Performance Evaluation Report (PER) – IVDR
It is very critical to assess the performance of any In-Vitro Diagnostic device before being commercially sold. The European Union has taken extra measures to ensure that no non-conforming or poorly performing device enters the market by modifying the existing directive with a regulation, i.e. the EU 2017/746 Regulation under which the performance and the post-market activities have become more stringent. The new European IVD Regulation (EU IVDR), specifies the requirements of effectively carrying out this performance evaluation and submit the Performance Evaluation Report (PER).
The ultimate aim of performing this performance evaluation is to analytically and clinically prove that the device supports the manufacturer’s intended use. As per Article 56 of EU IVDR, the performance evaluation of any IVD device shall be determined based on the following:
- Scientific validity
- Analytical performance
- Clinical performance
IVDR Performance Evaluation Report Criteria
The IVDR Performance Evaluation Report (PER) is a critical component in ensuring that In-vitro Diagnostic (IVD) devices meet the stringent requirements set by the European Union (EU) for market entry. Under the EU 2017/746 Regulation, the performance and post-market monitoring of IVD devices have been significantly enhanced to safeguard public health. To comply with the EU IVDR, manufacturers must submit a well-documented performance evaluation that supports the intended use of their IVD devices.
The primary objective of the IVDR performance evaluation report is to analytically and clinically prove that the device meets the manufacturer’s intended use. The report must demonstrate that the IVD device performs as expected in real-world scenarios, providing reliable and accurate results that benefit patient care. To meet the regulatory requirements, the evaluation is based on four essential criteria as outlined in Article 56 of the EU IVDR:
- Scientific Validity: This involves validating the scientific principles upon which the device is based. Manufacturers must provide evidence that the device is scientifically sound for its intended purpose.
- Analytical Performance: This refers to how accurately and precisely the device measures the target analyte. It includes testing aspects like sensitivity, specificity, and reproducibility.
- Clinical Performance: This evaluates how well the device performs in a clinical setting. It involves ensuring that the device produces clinically meaningful results when used with real patient samples.
- Post-market Surveillance: Continuous monitoring after the device is marketed to ensure ongoing compliance with performance standards and address any potential risks identified post-sale.
A comprehensive performance evaluation report IVDR is essential for the approval of IVD devices. Manufacturers must provide substantial clinical evidence to demonstrate that the device meets the performance criteria established by the EU IVDR. The report is a key part of the technical documentation required for Notified Body (NB) assessment and approval. As part of the performance evaluation report medical device process, manufacturers need to outline the clinical data collected, the testing performed, and how the device supports its intended purpose throughout its lifecycle.
To streamline the process, manufacturers often use a performance evaluation report IVDR template. This template helps ensure that all required sections are addressed systematically and that the report meets regulatory expectations. Whether you are preparing a new device for the market or updating an existing one, using a performance evaluation report IVDR template can simplify the documentation process and ensure that no critical information is missed.
For manufacturers, it is crucial to recognize that the IVDR performance evaluation report must be regularly updated to reflect any new clinical data, post-market surveillance findings, and changes to the device’s design or intended use. This dynamic approach helps maintain regulatory compliance and ensures the safety and efficacy of IVD devices in healthcare settings.
Key Roles of CROs in Performance Evaluation under IVDR
Clinical Research Organizations (CROs) play a pivotal role in ensuring the success of performance evaluations for In-Vitro Diagnostic (IVD) devices under the EU IVDR. These organizations are crucial in supporting manufacturers with comprehensive services that facilitate the preparation, assessment, and submission of the performance evaluation report IVDR, which is a critical component for obtaining regulatory approval and CE marking.
One of the primary responsibilities of CROs is to assist in the preparation of the performance evaluation report IVDR by reviewing scientific literature, performing data collection, and conducting clinical studies. This data is then analyzed to assess the clinical and analytical performance of the IVD device in alignment with the requirements outlined in the EU IVDR. CROs help develop a performance evaluation report IVDR template that serves as a framework for structuring the findings, ensuring it meets the regulatory standards for submission to Notified Bodies (NB).
Moreover, CROs support manufacturers in the design and implementation of clinical studies. They work closely with medical professionals and institutions to generate the necessary evidence that demonstrates the device’s effectiveness and safety. This evidence is critical for compiling a compliant performance evaluation report medical device that will be included in the device’s technical documentation.
CROs also help in the continuous monitoring of post-market performance, ensuring that any issues arising after the device is marketed are appropriately documented and addressed. The IVDR performance evaluation report submitted to regulatory authorities must include an ongoing assessment of the device’s clinical use, and CROs ensure that this process is well-documented and managed efficiently.
By leveraging their expertise, CROs facilitate the creation of a compliant performance evaluation report IVDR template, allowing manufacturers to navigate the complexities of IVDR compliance and ensure that their devices meet the rigorous standards required for market approval.
