IVDR compliance deadline: how to prepare your Quality Management System (QMS) by May 26, 2025
With the entry into force of the Regulation (EU) 2017/746 (IVDR), manufacturers of in vitro diagnostic (IVD) medical devices face a series of new regulatory obligations.
Among these, a key requirement is the implementation of a Quality Management System (QMS) in accordance with Article 10(8) of the Regulation.
For all manufacturers intending to market IVD devices in the European Union, the compliance deadline is May 26, 2025.
In this article, we explain what this obligation entails and how manufacturers can prepare in time.
What does Article 10(8) of the IVDR require?
Article 10(8) of the IVDR mandates that every manufacturer must establish, document, implement, and maintain a Quality Management System (QMS) appropriate to the type of devices produced. The QMS must cover all stages of the device’s lifecycle, from design and development to production and post-market activities. This requirement applies to all manufacturers, regardless of the risk class of their devices.
What should an IVDR-Compliant QMS include?
An IVDR-compliant QMS should cover several key areas critical for ensuring product quality and regulatory conformity, including:
- Regulatory Compliance Strategy: A documented approach to meet applicable regulatory requirements across the device lifecycle.
- Risk Management Procedures: Processes to identify, analyze, control, and monitor risks related to the device.
- Performance Evaluation: Systems for conducting and documenting clinical performance studies and evaluations.
- Post-Market Surveillance (PMS): Procedures to collect and analyze data on device performance after market launch.
- UDI Assignment and Management: Systems to manage the Unique Device Identification requirements.
- Communication with Authorities: Protocols for timely and effective communication with regulatory authorities.
- Corrective and Preventive Actions (CAPA): Structured methods to address non-conformities and continuously improve processes.
Compliance with the EN ISO 13485:2016 standard is highly recommended to align efficiently with IVDR expectations.
May 26, 2025: A decisive deadline for IVDR compliance
For devices that benefit from the IVDR’s transitional provisions, having a fully operational and documented QMS by May 26, 2025 is essential. Failure to comply may result in:
- Loss of eligibility for extended transition periods
- Disruption of market access within the European Union
- Mandatory withdrawal of non-compliant devices
Timely action ensures continued commercialization and market presence in the EU.
How to prepare your QMS for IVDR compliance
To meet the QMS obligation under the IVDR, manufacturers should:
- Review and update their Quality Management Systems according to IVDR requirements.
- Integrate specific procedures for post-market surveillance and UDI compliance.
- Ensure full operational implementation of the QMS and maintain thorough documentation.
- Consider obtaining ISO 13485:2016 certification to demonstrate compliance effectively.
Conclusion
Implementing a QMS in accordance with Article 10(8) of the IVDR is a critical and non-negotiable step for manufacturers aiming to maintain their access to the European market.
With May 26, 2025 approaching rapidly, manufacturers must act now to ensure full compliance and secure their future in the IVD sector.
If you require support to align your Quality Management System with IVDR requirements, our team is ready to assist you with tailored consulting services.
Contact us today and take the next step toward secure and compliant market access.
