COMPLIANCE
evidence frameworks that withstand scrutiny, support clinical integration, and scale globally. At BSI, we support manufacturers in navigating this shift by providing structured, expert-led assessment that reflects regulatory expectations, clinical realities, and the shifting demands of global deployment. Across the industry, we are seeing a
transition: from static documentation to dynamic, post-market evidence ecosystems; from narrow performance claims to integrated usability and deployment data. The rise of AI-enabled diagnostics, decentralised testing, and equitable diagnostic access strategies demands new thinking – evidence must be relevant, inclusive, and iteratively refined.
The IVDR is a recalibration of
evidence expectations across the diagnostic landscape. As the field evolves, manufacturers and laboratories globally must navigate this space and build evidence strategies that are robust, future-ready and aligned with real-world clinical practice.
Engagements with healthcare systems, academic institutions, and pharmaceutical companies facilitate access to data, patient cohorts, and clinical expertise.
Adaptive and staged study designs. Staged evidence collection allows manufacturers to generate initial data for early conformity assessment, followed by expanded post-market studies. Adaptive designs enable flexibility in endpoints and sample sizes, building resilience into the process. Collaborative models. Engagements with healthcare systems, academic institutions, and pharmaceutical companies facilitate access to data, patient cohorts, and clinical expertise. These models support more robust and contextually relevant evidence, particularly for complex or high-risk technologies. These cross-sector partnerships strengthen regulatory alignment and support shared accountability. Responsible use of literature. Systematic reviews and meta-analyses can support scientific validity claims, provided the underlying studies are current, peer-reviewed, and methodologically vigorous. However, landmark studies, widely cited in clinical guidelines or reflecting real-world diagnostic practice, often carry greater weight. Transparency in selection criteria and limitations remains essential to maintain regulatory confidence. Instructions For Use updates.
Within the framework of MDCG 2022-2, IFU becomes a critical output of the performance evaluation process, reflecting the state of the art, the strength of comparator data, and the limitations of the evidence base. Updates to the IFU must ensure that performance claims remain consistent with the data used to establish equivalence, that limitations arising from gaps in comparator evidence are transparently communicated, and that users understand the conditions under which the claimed performance is valid. Where comparator data are incomplete, heterogeneous, or not fully aligned with the intended use, MDCG 2022-2 emphasises the need for manufacturers to clearly articulate these constraints within the IFU or to generate bridging evidence. In this context, the IFU is a key mechanism for ensuring that performance claims are credible, clinically relevant, and supported by all available evidence.
Summary: compliance to credibility As the IVDR continues to evolve, industry leaders must move beyond interpretation and reactive compliance to strategic implementation. As manufacturers adapt, the challenge is no longer simply meeting expectations outlined in MDCG 2022-2, but actively building
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References 1 Medical Device Coordination Group. MDCG
2022-2: Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices. (MDCG, 2022) htps://
health.ec.europa.eu/system/ files/2022-01/mdcg_2022-2_en.pdf
2
Infected Blood Inquiry. Infected Blood Inquiry: The Report (HC 569 III). (His Majesty’s Stationery Office, 2024)
www.infectedbloodinquiry.org.uk/reports
3 European Parliament, Council of the European Union. Regulation (EU) 2017/746 on in vitro diagnostic medical devices. (Off J Eur Union, 2017) htps://eur-lex.
europa.eu/eli/reg/2017/746/oj/eng
Lorna Ingoldsby is Internal Clinician IVD at BSI, a role she has held since December 2023. Prior to this, Lorna held senior management roles in both the private clinical laboratory and public hospital sectors. Lorna holds a BSc and PhD in Biochemistry and Molecular Biology from University College Dublin, an MSc in Biomedical Science from the University of Ulster and a Specialist Diploma in Lean Systems from the University of Limerick.
About BSI
As a Notified Body, BSI plays a key role in the conformity assessment process, working with manufacturers across a range of industries. Through independent and impartial assessment against applicable requirements, it enables manufacturers and laboratories to demonstrate compliance with IVDR. BSI offers structured product review services to support a predictable and efficient path to market.
www.bsigroup.com
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