We are pleased to announce a significant achievement for BDR after years of intensive work: the attainment of the CE IVDR 748704 certificate.
This certificate signifies compliance with the stringent safety and performance requirements outlined in European Regulation 2017/746. In this article, we will delve into the details of what this certification entails and how it impacts both our company and our customers.
The Significance of CE IVDR 748704 Certificate
The CE IVDR 748704 Certificate marks a crucial milestone in the regulatory landscape for BDR. However, its scope extends beyond; it also benefits our distributors and users by subjecting our products to comprehensive performance and risk management assessments.
- Greater Scientific Evidence and Transparency
The primary goal of this European regulation is to achieve a higher level of scientific evidence, transparency, and traceability throughout the supply chain. This ensures a product of the highest quality.
- Regulatory Harmonization
Furthermore, the regulation aims to harmonize standards to eliminate discrepancies that were emerging among European Union member countries. This streamlines and standardizes procedures for our customers.
- Rigorous Performance Testing
One key aspect of this certification is the exhaustive demonstration of the analytical and clinical capabilities of our products through rigorous performance testing. This guarantees the accuracy and reliability of our reagents.
- Stricter Quality Controls
The new regulation imposes stricter quality controls compared to the previous one. This ensures that our products meet the highest quality standards.
- Detailed Documentation
The certification entails a significant increase in the required documentation for each product, from the Quality Management System (QMS) to associated technical documentation. This ensures complete traceability and security.
- Traceability and Post-Market Monitoring
Moreover, new requirements regarding traceability and post-market monitoring are established. This ensures that any issues are effectively and promptly addressed.
In the coming weeks, we will be updating information in this regard, including everything related to the impact this new regulation will have on the documentation associated with each kit.
If you would like to receive additional information on how this certification affects our products or have any questions, please do not hesitate to contact us. We are here to assist and provide the guidance you need.