European Union
280 articles
Sterilization Supplier Strategy for Medical Devices: Capacity and Dual Sourcing
Manage sterilization supplier capacity risk with EtO and cobalt-60 exposure, dual-source qualification, alternative modalities, quality agreements, and ISO 13485/QMSR planning.
Tubing and Extrusion Supplier Qualification for Medical Devices: From Audit to Validation
Qualify medical tubing and extrusion suppliers, from selection and audits to IQ/OQ/PQ validation, traceability, cleanroom controls, and ongoing monitoring.
J&J Atraverse Acquisition: Cardiac Ablation Access Technology and EP M&A
Analysis of J&J's April 24, 2026 Atraverse Medical acquisition, covering HOTWIRE transseptal access, RF guidewire technology, Biosense Webster strategy, and the cardiac ablation M&A landscape.
Stryker Acquires Amplitude Vascular Systems: IVL and Peripheral Vascular Strategy
Stryker's May 2026 AVS acquisition adds next-generation IVL for calcified PAD, including the CO2 pressure wave platform, regulatory path, competition, and market impact.
Bayer-Perfuse $2.45B Deal: Ophthalmology Drug-Device Strategy
Analysis of Bayer's up to $2.45B Perfuse Therapeutics acquisition, including the PER-001 intravitreal implant, deal terms, endothelin mechanism, and ophthalmic drug-device convergence.
GE HealthCare Restructuring, Price Hikes, and MedTech Supply Impact
What GE HealthCare's 2026 restructuring, leadership changes, price increases, and $250M inflation hit mean for medtech supply chains and device manufacturers.
Sun Pharma $11.75B Organon Acquisition: Women's Health and Biosimilars
Sun Pharma's $11.75B Organon deal reshapes women's health and biosimilars. Review deal structure, combination-product considerations, portfolio assets, and regulatory impact.
Danaher's $9.9B Masimo Acquisition: Patient Monitoring and Diagnostics Impact
Analysis of Danaher's $9.9B Masimo acquisition, including deal structure, strategic rationale, antitrust considerations, patient monitoring competition, and medtech industry impact.
EU Breakthrough Device (BtX) Designation: MDCG 2025-9 and EMA Pilot Guide
Guide to the EU BtX framework under MDCG 2025-9, covering eligibility, application steps, EMA pilot benefits, FDA comparisons, and IVD implications.
MedTech Europe MDR/IVDR 2.0 Position Paper: Proposed Changes
Analyze MedTech Europe's May 2026 MDR/IVDR position paper, including breakthrough and orphan pathways, cybersecurity, AI, IVDR concerns, and the legislative process.
EU AI Act Omnibus Amendment 2026: Medical Device Impact Guide
Explains the May 7, 2026 EU AI Act omnibus deal, product safety exemptions, revised timelines, and compliance actions for AI-enabled SaMD and IVDs.
EU Implementing Regulation 2026/977: Uniform Notified Body Requirements Under MDR and IVDR
Guide to Implementing Regulation (EU) 2026/977 for MDR and IVDR Notified Body assessments, including QMS rules, maximum timelines, clock stops, quotes, and recertification.
IVDR Class C Transition Deadline: What IVD Manufacturers Must Do Before May 26, 2026
Practical guide to the May 26, 2026 IVDR Class C deadline, covering Notified Body applications, the September 2026 agreement milestone, 2028 market access, and key pitfalls.
MDCG 2026 Updates: Classification, EMDN Codes, and Borderline Guidance
Practical guide to April 2026 MDCG updates on MDR/IVDR classification, EMDN v3/2026 codes, the Borderline Manual, and manufacturer compliance actions.
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.
NGS Bioinformatics Pipeline Change Control: Documentation and Revalidation Guide
Document NGS bioinformatics pipeline changes, assess validation impact, control software and database updates, and prepare IEC 62304 audit records for IVDs.
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.
GLP-1 Drug Delivery Devices: Combination Product Pathways 2026
Guide to the GLP-1 drug delivery device ecosystem, including auto-injector pens, oral delivery, combination product pathways, FDA, EU MDR, and market outlook.
EU MDR Notified Body Capacity Crisis 2026-2027: Manufacturer Action Plan
Analysis of EU MDR and IVDR Notified Body capacity using 2026 survey data, review timelines, certification bottlenecks, IVDR Class C risk, and manufacturer actions.
Medical Device Regulatory Sandboxes: MHRA AI Airlock and FDA TEMPO
Guide to medical device regulatory sandboxes, including MHRA AI Airlock, FDA TEMPO for digital health, EU proposals, eligibility, participation, and market access benefits.