Placing an In Vitro Diagnostic (IVD) device on the European Union market requires compliance with the EU In Vitro Diagnostic Regulation (EU IVDR 2017/746)—one of the most comprehensive and stringent regulatory frameworks in the world. The IVDR significantly increases expectations for clinical evidence, performance evaluation, quality management, and post market follow up.

Masuu Global Solutions supports IVD manufacturers in navigating these complex requirements through strategic consulting, structured documentation development, and seamless coordination with Notified Bodies (NBs). Our goal is to help you achieve timely CE marking and maintain full IVDR compliance throughout the lifecycle of your IVD product.

EU IVDR Compliance – Overview

The EU IVDR replaces the former IVD Directive (IVDD 98/79/EC) and sets a harmonized regulatory standard across the EU Member States and EFTA nations.

Effective 26 May 2022, IVDR introduces:
  • Stricter classification rules
  • Expanded NB involvement (affecting most IVDs)
  • Strengthened performance evaluation requirements
  • More rigorous PMS/PMPF expectations
  • Comprehensive documentation obligations

Under IVDR, even long established IVDs must undergo new conformity assessments. Manufacturers must ensure updated technical files, complete performance evaluation reports (PER), validated clinical evidence, and structured post market processes.

Masuu Global Solutions assists manufacturers in preparing all IVDR required documentation and aligning with new conformity pathways to ensure uninterrupted access to the EU market.

IVDR Transition Timeline

As IVDR is phased in, manufacturers must meet mandatory requirements based on device risk classification. Once fully implemented:
  • Nearly all IVDs require Notified Body review
  • CE marking must follow IVDR’s updated conformity assessment rules
  • Technical documentation must meet Annex II & III requirements
  • Performance evaluation must include scientific validity, analytical performance, and clinical performance
Manufacturers must proactively prepare for:
  • New classification categories
  • PER and PMPF documentation
  • Vigilance and trend reporting
  • QMS enhancements
  • NB shortage related delays

Masuu helps brands create structured transition plans to ensure compliance without business disruption.

General Requirements for IVDR Certification

To secure CE marking under IVDR, manufacturers must complete:
  • Comprehensive technical file compilation following Regulation (EU) 2017/746
  • Preparation of a Performance Evaluation Report (PER)
  • Development and execution of PMPF activities (Annex XIII Part B)
  • Post market surveillance (PMS) and vigilance documentation (Article 82 requirements)
  • Updated labeling, UDI, and risk management documentation

Masuu provides complete support for these requirements, ensuring your documentation is complete, accurate, and aligned with IVDR’s enhanced standards.

Masuu’s IVDR Compliance Services – Expertise

Transition Planning & Gap Assessment

  • IVDR transition planning tailored to your product portfolio
  • Gap analysis for General Safety & Performance Requirements (GSPR)
  • Identification of missing evidence and technical documentation needs

Technical Documentation Support

  • Full compilation and updates of technical files
  • Annex II & III aligned documentation structure
  • Preparation of IFUs, labeling, QRIs, and user manuals

Performance Evaluation Documentation

  • Scientific validity reports (SVR)
  • Analytical performance reports
  • Clinical performance evaluation reports (PER)
  • Compilation and integration of all performance evidence

Post Market Performance Follow Up (PMPF)

  • PMPF plan & report creation
  • Real world data collection and analysis strategies
  • Integration with PMS, vigilance, and risk management activities

Post Market Surveillance (PMS)

  • PMS plan development
  • PMS reporting and updates
  • Article 82 vigilance reporting

Regulatory Writing & Documentation

  • Editing and creation of all IVDR related documents
  • Labeling, inserts, UDI data, and controlled translations

Additional Expertise

  • NB interaction and deficiency handling
  • Multidisciplinary regulatory support
  • Training and process enhancement
  • Ongoing regulatory intelligence and updates

Advantages of Working with Masuu Global Solutions

  • Assured, end to end IVDR compliance and CE marking support
  • Deep regulatory understanding of IVDR’s high impact requirements
  • Strong project management structure to meet deadlines and eliminate delays
  • Access to internal NB facing experts for feedback ready documentation
  • Cross functional teams specializing in IVD, medical devices, and regulatory strategy
  • Consistent quality across all deliverables—on time, every time
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