IVDR (in vitro diagnostic medical devices Regulation) compliance and CE marking
Compliance with the IVDR is crucial for manufacturers of in vitro diagnostic medical devices seeking access to the Union Market. The in vitro diagnostic medical devices Regulation (EU) 2017/746 (IVDR) establishes requirements designed to enhance safety, performance, and traceability in the diagnostic sector. This guide provides a general outline of the IVDR requirements, IVDR CE marking, and how Certification Experts can assist with navigating the compliance requirements to ensure your product meets the Union Market entry requirements.
Per 26 May 2022 the in vitro diagnostic medical device Regulation replaces the in vitro diagnostic medical device Directive (IVDD).
What is the in vitro diagnostic medical devices Regulation (IVDR)?
The IVDR (Regulation (EU) 2017/746) has introduced strict regulatory requirements to increase oversight on in vitro diagnostic medical devices on the Union Market. To comply with the IVDR, manufacturers must align with rigorous requirements for among others, clinical evidence, traceability, and risk management. IVDR compliance ensures that products are held to high safety and performance requirements essential for patient safety and regulatory acceptance.
Key Areas of the IVDR
- Patient Safety: The IVDR mandates thorough testing and performance validation to prioritise patient safety.
- Risk Classification: Devices are classified based on risk, with higher-risk devices subject to more stringent controls.
- Performance evaluation: Robust analytical and clinical evidence is required to demonstrate that the device meets its intended purpose.
- Traceability: Traceability from purchasing raw materials up to the distribution and use of finished devices
- Post market surveillance requirements: Proactive collection and review of experience gained from devices on the Union market to verify safety and performance.
IVDR & CE Marking
To affix the CE-mark on in vitro diagnostic medical devices, manufacturers must show that their device meets the general safety and performance requirements outlined in the IVDR. This process involves documentation and assessments confirming that a device is safe and performs as intended. Certification Experts provides guidance throughout this process, ensuring that all aspects of the conformity procedure are met, such as:
- Technical Documentation: Complete and accurate documentation under IVDR Annex II and III to demonstrate a safe and functional design.
- Clinical Evidence: Supporting data to verify the device’s safety and efficacy for its intended use.
- Performance and Safety Validation: Robust testing and performance evaluation in compliance with the IVDR requirements.
- Implementing a quality management system under ISO13485:2016
Certification Experts can assist with each phase of conformity procedure to ensure that your device meets these complex requirements in the Union Market.
Full-service IVDR compliance.
Achieving an IVDR compliant status
Navigating the IVDR can be challenging given the technical and regulatory requirements involved. Certification Experts provides IVDR consultancy to support manufacturers in understanding the requirements and preparing for compliance. Our approach includes:
- Comprehensive Documentation Review and Management: Assistance in creating and structuring technical files and the quality management system in line with the IVDR CE marking requirements.
- Performance Evaluation Guidance: Support in organizing and presenting clinical data required for IVDR compliance.
- Risk Management: Establishing an effective risk management process that meets regulatory expectations.
- Continual Compliance Support: Ongoing support to maintain compliance as regulatory expectations evolve.
With Certification Experts, manufacturers benefit from nearly 20 years of experience in regulatory compliance, simplifying IVDR consulting and ensuring a streamlined path to IVDR CE marking.
All the answers you might need!
The MDR (Medical Device Regulation) and IVDR (in vitro diagnostic medical device Regulation) are regulatory frameworks within the Union market. MDR applies to medical devices, while IVDR specifically covers in vitro diagnostic medical devices.
The IVDR is the Union market regulatory framework that governs in vitro diagnostic medical devices, establishing requirements for safety, performance, and traceability within the Union market.
The IVDR applies across all 27 EU member states, 3 EEA countries (Norway, Iceland, Liechtenstein) and Turkey, ensuring uniform safety and performance requirements for in vitro diagnostic medical devices placed on the Union Market.
Full-service product compliance
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