The main updates of the Third Version Guidance from MedTech Europe on Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation (IVDR).
This 129-page eBook is a valuable resource for stakeholders in the IVD industry, regulators, and authorities, offering updated examples, improved clarity, and flow, and updated references and diagrams. The IVDR contains provisions that can be open to different interpretations, and this brochure aims to help stakeholders understand the IVD Regulation better.
MDx summarize the key updates to the MedTech Europe Regulatory eBook Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation (IVDR) Version 3, published in February 2023, emphasizing the relevance of the CDx, clinical performance studies, similar/equivalent concepts, and benefit-risk determination.
- Companion Diagnostics (CDx) is a crucial area covered in the Third Version of the eBook, with the term mentioned in 20 of the 129 pages. CDx developers can benefit from the guidance provided to establish the outcomes for analytical and clinical performance, cut-offs, and clinical benefits. The eBook helps determine the necessary level of clinical evidence and data for scientific validity, plan sources for clinical performance data, and conduct clinical performance studies. Clear flowcharts are included about the submission process with the European Competent Authorities, and there is an explanation about comparators and follow-on CDx.
- The eBook provides additional information on the use of clinical data coming from outside the EU to support performance evaluation claims for devices on the EU market. This update will help manufacturers understand how to comply with regulatory requirements and ensure the safety and efficacy of their IVDs.
- The guidance covers the intended purpose/use of IVD devices, which now includes updated examples of intended use to include a ‘specific medical purpose,’ as defined by the regulations. This update has been made to help manufacturers better understand the intended use of their products and to ensure that they are in compliance with the latest regulatory requirements. Additionally, a new COVID19 example has been added to provide guidance on how to approach the development of IVD products related to the ongoing pandemic.
- The chapters on clinical evidence and scientific validity have been reformatted to improve the flow of information and make it easier for manufacturers to understand the requirements for each section. These updates are designed to provide greater clarity and ensure that all relevant information is presented in a logical and organized manner.
- The chapter on evidence from published testing has been updated to allow for additional scientific rigor when reviewing published experience gained from routine diagnostic testing. This update is intended to help manufacturers and regulatory bodies better understand the scientific validity of published data and how it can be used to support claims about the safety and efficacy of IVD products.
- The eBook’s Chapter on equivalence has been updated and now focuses on performance evaluation concepts of equivalence and similarity. The tool for demonstrating equivalence has also been updated, offering manufacturers more options for demonstrating compliance with regulatory requirements. The Chapter on clinical evidence has been reformatted and includes information on scientific validity, definition, and how to establish it.
- The chapter on documentation has been updated slightly to ensure a consistent approach to the cyclical nature of product development. This change is designed to provide greater clarity and ensure that all relevant information is presented in a logical and organized manner.
- A new chapter on benefit-risk determination has been added, which brings in text from the original Chapter 3 on clinical benefit. This update acknowledges that manufacturers may wish to make claims for specific patient management actions, which would make the IVD more aligned with the intended purpose of a CDx. The chapter provides guidance on how to approach benefit-risk determination and ensure that all relevant information is considered when evaluating the safety and efficacy of IVD products.
In conclusion, the latest updates to the regulatory guidelines surrounding IVD devices have brought about several changes in the way manufacturers and regulatory bodies approach the development and evaluation of IVD products. These updates are intended to provide greater clarity and ensure that all relevant information is presented in a logical and organized manner. Manufacturers and regulatory bodies alike should familiarize themselves with these changes to ensure that they are in compliance with the latest regulatory requirements.
The MedTech Europe Regulatory eBook on Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation (IVDR) is a valuable resource for anyone involved in the IVD industry, particularly those interested in Companion Diagnostics (CDx) and Clinical Evidence requirements. MedTech Europe is making the Third Version available to be downloaded free of charge from its website, making it an essential resource for anyone involved in the IVD industry.
How can MDx help?
MDx CRO is a leading quality, regulatory and contract research consulting company dedicated to the medical device and diagnostic sectors.
With the introduction of the IVDR, the requirements for IVD and CDx manufacturers and laboratory developed tests (LDTs) have grown significantly. Whether you are a health institution in the EU or a commercial laboratory outside of the EU, our MedTech team can assist you in developing a compliance strategy and will be with you every step of the way.
Our IVD clinical evidence services include:
- Regulatory strategy: comprises categorization evaluation, analysis of intended purpose, assessment of technical documentation requirements, and strategic assessment of regulatory needs with an emphasis on decreasing the compliance cost.
- Development of QMS processes to fulfill EU IVDR criteria.
- Evaluation of CDx approach
- Gap evaluation of your QMS system
- Clinical Performance Process Medical writing
- Development of technical documentation for IVDs in-house of Class D
- Checklist creation and completion for GSPR
- Help with applications to notified body
- Assistance with competent authorities
- ISO 14971:2019 implementation and gap analysis
- Analysis of ISO 13485:2016 gap and implementation
- ISO 15189:2022 implementation and gap analysis
Please reach out today for a consultation with our team of IVD experts.