New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference 

The Association for the Advancement of Medical Instrumentation (AAMI) has been hosting the AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation for over three decades, keeping us up-to-date with the latest developments in health technology standards and regulations. This premier event is for medical device experts who want to stay informed on the latest developments, changes, and trends in health technology standards and regulations. In October 2022, after a two-year absence due to the pandemic, conference attendees convened in person in Arlington for a dynamic and practical review of recent changes to the regulatory landscape and lessons learned from the pandemic on the global medical device marketplace. 

One of the objectives of the conference was to discuss the newly implemented European In Vitro Diagnostics Regulation (IVDR) requirements for in vitro device (IVD) manufacturers. Some of the major updates to the IVDR requirements discussed at the conference included:  

  • The expansion of the definition of IVDs to include software and applications that are part of IVD instruments, which are now subject to regulatory oversight. 
  • The IVDD list-based IVDR classification has been replaced with a clear set of classification rules for assigning risk categories to each device. Under the new system, approximately 80% of devices will fall into risk classes B, C, or D, requiring some level of Notified Body (NB) oversight, significantly increasing the regulatory burden for IVD manufacturers and their NBs.  
  • The use of laboratory developed tests (LDTs) in clinical and central testing laboratories has been restricted, and clinicians cannot use LDTs if a certified IVD is commercially available. 
  • IVD manufacturers and related organizations must update their quality systems, increase clinical evidence and regulatory strategy planning, and address post-market surveillance requirements under the IVDR. 

The conference aimed to discuss practical knowledge and best practices for navigating these new requirements. Criterion Edge’s own Dr. Sarah Chavez, Director of IVD and Scientific Writing Services, was among the panel of speakers who presented a comprehensive overview of clinical evidence planning, detailing how to demonstrate data sufficiency to meet NB expectations. One of the major key takeaways from her talk included a discussion on the new IVDR requirements in terms of clinical evidence. 

Moving from IVDD to IVDR: Adjusting to the Shift in Clinical Evidence Requirements 

Evaluation and analysis of data to determine the scientific validity, analytical performance, and clinical performance of a device is achieved primarily through clinical evidence. Clinical evidence is best understood as clinical data and performance evaluation results of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefits, when used as intended by the manufacturer.  

Performance evaluation is an ongoing process of collecting and evaluating clinical data and evidence and the Performance Evaluation Report (PER) reflects the outcome of this process as a snapshot in time and therefore, a clearly defined procedure for this collection of clinical evidence is vital. 

In her presentation Dr. Chavez provided an overview of the steps involved in clinical evidence planning and strategies necessary to satisfy data sufficiency requirements Notified Bodies are looking for in their reviews. 

Read the four steps and helpful tips here


Criterion Edge has the expertise and resources to write your performance evaluation reports or help you and your team navigate the ever-changing IVDR landscape. Ready for a free consult? 

About the Blog

In this blog, we share our insights and experiences to help companies build quality, scalability, and flexibility into their regulatory writing.  We hope you find it insightful. For questions, please contact info@criterionedge.com.

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