Medical Device & IVD Blog

Complete guide to the GLP-1 drug-delivery device landscape in 2026 — auto-injector pens, oral delivery devices, combination product regulatory pathways, FDA and EU MDR requirements, and market outlook.

An analysis of the EU MDR and IVDR Notified Body capacity crisis using 2026 survey data — 33,175 MDR applications vs 17,549 certificates issued, 13–18 month review times, IVDR Class C deadline, and a practical action plan for manufacturers facing certification gaps.

A deep analysis of FDA's January 2025 draft guidance on AI-Enabled Device Software Functions — total product lifecycle approach, data management requirements, bias mitigation strategies, transparency expectations, marketing submission content, and practical steps manufacturers should take before the guidance is finalized.

A comprehensive guide to regulatory sandboxes for medical devices — MHRA AI Airlock (£3.6M expansion), FDA TEMPO pilot for digital health, EU sandbox proposals, and how manufacturers can participate in these programs to accelerate market access.

How the EU Corporate Sustainability Reporting Directive affects medical device manufacturers — scope, ESRS standards, double materiality, timelines, Omnibus simplification, and practical compliance steps for MedTech.

How to select, evaluate, and change Notified Bodies under EU MDR and IVDR — capacity constraints, selection criteria, transfer process, 2026 implementing regulation, and timeline planning.

How Good Clinical Practice applies to medical device clinical trials — navigating ISO 14155:2026 and ICH E6(R3), sponsor and investigator responsibilities, informed consent, safety reporting, and audit readiness.

An independent comparison of the top regulatory intelligence platforms for medical device and IVD manufacturers in 2026 — covering RegDesk, IQVIA, Cortellis, Obsidian, Basil Systems, ArisGlobal, Freyr RegIntel, and Veeva Vault Regulatory.

Protocol-level guide to cleaning validation for reusable surgical instruments — covering artificial soil selection, protein/hemoglobin/TOC endpoints, worst-case device families, manual vs automated cleaning, ANSI/AAMI ST98 acceptance criteria, sample size justification, and report structure.

Dedicated CLIA waiver playbook for IVD manufacturers — covering waived, moderate, and high complexity categories, CW submission content, flex studies, lay-user studies, the Dual 510(k) + CLIA Waiver pathway, review timelines, common deficiencies, and real-world examples.

Section-by-section CER template for EU MDR compliance — covering clinical evaluation plan, device description, literature search protocol, data appraisal tables, equivalence justification, benefit-risk analysis, PMCF linkage, evidence traceability matrix, and Notified Body-ready formatting. Free alternative to gated competitor templates.

Practical guide for building a coordinated vulnerability disclosure (CVD) program for medical devices — covering PSIRT setup, vulnerability intake and triage, CVSS scoring, SBOM linkage, field safety notices, FDA Section 524B requirements, EU expectations, and customer communication templates.

Practical guide to using digital twins, synthetic data, and computational modeling in medical device regulatory submissions — covering FDA CM&S credibility guidance, ASME V&V 40, in silico clinical trials, synthetic control arms, model validation pitfalls, and documentation strategies.

Regulatory, commercial, and privacy risk guide for direct-to-consumer (DTC) genetic testing companies — covering FDA oversight of DTC IVDs, wellness vs. medical claims boundaries, analytical and clinical validity requirements, risk report authorization, GINA and state privacy laws, FTC advertising substantiation, 23andMe bankruptcy data precedent, and practical guidance on claims that change regulatory status.

Downloadable GSPR checklist template for EU MDR Annex I compliance — covering all 23 requirements across three chapters, with columns for applicability assessment, evidence files, harmonised standards mapping, gap analysis, owner assignment, and remediation tracking. Practical alternative to gated competitor templates.

With EUDAMED becoming mandatory on May 28, 2026, manufacturers are discovering that registration is far more complex than a simple data upload. Here are the 10 most common mistakes — and exactly how to avoid each one.

Practical regulatory guide for home-use and self-test in vitro diagnostic devices — covering FDA pathways (OTC, prescription home use, CLIA waiver), EU IVDR self-testing requirements, human factors and lay-user usability, specimen collection errors, labeling requirements, DTC vs provider-ordered models, and post-market surveillance for consumer diagnostics.

Manufacturer-facing guide to reprocessing validation for reusable medical devices under ISO 17664-1, ISO 17664-2, FDA guidance, and EU MDR — covering cleaning, disinfection, sterilization validation, worst-case device families, IFU content, and premarket submission evidence.

Protocol-level analytical validation guide for IVD manufacturers — covering test plan tables, acceptance criteria, sample selection, statistical methods per CLSI standards, and FDA/EU IVDR expectations for analytical performance evidence.

Complete guide to registering medical devices in Kenya through the Pharmacy and Poisons Board (PPB) in 2026 — including classification (Class A–D), evaluation routes (full, abridged, expedited, immediate), reliance pathways, local authorized representative requirements, import permits, QMS audits, post-market surveillance, and step-by-step registration instructions.