IVDR Technical Documentation

The set of IVDR technical documentation is evaluated per device category. IVDR is the new regulatory basis for placing in the market, making it available and putting it into service in-vitro diagnostics medical devices in the European market. In-vitro diagnostics (IVD) is a system where medical devices and reagents are utilized to analyze examples, for example, blood, urine, instruments, tissues, and other body liquids which are derived from the human body to recognize sicknesses, conditions and contaminations.

A portion of the huge innovations consolidated in IVD incorporate polymerase chain response (PCR), microarray procedures, and sequencing innovation, and mass spectrometry, which are utilized for test arrangement. The European Unions In Vitro Diagnostic Regulation (IVDR) 2017/746), which replaces the current In Vitro Diagnostic Directive (IVDD 98/79/EC), presents the risk-based grouping for IVD medical, notwithstanding another necessary technical documentation.

In particular, the seven (7) classification manages under the IVDR have brought about four (4), new risk groups, for IVD product, which decide a device conformity evaluation course and product – explicit technical determination requirements. While grouping is ordinarily the essential worry for IVD supports, when a device falls under the classes B, C or D, it has significant implications for the Notified Body and manufacturer That must be considered.

• We at Operon Strategist help you in the process of making a defined and comprehensive technical file with all product details required for CE marking. 
• We also provide assistance in your process of making technical file and review it at every step for compliance.
• We are the ISO 13485 consultants we’ll help you to create the documentation required for ISO certification. 
• We’ll help you for the CDSCO licensing process and also for the FDA 510k clearance and premarket approval process.

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