Labeling & UDI
37 articles
Swissdamed Registry Analysis: 4,554 Swiss Actors and 60,611 Device Registrations
A data-driven analysis of Swissmedic's swissdamed database. We break down actor types, risk classes, legislations, and leading CH-REPs.
Medical Device Accessibility: ADA, Section 508, and EU Accessibility Act Guide
ADA Title II/III, Section 508, WCAG 2.1 AA, and the EU Accessibility Act applied to medical devices, SaMD, patient apps, and infusion-pump screens — what it means for device design.
UDI & Labeling Compared: FDA 801/830, EU MDR, Mexico NOM-137 & China
Legal-text comparison of medical device UDI and labeling: FDA 21 CFR Parts 801 & 830, EU MDR Article 27/Annex VI, Mexico NOM-137-SSA1-2025, and China Order 6/2014 — carriers, databases, and language.
510(k)-Exempt in 2026: How to Check the QMSR, Registration, and UDI Duties You Owe
A 510(k) exemption removes one filing, not your compliance program. How to confirm exempt status and the QMSR, registration, and UDI duties that survive.
GUDID Data-Quality Checklist: What Distributors Should Verify Before a Contract
A portfolio GUDID data-quality checklist for distributors — check labeler completeness, missing descriptions, and identifier integrity per contract.
How to Verify a Medical Device UDI: A GUDID Lookup Workflow for Hospital Purchasing
How to look up and verify a medical device's UDI in FDA AccessGUDID before purchasing, what the DI fields mean, and the data-quality gaps that break a lookup.
EUDAMED After Go-Live: What the First Weeks Reveal and What to Do Next
Post-May 28 EUDAMED compliance reality check: common registration errors, data consistency traps, legacy device triage, NB certificate bottlenecks, and a six-month action plan.
Dermal Fillers vs Cosmetics vs Medicines: Hong Kong Borderline Classification After GN-00
How Hong Kong classifies injectable dermal fillers at the borderline between medical devices, cosmetics, and medicines — and why the May 2026 GN-00 update matters for your product.
Hong Kong MDACS GN-00 Update: Why Injectable Dermal Fillers Are Now Medical Devices
On 13 May 2026, Hong Kong MDD updated GN-00 to classify injectable dermal fillers as medical devices under MDACS. What changed, why it matters, and what manufacturers must do.
EUDAMED Mandatory Registration: May 28, 2026 Deadlines and UDI Steps
Guide to mandatory EUDAMED registration from May 28, 2026, including actor registration, UDI/device data, certificate linkage, legacy device deadlines, and action steps.
EUDAMED Bulk Upload Validation Error Playbook: Fix XML Rejections
Playbook for diagnosing EUDAMED bulk upload validation errors, including XSD failures, UDI mismatches, EMDN issues, certificate links, DTX codes, and pre-upload checks.
Home-Use IVD Invalid Result Workflow for Consumer Diagnostics
Design and monitor invalid-result workflows for home-use IVDs, including invalid rates, lay-user errors, repeat testing, IFU comprehension, support scripts, and postmarket trending.
RUO-to-IVD Conversion Firewall: Convert Research-Use Assays Without Evidence Risk
Operational guide to converting RUO assays into regulated IVDs, covering claims cleanup, distributor controls, data triage, validation bridging, training, and evidence firewalls.
Global UDI Compliance Deadlines 2026 by Country
Track 2026 UDI compliance deadlines across the EU, Switzerland, Australia, China, Brazil, Singapore, and the US, with class rules and data requirements.
Swissdamed Mandatory July 2026: Swiss Device Registration and UDI Guide
Guide to Switzerland swissdamed mandatory registration from July 1, 2026, covering UDI uploads, Product Module, CH REP duties, M2M, grace periods, and triggers.
Direct-to-Consumer Genetic Tests: FDA, FTC, Privacy, Clinical Validity, and Claims Control
Guide to regulatory, privacy, and commercial risks for DTC genetic tests, including FDA oversight, FTC claim substantiation, clinical validity, GINA, state privacy laws, and risk-report claims.
EUDAMED Registration Mistakes: 10 Errors to Fix Before May 28, 2026
Learn the 10 most common EUDAMED registration mistakes before the May 28, 2026 mandate, including data, UDI, actor, certificate, and workflow errors, plus fixes.
Home-Use and Self-Test IVDs: Pathways, Human Factors, and Labeling
Regulatory guide for home-use and self-test IVDs, covering FDA OTC and CLIA pathways, EU IVDR self-testing, human factors, labeling, specimen errors, and PMS.
ISO 17664 Reprocessing Validation for Reusable Medical Devices
Guide to ISO 17664 reprocessing validation for reusable devices, covering cleaning, disinfection, sterilization, worst-case families, IFU content, FDA expectations, and submission evidence.
Medical Device IFU Reprocessing Instructions: Validated, Audit-Ready Guide
Step-by-step guide to writing validated reprocessing instructions for reusable device IFUs, covering cleaning, sterilization, usability, warnings, and audits.