Medical Device & IVD Blog

Regulatory and risk assessment guide for medical devices incorporating nanomaterials — covering EU MDR Rule 19 classification, FDA nanotechnology guidance, ISO 10993-22 biocompatibility, SCENIHR exposure framework, nanotoxicology testing, sterilization challenges, labeling requirements, and a decision tree for regulatory strategy.

Comprehensive regulatory and validation strategy for next-generation sequencing (NGS) in vitro diagnostic devices — covering FDA pathways (510(k), De Novo, PMA), proposed CDx reclassification, EU IVDR classification, wet lab and bioinformatics pipeline validation, variant calling, reference databases, clinical validity, cybersecurity, and post-market obligations.

Practical PMCF Plan template aligned with MDCG 2020-7 and EU MDR Annex XIV Part B — covering objectives derivation from CER gaps, method selection (registries, surveys, studies, literature), endpoint definition, sample size logic, schedule, triggers, PMCF evaluation report structure, and PMS integration.

Japan's PMDA made eCTD v4.0 mandatory on April 1, 2026. This guide covers what changed, Japan-specific Module 1 requirements, medical device submission differences, and how to prepare compliant submissions.

Comprehensive regulatory strategy guide for pre-filled syringes and auto-injectors as drug-device combination products — covering FDA OCP/RFD jurisdiction, ISO 11608 design verification, human factors validation, EU MDR Article 117, QMSR quality system implications, stability testing, and lifecycle change management.

Step-by-step guide to writing reprocessing instructions for reusable medical device IFUs — covering point-of-use treatment, cleaning, disinfection, sterilization, drying, storage, reuse life claims, warnings, usability validation, and audit readiness per FDA guidance, ISO 17664, and ISO 20417.

Regulatory strategy guide for surgical robot manufacturers — covering FDA classification (510(k), De Novo, PMA), autonomy levels, software controls (IEC 62304), electrical safety (IEC 60601), usability (IEC 62366), clinical evidence expectations, EU MDR requirements, training programs, and post-market surveillance.

Practical labeling and intended-use boundary guide for IVD manufacturers — covering FDA RUO/IUO guidance, clinical diagnostic use triggers, enforcement actions, marketing language risk, distributor behavior, and a decision tree for regulatory classification.

Comprehensive supplier audit checklist for medical device manufacturers — covering supplier risk classification, qualification, audit agenda, purchasing controls per ISO 13485 Clause 7.4 and FDA QMSR, quality agreements, outsourced sterilization/testing/software, CAPA follow-up, and evidence records.

Equipment and process validation guide for washer-disinfectors in medical device reprocessing — covering ISO 15883 series parts 1–7, IQ/OQ/PQ methodology, A₀ value concept, load configurations, chemical dosing, temperature monitoring, microbiological endpoints, maintenance, and deviation handling.

On March 20, 2026, the European Commission adopted two delegated regulations expanding the Well-Established Technology (WET) list under EU MDR. C(2026) 1798 exempts additional implantable and Class III devices from clinical investigations. C(2026) 1809 simplifies conformity assessment for Class IIb implantable devices. This guide covers what changed, which devices qualify, WET criteria, and practical steps for manufacturers.

Health Canada's 2026 regulatory reforms introduce expanded Terms & Conditions (T&C) powers for Class II–IV devices, new AI/ML-enabled medical device guidance, mandatory Regulatory Enrolment Process (REP), IMDRF Table of Contents requirements, and updated significant change guidance. This guide covers every major change effective January–April 2026 and what foreign manufacturers must do to maintain Canadian market access.

FDA's February 2026 cybersecurity guidance and Section 524B of the FD&C Act make penetration testing, vulnerability scanning, and fuzz testing mandatory evidence for connected medical device submissions. This guide covers what testing is required, how to structure results, common FDA deficiencies, EU MDR cybersecurity expectations, and how to build a testing program that satisfies both regulatory frameworks.

On April 23, 2026, CMS and FDA announced the RAPID pathway — a new initiative that could deliver Medicare national coverage within 60–90 days of FDA authorization for eligible Breakthrough Devices. This guide explains eligibility requirements, how the pathway works, IDE study design implications, and what manufacturers must do to prepare.

On February 3, 2026, the FDA reissued its premarket cybersecurity guidance aligned with the new Quality Management System Regulation (QMSR) and ISO 13485:2016. This guide covers what changed, what stayed the same, how to map cybersecurity to ISO 13485 clauses, and practical steps for manufacturers building connected devices in 2026.

On January 6, 2026, the FDA significantly expanded its General Wellness policy, now allowing certain wearable devices that estimate blood pressure, blood glucose, oxygen saturation, and other physiologic parameters to qualify as non-regulated wellness products. This guide covers the new criteria, FDA's illustrative examples, the line between wellness and medical device claims, and what manufacturers must do to stay compliant.

Data-driven analysis of medical device recall trends through 2024–2026 — 1,059 recall events, Class I recalls at a 15-year high, device failure as the new #1 cause, ~440 million units affected (up 55%), software defect trends, FDA early alert pilot, and risk mitigation strategies for manufacturers.

Complete guide to third-party vendor cybersecurity risk management for medical devices — FDA Section 524B, QMSR ISO 13485 alignment, SBOM requirements, vendor risk assessment frameworks, MITRE threat modeling, and implementation strategies for connected device manufacturers.

Complete guide to the RAPS Regulatory Affairs Certification (RAC) in 2026 — RAC-Devices vs RAC-Drugs, eligibility requirements, exam content, 2026 testing windows, study strategies, preparation resources, and how RAC certification advances your regulatory affairs career.

Complete guide to augmented reality and virtual reality medical device regulation — FDA classification, product codes, 510(k) vs De Novo pathways, the 104 FDA-cleared AR/VR devices, surgical navigation, therapeutic VR, and human factors requirements in 2026.