The EU In Vitro Diagnostic Medical Devices Regulation 2017/746. represents a fundamental shift in the regulatory oversight of in vitro diagnostic medical devices. Introduced to strengthen patient safety, clinical evidence, and performance transparency, the IVDR has significantly increased regulatory expectations compared to the former IVDD. One of the most impactful changes is the reclassification of the majority of IVDs, resulting in far greater involvement of Notified Bodies and a substantial increase in the depth and scrutiny of conformity assessments.
Correct classification under the IVDR is the foundation of a successful conformity assessment strategy. The IVDR introduces a new risk-based classification system (Classes A–D) that has resulted in many IVDs being up-classified, triggering Notified Body involvement for the first time. For manufacturers with legacy devices, this change has significant implications for timelines, data requirements, and resource planning.
MD Compliance supports clients in confirming IVDR classification under the IVDR based on intended purpose, claims, and clinical context, including borderline and complex cases. We develop pragmatic transition strategies for legacy IVDs, taking into account transitional provisions, certificate validity, and Notified Body capacity constraints. Our approach helps manufacturers prioritise devices, plan submissions realistically, and align IVDR transition activities with broader business and portfolio strategies.
Under the IVDR, technical documentation requirements for IVDs have expanded significantly in both scope and detail. Manufacturers must demonstrate scientific validity, analytical performance, and clinical performance through a structured, traceable evidence framework, supported by robust post-market systems.
MD Compliance supports clients with the development, remediation, and review of IVDR-compliant technical documentation across all IVD classes. This includes gap assessments against IVDR Annex II and III requirements, authoring and updating technical files, and ensuring consistency across performance evaluation, risk management, labelling, and post-market documentation. Our focus is on producing clear, defensible documentation aligned with current IVDR guidance and Notified Body expectations, reducing the risk of delays or non-conformities during assessment.
Performance evaluation is a central pillar of IVDR compliance, integrating scientific validity, analytical performance, and clinical performance into a continuous lifecycle process. The IVDR places increased emphasis on the quality, relevance, and ongoing maintenance of performance data, particularly for higher-risk IVDs.
MD Compliance supports clients in developing IVDR-compliant Performance Evaluation Plans (PEPs) that define clear objectives, methodologies, and data sources. We assist in identifying and appraising relevant data, including analytical studies, clinical performance studies, literature, and post-market evidence. Where gaps exist, we help define appropriate performance evaluation strategies and post-market activities.
We also provide end-to-end support for the preparation and update of Performance Evaluation Reports (PERs). This includes remediation of legacy documentation developed under the IVDD, integration of new performance data, and alignment with intended purpose and device claims. Our PERs are structured to meet Annex XIII requirements and written with Notified Body review firmly in mind.
The IVDR introduces new transparency requirements through the Summary of Safety and Performance (SSP) for certain classes of IVDs. The SSP is intended to provide clear, publicly accessible information on device performance, safety, and clinical evidence for users and other stakeholders.
MD Compliance supports manufacturers in determining whether an SSP is required and in developing SSPs that are accurate, accessible, and fully aligned with underlying technical documentation. We ensure consistency between the SSP, performance evaluation conclusions, risk management, and labelling, helping reduce regulatory risk while meeting transparency obligations. Our approach balances regulatory compliance with clear communication, ensuring SSPs support user understanding without overstating performance or claims.
