EU IVD Regulation (IVDR) | MDV-Solve
About IVDR Compliance
The In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) introduces major changes in the regulatory framework for IVDs. Manufacturers must update their technical documentation and quality systems to comply.
Our IVDR services:
- Gap analysis for IVD devices
- Classification support under IVDR
- Performance evaluation plan and report
- Post-market performance follow-up (PMPF)
- Technical documentation file preparation
Related Services
AI Complaint Handling System
Advanced AI-powered system for efficient complaint handling and regulatory compliance.
+ Learn MoreGood Manufacturing Practice (cGMP)
Establish and implement an effective tailored cGMP system in line with requirements.
+ Learn MoreQuality System under EN ISO 13485, US FDA QSR - GMP
The purpose is to enable you to establish and implement an effective tailored QMS system …
+ Learn More