European Union
280 articles
Adverse-Event Reporting Compared: FDA 21 CFR 803, EU MDR, Brazil, Thailand & SA
Side-by-side legal-text comparison of device adverse-event reporting: FDA 21 CFR 803, EU MDR Art. 87, Brazil RDC 67/2009, Thailand MoPH, SAHPRA — triggers, timelines, who must report.
Medical Device Economic Operator Duties Compared: EU MDR, NZ, Singapore, Canada, SFDA
Compare sponsor, importer, distributor and authorized-representative duties across EU MDR Articles 11-16, New Zealand WAND, Singapore HPA, Canada MDEL and Saudi SFDA MDS-REQ 9.
Recall vs FSCA Compared: FDA 21 CFR 806, EU MDR, Brazil & Thailand
Side-by-side legal-text comparison of medical device field actions: FDA 21 CFR Part 806, EU MDR FSCA/FSN, Brazil RDC 551/2021, and Thailand recall guidance — triggers, timelines, filing objects.
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.
EU AI Act for Medical Devices: August 2028 Deadline and MDR Dual Compliance Strategy
EU AI Act Omnibus extends medical device AI compliance to August 2, 2028. Dual MDR strategy, data governance, human oversight, tech doc integration, and preparation timeline.
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.
EU MDR Post-Market Surveillance Plan: MDCG 2025-10 Practical Guide
Build a PMS plan aligned with MDCG 2025-10 guidance: proactive data collection, QMS integration, trend reporting, PMS reports vs PSURs, and custom-made device obligations.
EU-Switzerland MRA Update 2026: What It Means for Medical Device Market Access
How the EU-Switzerland MRA signed March 2, 2026 restores medical device mutual recognition, what changes for EU and Swiss manufacturers, swissdamed timelines, and the path to ratification.
EUDAMED at Scale: 1.29 Million UDI-DIs Reveal Who Supplies the EU Device Market
Analysis of 1,292,737 EUDAMED UDI-DI records shows China leads with 19.1% of registrations, Turkey contributes 10.3% Class III devices, and four countries supply nearly half the EU market.
Medical Device Accessory Classification: EU MDR and FDA Pathways
How accessories are classified separately from parent devices under EU MDR Article 2(2) and FDA 513(f)(6), with examples, MDCG 2021-24 Rev.1 updates, and FDA's 2025-2026 reclassification initiative.
Aesthetic Device Regulation: FDA 510(k) and EU MDR for Laser, RF, and Energy Devices
How energy-based aesthetic devices — laser, RF, HIFU, IPL, cryolipolysis, and EMS — are classified and cleared by FDA and EU MDR, including special controls, Annex XVI, and 2026 compliance updates.
IVD Calibrator Traceability: ISO 17511, EU IVDR, and JCTLM Guide
Metrological traceability for IVD calibrators and control materials under ISO 17511:2020 and EU IVDR Annex I Section 9.3, covering calibration hierarchies, JCTLM resources, and common pitfalls.
21 CFR Part 4: Combination Product cGMP Quality Systems for Drug-Device Manufacturers
How drug-device combination product manufacturers implement quality systems under 21 CFR Part 4 — streamlined approach, QMSR update, design controls, stability, and EU MDR Article 117.
Medical Device Post-Approval Change Management: FDA, EU MDR, and Asian Markets (2026)
When device modifications require new regulatory submissions in the US, EU, Korea, Japan, and China — FDA special 510(k), PMA supplements, EU MDR significant changes, and Asian pathways.
Veterinary Medical Device Regulation: FDA CVM, EU Gaps, and Global Strategy
How veterinary medical devices are regulated under FDA CVM, EU frameworks, and key global markets. Covers classification gaps, 510(k) exemptions, off-label use, and market entry strategy.
EU AI Act High-Risk Classification Guidelines for Medical Device Manufacturers
EU Commission's May 2026 draft Article 6 high-risk AI classification guidelines: two-path system for medical devices, consultation deadline June 23, and compliance deadlines in 2027-2028.
Medical Device Cybersecurity Is Now a Procurement Gate: 2026 Hospital Buying Data
RunSafe's 2026 Index: 56% of hospitals reject devices over cybersecurity, 35% won't buy without an SBOM, and 84% include security in RFPs. What manufacturers must do now.
Medical Device Software Verification vs Validation: FDA and IEC 62304 Requirements
Software verification vs validation for medical devices — FDA expectations, IEC 62304 activities, documentation, traceability, and the design control process.
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.
eDHR for Medical Devices: QMSR, Part 11 & Digital Manufacturing (2026)
eDHR implementation guide for medical device manufacturers: QMSR requirements, 21 CFR Part 11, MES integration, ISO 13485, paper-to-digital migration, and inspection readiness.