EU IVDR Support
Support performance evidence and post-market performance activities under the EU IVDR framework.
Needed wherever an IVD's performance evidence package must be built, strengthened or maintained under EU IVDR — from initial performance evaluation through PMPF.
Bioexcel integrates scientific validity, analytical and clinical performance evidence into a coherent Performance Evaluation Report, then maintains it through PMPF and Notified Body queries.
What Bioexcel Provides
- Performance Evaluation Plan / Report
- Clinical performance study data
- PMPF plan and report
Integrates with IVD clinical performance studies, reference testing and PMPF activities.
Preparing for More Predictable Conformity Assessments
Commission Implementing Regulation (EU) 2026/977 introduces more uniform requirements for Notified Body quotations, assessment stages, timelines and clock-stops. Manufacturers will still need complete, consistent and review-ready evidence to avoid delays attributable to documentation or evidence gaps. Bioexcel supports manufacturers through evidence-gap assessment, clinical and performance documentation, post-market evidence and Notified Body query remediation.
Source: European Commission — Commission Implementing Regulation (EU) 2026/977
Last Reviewed: 27 August 2026
Technical Reviewer: Named EU MDR / IVDR expert
This is a summary only and does not constitute regulatory advice. Regulatory requirements evolve — verify current requirements against the official EU source before relying on this content.
Typical Engagement Model
Discuss Your EU IVDR Support Requirement
Share your program details and Bioexcel can help scope the right level of support.