Labeling & UDI
41 articles
FDA Electronic Product Radiation Control (EPRC) for Medical Devices (21 CFR 1000-1050)
Guide to FDA Electronic Product Radiation Control (EPRC) under 21 CFR 1000-1050: 1002.1 matrix, Laser Notice 50/56, Form 2877, and Section 539 civil penalties.
FDA MRI Safety Labeling and GUDID Status: Data Analysis of 5.15M Device Records
Data analysis of 5.15 million FDA GUDID records evaluating MRI safety status distribution, ASTM F2503 labeling rules, implantable device coverage gaps, and 2023 guidance compliance.
EU MDR Article 22: Systems and Procedure Packs — Producer Obligations Guide
Complete guide to EU MDR Article 22 system and procedure pack producer obligations, the no-additional-CE-mark rule, Article 22(4) triggers, UDI, and the FDA convenience-kit comparison.
MDCG 2021-5 Rev.1 EU REP Symbol Transition Guide
A regulatory guide to the MDCG 2021-5 Rev.1 EU REP symbol transition, mapping OJEU decisions, Swiss and UK representative rules, and QMS timelines.
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.