Labeling & UDI
37 articles
RUO vs IUO vs IVD Labeling: Research, Investigational, and Diagnostic Boundaries
Practical guide to RUO, IUO, and IVD labeling boundaries, covering intended use, FDA guidance, diagnostic-use triggers, marketing risk, and classification decisions.
Colombia Medical Device Registration Cost 2026: INVIMA Rep Pricing Guide
Buyer-side guide to Colombia Representative pricing models, comparing hourly, annual, and flat-fee registration costs with 3-year cash flow examples.
eIFU for Medical Devices: EU MDR, FDA Rules, QR Codes, and Paper IFUs
Guide to electronic IFU rules for medical devices, covering EU Regulation 2025/1234, FDA 21 CFR Part 801, website access, QR codes, paper fallback, IVDR, SaMD, and validation.
Mexico Medical Device Registration Cost: MRH Pricing Guide (2026)
Compare Mexico MRH pricing models for medical device registration, including flat fees, hourly billing, three-year cash flow scenarios, switching steps, RFP points, and COFEPRIS pathways.
Switzerland Swissmedic Medical Device Registration Guide (2026)
How to register medical devices in Switzerland under Swissmedic: CH-REP duties, MedDO/IvDO rules, swissdamed deadlines, CE reliance, fees, and PMS obligations.
Batch Records for Medical Devices: BMR, EBR, DHR, and FDA QMSR
Guide to batch manufacturing records, electronic batch records, and DHRs for medical devices, covering 21 CFR 210/211, FDA QMSR, ISO 13485, review workflows, deviations, and inspection readiness.
FDA Emergency Use Authorization for Medical Devices: Regulatory Pathway
FDA EUA guide for medical devices covering Section 564 authority, CBRN emergency triggers, submission criteria, EUA vs 510(k)/PMA, termination, and active EUAs.
EU Declaration of Conformity for Medical Devices: 2026 Template Guide
How to draft an EU MDR Declaration of Conformity under Article 19 and Annex IV, including required content, language rules, legacy devices, and templates.
FDA Medical Device Advertising and Promotion Compliance Guide (2026)
Guide to FDA medical device advertising and promotion compliance, including 21 CFR Part 801, OPEQ enforcement, off-label claims, social media, FTC oversight, and warning letters.
ISO 15223-1 Medical Device Symbols: Complete Labeling and Marking Guide (2026)
Guide to ISO 15223-1 medical device symbols and labeling, covering the 2025 EU REP amendment, MDR/IVDR requirements, symbol validation, categories, and implementation.
Arabic Labeling, UDI & Halal Certification for Medical Devices in MENA (2026)
MENA medical device labeling guide covering Arabic language rules, UDI requirements, halal certification, and country expectations for Saudi Arabia, UAE, Egypt, Israel, Turkey, and Qatar.
Borderline Product Classification Across FDA, EU MDR, ANVISA, and COFEPRIS
How to classify hand sanitizer, mouthwash, personal lubricants, and data recorders as medical devices or non-devices across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS.
EUDAMED Day Zero Playbook: Role-Specific Actions Before May 28, 2026
Role-by-role playbook for the May 28, 2026 EUDAMED deadline, covering actor registration, UDI/device data, certificates, surveillance duties, and final readiness steps.
QMSR Gap Analysis for ISO 13485 Companies: 50+ Item Checklist
Use this QMSR gap analysis checklist to map ISO 13485:2016 processes to FDA requirements for terminology, complaints, labeling, UDI, records, and action items.
Colombia INVIMA Medical Device Registration Guide for Foreign Manufacturers (2026)
Guide to INVIMA medical device registration in Colombia, including classification, controlled and uncontrolled pathways, UDI-DI, fees, legal representation, and PMS.
EUDAMED Registration Guide for Medical Device and IVD Manufacturers
Step-by-step EUDAMED registration guide covering SRN actor registration, UDI/device data, Notified Body certificates, market surveillance, May 2026 deadlines, and legacy devices.
Medical Device Labeling & UDI System: The Complete Regulatory Guide
Understand FDA and EU MDR labeling requirements, UDI system setup, GUDID submissions, global UDI harmonization, compliance checklists, and common pitfalls.