MedDeviceGuide — IVD & Medical Device Knowledge Base
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.
Boston Scientific-MiRus $1.5B TAVR Investment: SIEGEL Valve Strategy
Analysis of Boston Scientific's $1.5B MiRus investment, the SIEGEL balloon-expandable TAVR system, STAR pivotal trial, rhenium alloy technology, and structural heart market implications.
CMS NTAP Repeal for Breakthrough Devices: FY 2027 IPPS Impact
Guide to CMS's proposed repeal of the NTAP alternative pathway, the new RAPID coverage program, commercialization impact, and next steps for device makers.
FDA Leadership Crisis 2026: Medical Device Regulatory Impact
Analysis of FDA Commissioner Marty Makary's reported May 2026 resignation, leadership departures, workforce losses, device review timeline risks, and manufacturer planning steps.
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.
FDA Section 506J Device Shortage Reporting Guide
Understand Section 506J medical device shortage reporting, including mandatory notifications, the 506J list, OSCR oversight, and supply chain planning.
Ecuador ARCSA Medical Device Registration Guide: 2026 Requirements
Guide to Ecuador ARCSA registration for medical devices and IVDs under the April 2026 rules, covering classification, documentation, fees, timelines, and post-market obligations.
FDA READI-Home Innovation Challenge: Participation Guide
How medical device companies can join FDA's 2026 READI-Home challenge, including eligibility, phases, Q-submissions, and early engagement benefits.
Jordan JFDA Medical Device Registration: Requirements, Process and Timeline
Guide to registering medical devices and IVDs with Jordan's JFDA, covering classification, documentation, process steps, fees, timelines, authorized representatives, and post-market obligations.
CIRCIA for Medical Device Manufacturers: Cyber Incident Reporting to CISA
Prepare for CIRCIA cyber incident reporting rules, including 72-hour CISA reports, 24-hour ransomware payment notices, FDA overlap, coverage, and readiness steps.
FDA Weight Loss Device Guidance 2026: Premarket Evidence Guide
Review FDA's 2026 weight loss device guidance, including clinical study design, benefit-risk analysis, nonclinical testing, and obesity device strategy.
UK MHRA 2026 Overhaul: CE Mark Recognition, DORS Fees and Clinical Trials
Overview of MHRA's 2026 device reforms, including CE mark recognition, DORS fees, clinical trial changes and manufacturer compliance steps for Great Britain.
ASC Expansion 2026: CMS Final Rule and Medtech Commercial Strategy
How the CMS CY 2026 OPPS/ASC Final Rule adds 573 procedures, phases out inpatient-only limits, expands device payment opportunities, and reshapes medtech commercialization.
Health Canada MLMD Guidance 2026: PCCP, Bias, and AI Lifecycle
Guide to Health Canada's 2026 MLMD guidance for AI/ML devices, including PCCPs, data quality, bias controls, lifecycle risk, digital submissions, and FDA/EU comparisons.
Single-Use Device Reprocessing and Medtech Sustainability Guide
Assess single-use device reprocessing, circular economy benefits, hospital savings, carbon reduction, AMDR data, lifecycle evidence, EU MDR controls, and business case.
EU MDR Technical File Deficiencies: Common NB Nonconformities
Guide to common EU MDR technical file deficiencies in Notified Body review, including clinical evidence gaps, risk management, PMS links, equivalence, and 2026/977 timelines.
FDA Medical Device Warning Letter Trends 2024-2026: Enforcement Analysis
Data-driven analysis of FDA medical device warning letter trends from 2024 to 2026, including common violations, QMSR shifts, notable actions, and compliance lessons.
Medical Device Clinical Trial Diversity: FDA Action Plan Guide
How device sponsors can prepare FDA Diversity Action Plans under FDORA, set enrollment goals, address waiver criteria, and support representative clinical studies.