In conclusion, CROs are indispensable partners in the IVDR performance evaluation report template development, ensuring manufacturers meet all regulatory requirements while effectively managing the performance evaluation process.
Performance Evaluation Report IVDR: Expertise
Maven offers expert services in preparing the IVDR performance evaluation report, ensuring that In-Vitro Diagnostic devices meet the stringent requirements set by the EU IVDR. Our team conducts a thorough analysis, including scientific validity, analytical, and clinical performance evaluation, to create a robust report that supports the device’s intended use in the healthcare sector. We also provide an IVDR performance evaluation report template to guide manufacturers through the process, ensuring compliance with regulatory standards. Our systematic approach to performance evaluation guarantees that your device remains aligned with EU regulations, facilitating a smooth path to market approval.
Performance Evaluation Report IVDR: Advantages
The Performance Evaluation Report (PER) under the EU IVDR ensures that In-Vitro Diagnostic devices meet strict regulatory standards. It helps manufacturers demonstrate scientific, analytical, and clinical evidence to support device safety and effectiveness. This systematic evaluation enhances market confidence, ensures compliance, and facilitates smoother regulatory approvals for IVD products.
Within the Performance Evaluation Report (PER), the manufacturer must demonstrate satisfactory clinical evidence that supports the intended use for the device in healthcare sector and this needs to be rationalised throughout the life cycle of the device for supporting clinical evaluation of medical device. For successful IVDR compliance, manufacturers of IVD medical devices are required to be vigilant all through the performance evaluation process, that includes planning, collecting and assessing the clinical evidence data and preparing and submitting the Performance Evaluation Report (PER), as part of the IVDR technical documentation for NB assessment.
Maven performs a systematic review of the scientific literature, checks the adequacy of existing testing performed and develops performance evaluation plan along with a compliant Performance Evaluation Report (PER).
For further information refer the following MDCG endorsed documents:
FAQ:
Yes, performance evaluation is an ongoing process under the EU IVDR. It continues throughout the lifecycle of the In-Vitro Diagnostic device, ensuring it meets the manufacturer’s intended use. Regular updates to the Performance Evaluation Report (PER) are required based on new clinical evidence and post-market performance data.
A Performance Evaluation Report (PER) for medical devices, specifically under the EU In-Vitro Diagnostic Regulation (IVDR 2017/746), is a comprehensive document that analytically and clinically demonstrates that an In-Vitro Diagnostic (IVD) device meets its intended purpose. It assesses the device’s scientific validity, analytical performance, and clinical performance to ensure safety, effectiveness, and reliability before and after market entry. The PER is a mandatory part of the technical documentation required for regulatory approval and ongoing post-market surveillance, helping manufacturers prove that their device performs as expected and complies with stringent EU regulatory standards.
A Performance Evaluation Report (PER) is essential for CE marking under the EU IVDR as it provides evidence that an IVD device is safe, reliable, and performs as intended. It includes scientific validity, analytical performance, and clinical performance data. The PER supports regulatory compliance, especially during Notified Body reviews for Class B, C, and D devices. It ensures that labeling claims are justified and forms the basis for post-market performance follow-up (PMPF). Without a robust PER, CE marking approval may be delayed or denied. It is a critical document demonstrating compliance, safety, and effectiveness for EU market access.
The key elements included in a Performance Evaluation Report (PER) under the EU IVDR are:
1. Scientific Validity: Evidence validating the scientific principles underlying the device and confirming it is scientifically sound for its intended purpose.
2. Analytical Performance: Data demonstrating how accurately and precisely the device measures the target analyte, including sensitivity, specificity, and reproducibility.
3. Clinical Performance: Evidence showing the device performs reliably in a clinical setting, providing clinically meaningful results with real patient samples.
These elements collectively demonstrate that the device meets its intended use, supports patient care, and complies with the regulatory requirements of the EU IVDR.
A Performance Evaluation Report (PER) is required for IVD devices under EU IVDR (2017/746) and focuses on scientific validity, analytical performance, and clinical performance of the diagnostic test. A Clinical Evaluation Report (CER), under EU MDR (2017/745), is for medical devices and assesses clinical safety and performance using clinical data to confirm the device works as intended in patients. While both aim to demonstrate device effectiveness, PER is test-centric (lab-based metrics), and CER is patient-centric (clinical use). In essence, PER validates IVD performance, whereas CER validates medical device clinical safety and efficacy.
Yes, Maven offers expert services to assist manufacturers in preparing a fully compliant Performance Evaluation Report (PER) under the EU IVDR. Our team conducts thorough assessments of scientific validity, analytical performance, and clinical performance to ensure your In-Vitro Diagnostic device meets all regulatory requirements. We provide tailored support including systematic literature reviews, evaluation of clinical evidence, and development of a robust performance evaluation plan and report. With our expertise and IVDR performance evaluation report templates, we help streamline the documentation process and facilitate smooth regulatory approval and CE marking.
