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.
- 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
- 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
- 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
- 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
Frequently Asked Questions
CE marking under EU IVDR requires manufacturers to classify the IVD, establish an appropriate quality management system, prepare technical documentation under Annex II and III, complete performance evaluation, address applicable General Safety and Performance Requirements, and follow the required conformity assessment procedure. Most IVDs also require Notified Body involvement under the IVDR framework.
IVD classification under IVDR follows the regulation’s risk-based classification framework. The classification determines the applicable conformity assessment procedure and level of regulatory oversight. Manufacturers should assess the intended purpose and characteristics of the IVD against the applicable classification rules before determining the required evidence, technical documentation, and Notified Body involvement.
Under IVDR, Notified Body involvement has expanded significantly compared with the previous IVDD framework, and most IVDs require assessment by a Notified Body. The exact conformity assessment route depends on the IVD’s classification and applicable requirements. Manufacturers should determine the classification before identifying the appropriate conformity assessment pathway.
IVDR technical documentation must follow the requirements of Annex II and Annex III and demonstrate conformity with applicable safety and performance requirements. Depending on the IVD, documentation can include device information, risk management, performance evaluation evidence, labeling, UDI information, PMS documentation, and other technical evidence supporting the device’s intended purpose.
A Performance Evaluation Report (PER) consolidates evidence demonstrating the scientific validity, analytical performance, and clinical performance of an IVD. It is a key component of IVDR compliance and must be supported by appropriate evidence. Manufacturers need to ensure that the performance evaluation is adequately documented and aligned with the device’s intended purpose.
IVDR performance evaluation must address three key areas: scientific validity, analytical performance, and clinical performance. Manufacturers need to generate or compile appropriate evidence for each area and integrate the findings into the performance evaluation documentation. The required evidence depends on the IVD, its intended purpose, classification, and applicable regulatory requirements.
Transitioning from IVDD to IVDR requires manufacturers to reassess their IVD under the new classification and conformity assessment framework. The transition can require updated technical documentation, performance evaluation, quality management processes, labeling, UDI information, PMS, and PMPF documentation. Manufacturers should identify gaps between existing IVDD documentation and current IVDR requirements.
IVDR strengthens post-market surveillance and vigilance requirements for IVD manufacturers. Manufacturers must establish appropriate PMS processes and maintain required vigilance documentation, including applicable reporting and trend-monitoring activities. PMS findings should also support ongoing risk management and evaluation of the device’s performance and safety throughout its lifecycle.
Post-Market Performance Follow-up (PMPF) is a structured process for collecting and evaluating performance data from an IVD after it is placed on the market. Under IVDR, manufacturers must address PMPF requirements where applicable and document appropriate plans and reports. PMPF activities contribute to ongoing performance evaluation, PMS, vigilance, and risk management.
IVDR introduces enhanced requirements for IVD labeling, device information, and Unique Device Identification (UDI). Manufacturers must ensure that applicable labeling and instructions for use contain the required information and that UDI requirements are addressed within the technical documentation and regulatory processes. These requirements should be reviewed as part of the IVDR conformity assessment.