European Commission: Introduces New Rules for Notified Bodies Under MDR and IVDR
- Sharan Murugan
- 7 hours ago
- 3 min read
The European Union has taken another major step toward strengthening the efficiency, predictability, and consistency of medical device and in vitro diagnostic (IVD) certification processes.
On 4 May 2026, the European Commission adopted Commission Implementing Regulation (EU) 2026/977, which was subsequently published in the Official Journal of the European Union on 5 May 2026. The regulation establishes uniform quality management and procedural requirements for conformity assessment activities carried out by notified bodies designated under:
Regulation (EU) 2017/745 on Medical Devices (MDR)
Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)
The regulation aims to address long-standing concerns regarding inconsistent notified body practices, unpredictable certification timelines, and varying conformity assessment procedures across the European Union.
The regulation applies to notified bodies designated under MDR and IVDR that perform conformity assessments for:
Medical devices
In vitro diagnostic medical devices
Harmonization of Conformity Assessment Practices
One of the primary objectives of the regulation is to standardize the way notified bodies conduct conformity assessments.
Historically, notified bodies have used different methodologies, timelines, and documentation expectations, resulting in inconsistent experiences for manufacturers.
The new regulation seeks to improve:
Predictability
Transparency
Consistency
Reliability
across conformity assessment procedures within the EU market.
Standardized Timelines for Certification Activities
A key feature of the regulation is the introduction of more structured timelines for conformity assessment activities.
The regulation outlines expectations related to:
Initial application review timelines
Audit scheduling and execution
Product assessment timelines
Recertification timelines
Interruption and “stop-the-clock” mechanisms
These measures are intended to reduce uncertainty for manufacturers and improve planning for certification activities.
The regulation also introduces clearer procedural expectations regarding interruptions in timelines, ensuring greater transparency when additional information or corrective actions are required.
Greater Transparency in Costs and Quotations
The European Commission identified significant variability in the way notified bodies provide quotations and cost estimates for certification services.
Under the new regulation, notified bodies will be expected to improve transparency regarding:
Certification costs
Scope of services
Assessment activities
Expected timelines
The aim is to provide manufacturers with clearer visibility into the conformity assessment process and associated financial commitments.
Quality Management System Requirements for Notified Bodies
The regulation introduces uniform quality management requirements that notified bodies must implement as part of their operations.
These requirements are intended to ensure that notified bodies maintain:
Consistent assessment methodologies
Adequate procedural controls
Effective monitoring systems
Proper documentation practices
Competent personnel oversight
The implementing regulation also reinforces the importance of robust internal quality systems to support reliable and scientifically sound conformity assessments.
Monitoring and Performance Oversight
The regulation requires notified bodies to monitor and evaluate the performance of their conformity assessment activities. These measures are designed to support continuous improvement and provide regulators with greater oversight of notified body performance.
Impact on Medical Device Manufacturers
The regulation is expected to have significant implications for manufacturers of medical devices and IVDs operating within the European Union. Structured timelines may help manufacturers plan submissions, audits, and recertifications more effectively.
Impact on Notified Bodies
Notified bodies will need to adapt their internal systems and procedures to align with the new regulatory requirements.
This may involve updates to:
Quality management systems
Documentation practices
Assessment workflows
Internal monitoring procedures
Timeline management systems
Failure to comply with the new requirements could affect the designation status of notified bodies under MDR and IVDR.
Relationship with MDR and IVDR Reforms
The implementing regulation forms part of broader EU efforts to stabilize and improve the MDR and IVDR framework.
The European Commission has been working on measures to:
Reduce certification bottlenecks
Prevent device shortages
Improve market access
Enhance regulatory predictability
The new implementing regulation complements these broader initiatives by addressing operational inconsistencies among notified bodies.
Reference
For complete details, refer to the official regulation:
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