Tuesday, April 16, 2024

RAPS Convergence 2023: Exploring the IVDR and Clinical Evidence Demands

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Emergo by UL consultants recently participated in the Regulatory Affairs Professionals Society (RAPS) Convergence 2023 conference held in Montreal, Canada. This summary discussed the ongoing themes and key points related to the European In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746) that were discussed during the conference.

At the RAPS Convergence 2023, several sessions focused on the IVDR, examining it in the context of legacy In Vitro Diagnostic (IVD) devices and comparing it to the Medical Devices Regulation (MDR, 2017/745). While many fundamental concepts of the IVDR are similar to the MDR, there are unique aspects to IVDs that justify having separate regulations for medical devices and IVDs.

One significant difference is the concept of “indications for use.” In the MDR, this concept is closely related to clinical conditions or disease states. However, in the IVDR, “indications for use” is used interchangeably with “intended purpose.”

Basic Concepts and Differences with the MDR: One observation made at the conference was that the IVDR does not contain MDR Article 22 on systems and procedure packs or Article 23 on parts and components. Still, it’s important to note that an IVD can be a kit or a system. A kit is considered a single device, even if it comprises multiple products, and should bear the CE marking as a single entity.

The intended purpose of an IVD is established through various parameters, including claims, diagnostic applications, use environments, and the types of users. Manufacturers must clearly define the intended purpose to ensure accurate classification of the IVD.

Similarities to the MDR: One common challenge faced by manufacturers under both the MDR and IVDR is the documentation of clinical evidence. BSI data has shown that the most frequent submission nonconformities for IVDs relate to clinical evidence, which is similar to the issues found in clinical evaluations for medical devices.

Manufacturers are required to document performance evaluations and clinical evidence in the Performance Evaluation Report (PER). The IVD must demonstrate its intended clinical benefit, meet safety requirements, and fulfill the intended purpose. The performance evaluation includes three aspects: scientific validity, analytical performance, and clinical performance, which are similar to the medical device Clinical Evaluation Report (CER) process.

The Performance Evaluation Plan (PEP): The PER process aligns with the medical device CER process. A newer aspect for some IVD manufacturers involves conducting and documenting literature searches for both the IVD and state-of-the-art (SOA). SOA is expected for IVDs and can pertain to both devices (Common Specifications, standards, guidance) and medicine (standard of care, disease state). Similar devices selected for SOA must comply with either the IVDR or the legacy In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC).

Concluding Remarks: Meeting the requirements for IVDR Performance Evaluation Plans (PEP) and PER is a complex task. While it may be a new activity for many IVD manufacturers, there is guidance available to help navigate these processes. MDCG 2022-2 guides fundamental concepts related to clinical evidence, and MedTech Europe offers guidance on IVDR and Clinical Evaluation. Additionally, MEDDEV 2.7/1, Rev. 4 provides guidance on the literature search process and protocol, relevant to IVDs as well. With practice and support, IVD manufacturers can improve their PERs.

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