End-to-End Documentation Support for In Vitro Diagnostic Regulation (IVDR)
Project Summary:
A century-old leading in-vitro diagnostics device manufacturer of surgical blades approached Celegence for end-to-end documentation support to achieve IVDR compliance as per EU 2017/746.
Celegence Solution & Approach:
Celegence conducted a thorough gap analysis according to the In Vitro Diagnostic Regulation (IVDR) and updated technical and performance documents to align with the new regulatory requirements. Additionally, Celegence took steps to remediate the Quality Management System (QMS), develop a risk management plan, conduct performance evaluations, and establish clinical evidence to demonstrate the safety and efficacy of the products.
Furthermore, Celegence implemented a post-market surveillance plan to continuously monitor the safety and performance of its products. This comprehensive approach indicates a commitment to regulatory compliance and ensuring the ongoing safety and effectiveness of the products in the market.
Project Achievements
The manufacturer acted upon the recommendations provided by Celegence regulatory experts to address the identified gaps. Additionally, Celegence was tasked with developing templates and authoring documents for various aspects of technical documentation and regulatory compliance, including classification rationale, Declaration of Conformity (DoC), Performance Evaluation Report (PER), Annual Product Review (APR), Summary of Safety and Clinical Performance (SSCP), Post-Market Performance Follow-up (PMPF), General Safety and Performance Requirements (GSPR), Post-Market Surveillance (PMS) Plan, and PMS Report.
Project Outcomes
The customer expressed satisfaction with both the implementation of the recommendations and the expertise demonstrated by the Celegence expert team. This positive feedback reflects the effectiveness of Celegence in guiding the manufacturer through the regulatory process and ensuring compliance with relevant standards and requirements.
