MedDeviceGuide — IVD & Medical Device Knowledge Base

How wearable medical devices are regulated in the US and EU — FDA 2026 general wellness guidance, wellness vs. medical device classification, 510(k) and De Novo pathways for smartwatches and CGMs, EU MDR classification, market size data, key cleared devices, and compliance strategy for manufacturers.

Master batch manufacturing records (BMR), electronic batch records (EBR), and device history records (DHR) for medical device manufacturing. Covers 21 CFR 210/211, 21 CFR Part 820/QMSR, ISO 13485, paper vs electronic systems, review workflows, deviation management, and FDA inspection readiness.

How to perform bioburden testing for medical devices under ISO 11737-1:2018 — method validation, recovery efficiency, extraction techniques, enumeration methods, dose setting, and routine monitoring for sterilization validation.

How to classify, design, validate, and monitor cleanrooms for medical device manufacturing under ISO 14644 — particle count limits, classification methodology, environmental monitoring programs, FDA and EU GMP requirements, and the 2025 update to ISO 14644-5.

How to calculate and reduce Cost of Quality in medical device manufacturing using the four-category model. Includes the 1-10-100 rule, McKinsey industry benchmarks (6.8–9.4% of sales), eQMS ROI data, and step-by-step implementation aligned with ISO 13485 and FDA QMSR.

How to transition from Computer System Validation (CSV) to Computer Software Assurance (CSA) under FDA's September 2025 final guidance — risk-based approach, testing strategies, documentation requirements, and step-by-step implementation roadmap.

Comprehensive guide to the FDA Emergency Use Authorization (EUA) pathway for medical devices under Section 564 of the FD&C Act — legal basis, CBRN emergency triggers, statutory criteria, submission process, EUA vs 510(k)/PMA comparison, post-COVID transition framework, and current active EUAs.

How to manage Engineering Change Orders (ECOs) in medical device manufacturing — ECR to ECO to ECN workflow, ISO 13485 Clause 7.3.9 requirements, FDA QMSR design change control, risk assessment, regulatory notification triggers, and best practices for cross-functional approval.

How to build and manage an equipment calibration program for medical device manufacturing — ISO 13485 Clause 7.6 requirements, FDA QMSR compliance, NIST traceability, ISO 17025 accreditation, calibration schedules, out-of-tolerance procedures, and electronic calibration management.

Complete guide to how the EU Cyber Resilience Act (CRA) and NIS2 Directive affect medical device manufacturers — including the MDR/IVDR exemption, indirect CRA impact scenarios, NIS2 supply chain obligations, MDCG cybersecurity guidance, timelines, penalties, and compliance strategies.

Deep walkthrough of all 22 EU MDR classification rules in Annex VIII — non-invasive, invasive, active, and special rules — with MDD-to-MDR changes, software and nanomaterial up-classification, MDCG 2021-24 guidance, and practical strategies for correct device classification.

Everything manufacturers need to know about EU MDR Common Specifications — Article 9 legal basis, Annex XVI products without medical purpose, Implementing Regulation (EU) 2022/2346, reclassification under (EU) 2022/2347, Class D IVD common specifications, presumption of conformity, and transitional timelines through 2028.

How to draft a fully compliant EU Declaration of Conformity under MDR Article 19 and Annex IV — content requirements, language obligations per Member State, legacy device considerations, digital DoC proposals for 2026, and a complete annotated template covering Class I through III devices.

How to demonstrate compliance with all 23 General Safety and Performance Requirements (GSPR) under EU MDR Annex I — chapter-by-chapter walkthrough, GSPR checklist template, harmonised standards mapping, cybersecurity and AI updates for 2026, and practical strategies for Notified Body submissions.

How harmonised standards work under EU MDR Article 8 — the complete 2026 list including Implementing Decision (EU) 2026/193, presumption of conformity mechanics, GSPR mapping methodology, the 17% harmonisation gap (48 of 277 standards), MDCG 2021-5 guidance, and practical compliance strategies for manufacturers facing the 79% regulatory grey zone.

Comprehensive guide to EU MDR importer and distributor obligations under Articles 13, 14, and 16 — including EUDAMED registration, labeling requirements, QMS obligations, verification checklists, and the MDCG 2021-27 Q&A guidance for economic operators.

Everything about the Person Responsible for Regulatory Compliance (PRRC) under EU MDR Article 15 — qualification pathways, responsibilities, small enterprise outsourcing rules, MDCG 2019-7 guidance, the 2025 simplification package removing rigid qualification thresholds, liability protections, EUDAMED registration, and practical implementation strategies.

Complete guide to FDA medical device advertising and promotion regulations — 21 CFR Part 801 labeling requirements, OPEQ enforcement, off-label promotion rules, social media compliance, FTC oversight, warning letters, and practical strategies for compliant promotional claims.

Complete guide to FDA's January 2026 Clinical Decision Support software guidance — the four statutory criteria for non-device CDS exclusion under Section 520(o)(1)(E), device vs non-device examples, SaMD boundary decisions, enforcement discretion positions, and practical compliance strategies for digital health companies.

Comprehensive guide to FDA medical device establishment registration and device listing under 21 CFR Part 807 — FURLS/DRLM system walkthrough, FY 2026 fees ($11,423), who must register, annual renewal process, common violations, and step-by-step instructions.