Medical Device & IVD Blog

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.

Comprehensive guide to the FDA eSTAR electronic submission template for 510(k) and De Novo submissions — mandatory requirements since October 2023, template structure, section-by-section walkthrough, completeness verification, submission methods, and common mistakes to avoid.

Comprehensive guide to FDA export certificates for medical devices — Certificate to Foreign Government (CFG), Certificate of Exportability (COE), CECATS application process, fees, eligibility criteria, common mistakes, and step-by-step instructions for global market access.

How to prepare for FDA medical device inspections under the new QMSR framework (CP 7382.850) — inspection types, the six QMS areas, common 483 observations, and a step-by-step readiness checklist.

How to develop and implement a Predetermined Change Control Plan (PCCP) for AI-enabled medical devices under FDA's August 2025 final guidance — three mandatory components, submission strategy, real-world examples, and step-by-step implementation roadmap.

How to prepare for FDA medical device inspections under the new Compliance Program CP 7382.850 — six QMS areas, four OAFRs, risk-based inspection methodology, ISO 13485 alignment, and step-by-step readiness checklist.

Understand the difference between GMP and cGMP for medical device manufacturing. Covers FDA QMSR (effective Feb 2026), 21 CFR Part 820, ISO 13485:2016 harmonization, cGMP requirements for design controls, production, packaging, labeling, and FDA inspection readiness.

Comprehensive guide to the FDA Humanitarian Device Exemption (HDE) pathway for rare disease medical devices — HUD designation process, HDE application requirements, probable benefit standard, profit restrictions, IRB oversight, post-approval obligations, QMSR implications, and step-by-step instructions.

How to validate and implement vaporized hydrogen peroxide (VHP) sterilization under ISO 22441:2022 — FDA Established Category A recognition, process parameters, validation protocol, material compatibility, and regulatory pathway for medical device manufacturers.

A comprehensive guide to IEC 60601-1-2 EMC compliance for medical electrical equipment — emissions and immunity requirements, Edition 4.1 changes, risk management integration, test plans, environment classification, and regulatory submission.

A comprehensive guide to IEC 82304-1 health software product safety — how it complements IEC 62304, product requirements, validation, cybersecurity, lifecycle management, regulatory alignment with FDA/EU MDR, and practical implementation for SaMD and health app manufacturers.

A comprehensive guide to radiation sterilization under ISO 11137 — gamma irradiation, electron beam, and X-ray methods, dose establishment methods (VDmax, Method 1, Method 2), materials compatibility, the 2025 standard update, validation workflow, and quarterly dose audits.