Tag: performance evaluation

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How to Get Your QMS Ready for IVDR (25 May 2025)

With less than a month to go before the requirement kicks in for a valid Quality Management System (QMS) complaint to the EU IVD Regulation (IVDR), most IVD manufacturers who have placed IVDs on the European market (or any region where you are using the CE mark, including the UK) should be ready for the change.

If you are not one of them, you need to start thinking about the below very quickly!

A Strategic Approach for IVD Companies
The IVDR represents one of the most significant regulatory shifts for IVD manufacturers in recent history. With stricter requirements for quality management systems, technical documentation, and post-market surveillance, achieving IVDR compliance demands a comprehensive transformation of your existing quality processes. Here’s how to prepare your QMS effectively.


Understand the IVDR QMS Requirements
The IVDR significantly enhances the QMS expectations compared to the previous IVD directive (IVDD).


The regulation specifically references ISO 13485:2016 as a presumption of conformity, making this standard the foundation for IVDR-compliant quality systems. The EU harmonised version of this standard, EN ISO 13485:2016A11:2021, includes the handy Annex Z correspondence between the IVDR and ISO 13485


Gap Analysis: Your First Critical Step
Before implementing changes, conduct a thorough gap analysis of your current QMS against IVDR requirements:

  • Review existing procedures against IVDR Article 10 (manufacturer obligations), Annex I (general safety and performance requirements), and Annex IX (QMS and technical documentation assessment)
  • Assess your product classifications under the new risk-based system (Classes A through D)
  • Identify documentation gaps, particularly around clinical evidence and performance evaluation
  • Evaluate your post-market processes for alignment with intensified surveillance requirements

A structured gap analysis provides a clear roadmap of required changes and helps prioritize critical areas.


Key QMS Modifications for IVDR Compliance

1. Risk Management Integration
The IVDR requires risk management to be integrated throughout your QMS, not just during design phases:

  • Update your risk management procedure to align with ISO 14971:2019
  • Establish risk controls that span the entire product lifecycle
  • Implement benefit-risk analysis methodologies
  • Create documentation that demonstrates continuous risk assessment


2. Performance Evaluation System
Develop a robust performance evaluation system that includes:

  • Scientific validity assessment for each analyte
  • Analytical performance verification
  • Clinical performance studies (where applicable)
  • A performance evaluation plan and report (PER)
  • Documented procedures for updating performance evaluation throughout the product lifecycle


3. Post-Market Surveillance System
Strengthen your post-market surveillance (PMS) system to include:

  • A PMS plan specific to each device
  • A PMS report (for Class A and B devices) or periodic safety update report (PSUR) for Class C and D devices
  • Trend reporting for incidents
  • Processes for implementing field safety corrective actions (FSCAs)
  • Integration of PMS data into risk management and performance evaluation.

4. Supply Chain Oversight
The IVDR places greater responsibility on manufacturers for supplier and distributor oversight:

  • Develop procedures for qualifying and monitoring critical suppliers
  • Implement appropriate supplier agreements covering IVDR requirements
  • Establish clear roles and responsibilities for economic operators
  • Create systems for verifying unique device identification (UDI) implementation across the supply chain

5. Person Responsible for Regulatory Compliance (PRRC)
Designate a qualified person responsible for regulatory compliance who will:

  • Ensure product conformity is appropriately verified
  • Maintain technical documentation and EU declarations of conformity
  • Fulfill post-market surveillance obligations
  • Ensure reporting requirements for serious incidents are met

6. Documentation Strategy for IVDR
Documentation requirements under IVDR are extensive. Implement a systematic approach:

  • Update your quality manual to reflect IVDR-specific requirements
  • Revise existing internal procedues to incorporate new requirements and references
  • Develop new procedures for gaps identified in your analysis
  • Create templates for technical documentation aligned with Annexes II and III
  •  Implement document management systems capable of maintaining the necessary documentation throughout the product lifecycle


Conclusion: A Transformed Approach to Quality
IVDR compliance isn’t simply about updating documents, it represents a fundamental shift in how IVD manufacturers approach quality management. By systematically addressing each aspect of the regulation, you can transform your QMS from a documentation-focused system to a truly integrated approach that enhances product safety and performance.

It is recommended that you liaise with your certification/notified body, they may have further guidance on what they would like to see, and how to lay out specific documents and QMS infrastructure before any auditing takes place. Remember it is in everyone’s best interest to ensure manufacturers are compliant, including notified bodies and competent authorities. If you don’t have a notified body, this is a great place to start!


