European Union
305 articles
EU PFAS Restriction for Medical Devices: REACH Timelines and Derogations
How the EU REACH PFAS restriction affects medical device components, key transition timelines (5- and 12-year derogations), concentration limits, and substitution roadmaps.
SPC for Medical Devices: Cpk/Ppk Targets, Gauge R&R, and Process Validation
A quality engineering guide to statistical process control (SPC) and process capability (Cpk/Ppk) for medical device process validation, including Gauge R&R and FDA QMSR compliance.
Adaptive AI Medical Devices: Why an FDA PCCP Won't Update Your Model in the EU or Japan
A cross-market analysis of AI medical device change control, comparing the US FDA PCCP, Japan's IDATEN framework, and the EU's MDR and AI Act modification rules.
Why One FDA/CE Clearance Opens Far Fewer CGM Markets: The Global Class-Divergence Map
A comprehensive cross-market analysis of continuous glucose monitor (CGM) classification, clinical trial requirements, and reimbursement gates across the US, EU, China, Japan, and Canada.
EU Medical Device Procurement & TED Tenders by the Numbers (2026)
A deep quantitative teardown of EU public medical device tenders on Tenders Electronic Daily (TED). Analysis of CPV 331 notice trends, country concentrations, contract values, and top suppliers.
EUDAMED Actors by the Numbers: 48,071 Manufacturers, Importers, and ARs (2026)
A deep quantitative teardown of the EUDAMED Actor module. Analysis of role distribution, country concentration, non-EU manufacturer dependencies, and EU Authorised Representative capacity.
Medical Device Classification Compared: FDA vs EU MDR vs UK vs IMDRF
A comparative guide to medical device risk classification across the US (FDA), EU (MDR), UK (MHRA), and IMDRF frameworks, featuring worked examples of classification divergence.
EU MDR Notified Body Capacity and the 2026-2030 Certificate Expiry Cliff
Data-driven analysis of EU MDR/IVDR certificate expiry timelines, notified body capacity concentration, and manufacturer country exposure using EUDAMED and NANDO data.
Custom-Made Medical Devices Under EU MDR: Annex XIII and the FDA Exemption
A complete guide to custom-made medical devices under EU MDR Annex XIII. Learn about the manufacturer statement, MDCG 2021-3, and FDA CDE comparison.
EU MDR Clinical Investigation Pathway: Sponsor Obligations, EUDAMED, and Timelines
A complete guide to medical device clinical investigations under EU MDR Articles 62-82. Learn about sponsor obligations, EUDAMED submissions, and ISO 14155.
European Health Data Space (EHDS) Regulation: Guide for Medical Device Manufacturers
How Regulation (EU) 2025/327 applies to medical devices and IVDs. Learn about Article 27 software components, CE marking, 2027-2031 deadlines, and GDPR alignment.
Hologic Global Footprint: Genius 3D Mammography, Genius AI, and IVD Market Access
An FDA regulatory and market access footprint dossier of Hologic, mapping Genius 3D Mammography PMA P080003, Genius AI clearances, and Panther diagnostics.
ResMed Global Regulatory Footprint: AirSense 11, Smart Comfort AI, and Market Access
An FDA regulatory and market access footprint dossier of ResMed, mapping AirSense 11 and Smart Comfort AI clearances, product codes, and market shares.
DexCom Global Regulatory Footprint: G7, Stelo, and Market Access
An FDA regulatory and manufacturing footprint dossier of DexCom, mapping G7 and Stelo OTC clearances, product codes QBJ and SAF, and market access.
Intuitive Surgical Global Regulatory Footprint: da Vinci & Ion
An FDA regulatory and commercial footprint dossier of Intuitive Surgical, mapping da Vinci and Ion clearances, product codes, and global market access.
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.
Medical Device Cybersecurity Compared: FDA §524B vs EU MDR/MDCG/CRA
A comprehensive regulatory comparison of medical device cybersecurity requirements under US FDA Section 524B and the EU MDR, MDCG 2019-16, and Cyber Resilience Act (CRA).
Mindray Worldwide Market-Access Footprint: 24-Market Registry Teardown
A comprehensive database analysis detailing Mindray's 6,620 distinct registrations across 24 global markets, including patient monitoring accessories, IVD, and ultrasound segments.
Philips Worldwide Regulatory and Safety Footprint: 26-Market Registry Teardown
A comprehensive database analysis detailing Philips' 7,909 distinct registrations across 26 global markets, integrated with clinical trial data and patent portfolios.
Siemens Healthineers Global Regulatory Footprint: 28-Market Registry Breakdown
A comprehensive database analysis detailing Siemens Healthineers' 18,956 distinct registrations across 28 global markets, including IVD, imaging, and oncology segments.