The new In Vitro Diagnostic Regulation (IVDR) aims to harmonise regulatory framework across the European Union (EU) to ensure the safety and performance of devices by placing greater responsibility on manufacturers to demonstrate that their products meet stringent requirements.

For example, under these new directives, manufacturers must ensure proper technical documentation, conformity assessments, quality management requirements and post-market surveillance. Moreover, many in vitro diagnostics (IVDs) have been reclassified under IVDR, creating a need for manufacturers to perform clinical testing on devices that previously may not have required it. To perform clinical testing and generate clinical evidence needed for regulatory approval, most manufacturers will have to develop the ability to collect this data. 

Although the deadline of May 2022 is rapidly approaching, the IVD industry has been slow to make progress towards meeting the elevated regulatory requirements presented by IVDR. This is due to the added expectations for clinical evidence and a greater scrutiny of data, in addition to the requirements for Unique Device Identification (UDI) to improve traceability of devices. Failure to meet these requirements by the deadline may have a profound impact on market access to certain products, and ultimately, patient outcomes. As such, knowing how much clinical evidence is needed for regulatory approval will be critical in terms of cost and time efficiency as manufacturers adjust to IVDR. 

Understanding increased clinical evidence requirements

Because of the reclassification of IVDs under IVDR, different device categories now require different levels of documentation. Due to a perception that there is still a lot of time to transition, some manufacturers are underestimating the amount of clinical evidence required to gain approval. Additionally, with no grandfathering in place for previously certified devices, each device will need to be re-assessed based on their new classification, and manufacturers will need to determine how relevant currently available data is for devices already on the market. With this in mind, manufacturers should review and prioritise their device portfolios to determine next steps as early as possible.

To aid in adjusting to the reclassification of devices under IVDR, the European Commission’s Medical Device Coordination Group (MDCG) published a guidance to define the requirements of sampling for Class B and Class C devices under the new regulations. The guidance elaborates on sampling criteria, including strategies for developing and maintaining a sampling plan.1 Moreover, under IVDR nearly all manufacturers will need to engage the services of a notified body (NB), so this guidance also clarifies what tasks need to be performed by NBs when assessing documentation. To ensure sufficient data is available to be compliant with IVDR, manufacturers may benefit from consulting with the MDCG working group on Clinical Investigation and Evaluation. 

Maintaining performance evaluation reports

In addition to ensuring that enough clinical evidence has been collected and reviewed by the deadline, each device will require a performance evaluation report, which will need to be continually updated. This report should demonstrate three areas: scientific validity, analytical performance and clinical performance. To complete this, manufacturers must assess how much data is available within each of these categories, and then determine how much activity is needed to fill the gaps, as well as what new data will need to be generated. Questions for manufacturers to ask themselves while completing these reports may include:2

  • How much research has been conducted regarding the intended purpose of this device? 
  • What were the results of proof-of-concept studies?
  • How much recorded evidence exists, and how robust is the data?
  • What (if any) clinical performance tests have been performed to prove the device is safe?

IVD manufacturers that have already begun these assessments will be well-prepared to keep existing products on the market, promote new products and gain market share.

Addressing challenges of IVDR

Although larger manufacturers may have a team of in-house experts, many manufacturers may lack the IVD regulatory expertise required to ensure compliance to the IVDR requirements and could benefit from the support of an external CRO partner. 

ICON’s dedicated Medical Device and Diagnostics Research team has over 30 years of experience working with medical device and IVD companies of all sizes. To learn more about how to meet 2022 IVDR deadlines despite pandemic disruptions, read our whitepaper: The IVDR journey.

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  1. European Commission Medical Device Coordination Group. (2019). MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation. 
  2. MedTechViews. (2019).  IVDR: an overview of clinical evidence requirements.