EU MDR / IVDR
113 articles
IVD Registration Compared: FDA 809, EU IVDR, China, Brazil & India
Side-by-side legal-text comparison of IVD registration: FDA 21 CFR Part 809, EU IVDR 2017/746, China SAMR Decree 48, Brazil RDC 830/2023, India MDR 2017 — classes, pathways, who reviews.
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.
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.
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.
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.
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.
RPM Device Regulatory Pathway: FDA, CMS Reimbursement & EU MDR (2026)
RPM device regulation: FDA classification, CMS 2026 CPT codes (99445, 99470), reimbursement rates, SaMD, EU MDR pathway, and commercialization strategy for connected monitoring devices.
EU Digital Product Passport for Medical Devices: ESPR, Batteries, and UDI
Guide to EU Digital Product Passport requirements for medical devices, including ESPR scope, battery passports, UDI/EUDAMED links, standards, and timelines.
Liquid Biopsy and Multi-Cancer Early Detection (MCED) Tests: FDA, IVDR Regulatory Pathway
Regulatory guide to liquid biopsy and MCED tests, including FDA pathways, Breakthrough designation, companion diagnostics, EU IVDR classification, clinical evidence, and key market players.
Swissmedic 2026 PMS Focus Campaign: What Class IIa/IIb/III Manufacturers Must Prepare Now
Swissmedic 2026 PMS focus campaign guide for Class IIa, IIb, and III devices, covering PMS plans, PSURs, PMCF data, complaints, trend analysis, and preparation.
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.
EU MDR Article 10a: Supply Chain Discontinuation and Shortage Prevention
Learn when manufacturers must report device interruptions under EU MDR Article 10a, who to notify, required data, supply chain flow, and 2026 guidance.
EU MIR Form 7.3.1 Mandatory Update: What Changed From Version 7.2.1 and How to Prepare
Prepare for EU MIR Form 7.3.1, mandatory from May 1, 2026, including changes from 7.2.1, reportability fields, UDI issuing entity selection, EUDAMED XML, and vigilance updates.
EU MDR Article 59 National Derogation: CE Marking Exemptions
Practical guide to MDR Article 59 national derogations, including when non-CE-marked devices may be authorized, how reviews work, and manufacturer strategy.
EU Reference Laboratories for IVDR Class D IVDs: EURL Guide
Guide to EU Reference Laboratories under IVDR Article 100 for Class D IVDs, including rollout, affected categories, performance verification, batch testing, and manufacturer preparation.