluation;
- Chemical Characterization;
- Toxicological Risk Assessment;
- Biological Testing;
- Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER).
Explore this insightful resource for a deeper understanding of the regulatory landscape and critical considerations in the assessment of medical devices!
Have a good read!