The Clinical Challenge
Addressing Increased Evidence Requirements in the EU IVDR Era
In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European market, regardless of the device’s risk class.
The performance evaluation shall be based on a continuous process and follow a defined and methodologically sound procedure outlined in an established device-specific plan, i.e., the Performance Evaluation Plan (PEP). The identified performance and safety data is then consolidated in the Performance Evaluation Report (PER). These two documents form part of the device’s technical file and are reviewed by the Notified Body during the conformity assessment procedure.
Some of the challenges currently faced by IVD manufacturers in this process include:
- Key Elements of a Performance Evaluation – According to the IVDR, a Performance Evaluation is an “assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device”. Through a Performance Evaluation, the manufacturer must demonstrate that the IVD achieves its intended purpose in accordance with the claimed performance over the lifetime of the device.
- Performance Evaluation of a new IVD device – The Performance Evaluation documentation must include, as part of its plan (PEP), “a description of the state of the art, including an identification of existing relevant standards, Common Specifications, guidance or best practices documents”. Conducting the Performance Evaluation early on in the design and development phase of a new IVD device is therefore of great importance.
- Performance Evaluation of a legacy device – To comply with Article 56 and Annex XIII, Part A of IVDR, manufacturers of legacy devices must invest resources in conducting a Performance Evaluation in line with these new requirements.
With over 20 years of commitment and expertise in In Vitro Diagnostics (IVDs), Veranex works with clients to streamline the performance evaluation process, including through literature research, identification of performance parameters, scientific validity documentation, compliance with analytical performance requirements, assessment of clinical data, validation of marketing claims, and implementation of PEP and PER documentation in line with IVDR and Notified Bodies’ latest guidance.
By watching this webinar, you will:
- Gain an in-depth comprehension of IVDR requirements relevant to Performance Evaluation.
- Understand the importance and benefits of conducting a Performance Evaluation as early as possible in the design and development of a new IVD, or in preparation for the transition of a legacy device to IVDR.
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