MEDICAL DEVICES
IVDR transition timeline.
As these strands intertwine, review timelines inevitably lengthen. With the 2026 deadlines approaching, the pressure to submit a technically robust dossier intensifies.
Need for early, structured preparation Notified body capacity under the IVDR remains constrained, with organisations continuing to expand their resources, designation scopes, and operational processes while simultaneously managing significant Medical Devices Regulation (MDR) workloads. The MDR transition showed what happens when limited capacity meets immature submissions: incomplete dossiers, long rounds of questions, and multi-year delays in market access. Without early, disciplined preparation, the IVDR is on track to follow the same trajectory. A credible certification plan needs
to anchor itself to the legal deadline and work backward, building in time for internal quality checks, multiple review cycles, and the inevitable rounds of notified body queries and revisions. Manufacturers who act now will be beter positioned to meet the upcoming deadlines, avoid capacity driven delays, and maintain their device on the EU market.
Certify with BSI BSI holds a leadership position among EU designated notified bodies for IVDR Class C. Early engagement with BSI in 2026 yields three decisive benefits: Predictability: experienced reviewers identify gaps early, compressing the overall review cycle Proactive communication: through BSI Structured Dialogue, transparent, early discussion prevents the cascade of deficiency notices that derail late entrants Technical depth: multidisciplinary expertise – including clinical experts, risk management and post market surveillance specialists – ensures your evidence package aligns with IVDR requirements.
This level of regulatory clarity strengthens confidence across stakeholders, from investors to hospital networks and procurement teams, by demonstrating control, readiness and continuity.
Roadmap for early engagement 1. Begin with an internal audit. Mapping every GSPR against your current documentation, identifying gaps in performance evaluation, PMPF planning, or risk analysis.
2. Structure your dossier with clear, modular sections. Device description, intended use, analytical and clinical performance, risk management, and post market strategy.
3. Engage with a reputable notified body. Start with a pre-application meeting to outline your device, development status, and anticipate challenges.
4. Request BSI Structured Dialogue. This aligns expectations and understanding of the certification process and timeline.
5. Adopt a ‘no surprises’ mindset. Throughout the review process, use BSI’s notified body’s queries to refine alignment and maintain momentum.
With these steps embedded, the IVDR transition becomes a managed predictable pathway rather than a source of uncertainty.
This level of regulatory clarity strengthens confidence across stakeholders, from investors
to hospital networks and procurement teams, by demonstrating control, readiness and continuity
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WWW.PATHOLOGYINPRACTICE.COM April 2026
Public scrutiny reinforces regulatory responsibility Public scrutiny of medical device oversight has intensified, driven in part by high profile examinations of regulatory failure. The Bleeding Edge (Netflix, 2018), a documentary on safety failures in the US medical device industry, exposed systemic weaknesses: rushed approvals, limited clinical evidence, inadequate post market surveillance and poor transparency in safety reporting. These are exactly the structural gaps the IVDR seeks to close. Its core message resonates with today’s Class C IVD landscape: patient safety depends on robust, continuously reassessed, clinically anchored evidence. The lesson is clear. Proactive evidence
generation and early dialogue with an experienced notified body are now essential.
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