A third party review - why?
Third party review of IVDR performance evaluation documents
Are you an IVD manufacturer preparing your IVDR performance evaluation (PE) documents for conformity assessment by a Notified Body (NB) under the EU IVDR 2017/746? If so, have you considered a third party review of your PE documents prior to submission? This could save you time and money with your NB.
Why have a third party review?
A third-party reviewer serves as an independent expert assessing your documents primarily for regulatory adherence but also considering key requirements such as clarity and scientific content. This is done using up to date regulatory standards and guidance. The role requires specific third-party skills, including expertise in relevant regulations, industry standards and technical knowledge. The reviewer will give an unbiased assessment and make suggestions for improvement and regulatory compliance while maintaining impartiality at all times.
A recent EU survey of NBs (Feb/25) revealed that no IVDR applications, received by NB’s, were considered >75% complete and 35.7% of applications were less than 25% complete. Therefore only 64% of applications were considered 25-75% complete on first submission. A PE third party review would identify these common high-level omissions, which waste time, and additionally would identify detailed omissions at the level of the review which potentially add additional hours and rounds of questions to the NB review. All impacting the cost and timelines associated with the conformity assessment!
Key steps in the PE third party review process
Several critical steps define the third-party review process, each designed to systematically evaluate your documents.
Key steps include:
- Initial intake and definition of requirements: Confirming document completeness, and establishing review objectives.
- Detailed examination of technical documentation: Detailed assessment to support certification – Performance Evaluation and Clinical Evidence, Post-market surveillance and post-market performance follow-up, Product verification by EURL (Class D and some Class C only).
- Assessing document usability: Ensuring clear, unambiguous conclusions, even where data may be unfavourable.
- Reporting and Feedback: Delivering a structured summary with key findings, key outstanding issues, clarifying questions and recommendations to ensure compliance.
Detailed examination of your documents by a third party:
A third-party review will ensure your documentation meets the requirements of Annex II, Section 6 and Annex XIII, Sections 1-3 of the EU IVDR 2017/746.
Key requirements, in addition to the scientific content, will be considered as they play an important role in meeting the requirements of the regulation:
- logical ordering,
- overall coherence and readability,
- length and relevance of individual areas,
- consistency of approach across documents,
- meets the requirement for the manufacturer to specify & justify how they will demonstrate the state of the art (SOTA) safety and performance of the device,
- narrative approach to clearly and simply tell the story of how the performance of the device will be demonstrated,
- clear and robust statements.
Assessing document usability:
Reviewer friendly drafting or usability should consider:
- the NB will not infer conclusions, ensure they are clear and unambiguous,
- be open and transparent do not try to hide information or duck problems – describe them and how you have chosen to address them,
- be aware the NB expects to see unfavourable data, they consider all devices have some e.g. limitations.
Reporting and feedback by a third-party reviewer:
Any issues identified during third party reviews will require a structured approach to summarise key findings, key outstanding issues and recommendations to ensure compliance.
Conclusion
The NB wants to see good technical documentation and safe and effective devices on the market. They cannot certify ambiguity. The goal of the manufacturer is to prepare documents that can be read by a reviewer without any need for further discussion or questions – do not underestimate what a challenge this is.
Test the documents by giving them to an independent third-party reviewer and save yourself time and money!