The investment in your QMS now will not only ensure regulatory compliance but also strengthen your market position through improved product quality and enhanced patient safety. Begin your IVDR transformation today to ensure continued access to the European market and position your organization for future growth in an increasingly regulated industry.

You can speak to us by booking in our calendar here, or email [email protected] to discuss investing into your QMS, whether that be QMS hosting or uplifting, IVDeology can support.

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Performance Evaluation: The critical component in bringing your product to market and keeping it there

Abingdon Health and IVDeology Ltd have decades of  In-Vitro Diagnostic (IVD) regulatory compliance experience where our teams support your entire product journey from ‘cradle-to-grave’ to ensure you are getting your product to market in the quickest timeframe possible, reducing cost and strain, and keeping it compliant through its lifetime.

Abingdon Health also offer full-service contract development and manufacturing for lateral flow assays, bringing your idea to commercial success, with the benefit of an integrated regulatory and quality approach.

In our latest blog, Candice Vendettuoli Head of RAQA at Abingdon Health covers the importance of getting your Performance Evaluation (PE) right to streamline your route to market, and ensuring compliance to keep it there.

What is Performance Evaluation?

The In Vitro Diagnostic Regulation (IVDR) 2017/746, which entered into force in May 2017 and applied in May 2022, has introduced significant changes to the way in vitro diagnostic (IVD) medical devices are regulated in the European Union. One of the key aspects of this regulation are the new requirements for documenting the performance evaluation of IVD medical devices using a prescriptive document structure mandated within the Regulation.

Performance evaluation under IVDR is expected to be a continuous process throughout its entire lifecycle of the device. This process is crucial for ensuring that the device meets upon entry to the market, and continues to meet, the intended clinical benefits and safety as claimed by the manufacturer.

The mandated documents should be written to provide a comprehensive and structured narrative for the reviewer giving a clear and logical explanation of how the device was developed, verified and validated against the intended use/purpose claimed by the manufacturer. These documents are a requirement of the Technial Documentation described in Annex II and forms an essential part of the submission to the Notified Body

The mandated documents, unless they can justify why such studies are not applicable are as follows:

Performance Evaluation Plan

Ideally written during the early development of the device and updated regularly, this document has content prescribed within Annex XIII section 1.1 of the Regulation. Manufacturers are required to establish and regularly update the performance evaluation plan that outlines the device’s characteristics and performance, as well as the process and criteria used to generate the necessary clinical evidence.

Scientific Validity

The concept of scientific validity under the In Vitro Diagnostic Regulation (IVDR) 2017/746 is a cornerstone in the performance evaluation of in vitro diagnostic (IVD) medical devices. It refers to the association of an analyte with a clinical condition or physiological state, which must be substantiated with a medical-scientific rationale evidenced through a systematic literature search

Analytical Performance

Analytical performance refers to a device’s ability to accurately and reproducibly measure an analyte, marker, or molecule, which is a strictly technical performance without the need for correlation with a targeted pathology.  There are analytical performance characteristics mandated within Annex I section 9.1(a) including assessing the accuracy, sensitivity and specificity,

Clinical Performance

Clinical performance is defined as the ability of a device to yield results that are correlated with a particular clinical condition, physiological or pathological process, or target population and intended user. Manufacturers must demonstrate clinical performance through one or more of the following:

  • Clinical performance studies, carried out according to the IVDR requirements on clinical performance studies described in Articles 57-77, Annex XIII section 2 and, if applicable, Annex XIV for studies other than those using leftover samples
  • Scientific peer-reviewed literature on the device under evaluation, or
  • Published routine diagnostic testing.

Performance Evaluation Report

The report (also known as a ‘PER’) provides a summary of the clinical evidence collected through the previous reports. An assessment can then be made against the current state of the art in diagnostics and medicine that a positive benefit-risk ratio of using the device for its intended purpose has been met and then all data has been collected.

This rigorous approach ensures the reliability and effectiveness of in vitro diagnostic devices within the European Union, with the primary aim of protecting public health by requiring high levels of safety and performance of these devices to be evidenced.

For manufacturers, understanding and adhering to the IVDR’s performance evaluation requirements is vital for successful market introduction of their IVDs in the European Market. It involves a comprehensive understanding of the general safety and performance requirements (GSPR), as well as the specific guidelines on performance evaluation stipulated in Article 56 of the IVDR.

Abingdon Health and through its subsidiary IVDeology Ltd , can offer support and guidance to help companies navigate these new and complex EU Performance Evaluation requirements.

We offer a full-service solution for all your regulatory and quality requirements including:

Contact Us today to book some time with one of our industry experts to understand how we can support you bringing your product to market and keeping it there.