Commission Implementing Regulation (EU) 2026/977 introduces harmonized requirements for notified bodies conducting conformity assessments under MDR and IVDR. The Regulation addresses inconsistencies in assessment practices, timelines, quotations, and recertification procedures, creating a more efficient and predictable certification framework.
Key requirements
- Quotation Requirements: Standardized information requirements before issuing quotations to improve transparency and consistency.
- Application Review and Contracting: Harmonized procedures for application evaluation, scope definition, and contractual arrangements.
- Assessment Timelines: Introduction of maximum timelines for certification, substantial change assessments, and recertification activities.
- Parallel Assessments: Encouragement of parallel quality management system audits and technical documentation reviews to improve efficiency.
- Substantial Change Assessments: Clear procedures for evaluating significant changes affecting certified devices or quality systems.
- Recertification Requirements: Consistent processes for planning, reviewing, and issuing recertification decisions.
- Quality Management Systems: Requirements for notified bodies to maintain effective quality systems, resource management, and continuous improvement processes.
- Communication and Documentation: Enhanced information exchange, recordkeeping, and traceability throughout the conformity assessment lifecycle.
- Consistency and Equal Treatment: Measures to reduce variability among notified bodies and provide more predictable certification outcomes for manufacturers.
By establishing uniform procedures and timelines, the Regulation strengthens consistency, transparency, and efficiency in conformity assessment activities, supporting timely market access for compliant medical devices and IVDs across the EU.
As EU conformity assessment requirements continue to evolve, medical device companies should proactively assess their certification strategies to avoid unnecessary delays and maintain market access. Qualtech team can support your MDR and IVDR compliance journey across Europe with practical guidance and local expertise. Contact us now!