EU MDR / IVDR
144 articles
Is This Combination an MDR Device or a Medicinal Product?
A manufacturer guide to EU MDR Article 1(8) and 1(9): classify integral ancillary devices, medicinal products, and administration devices with the four-scenario identity worksheet.
MDCG 2026-4: Who Uploads SSCP and SSP to EUDAMED, the Handover, and 2027 Clocks
MDCG 2026-4 EUDAMED SSCP and SSP upload guide: NB interim duties, manufacturer handover in October 2026, Article 32 vs 29(4), and the 27 February 2027 clock.
ISO 20417:2026 Guide: FDA Rec# 5-149, July 1 2029 DoC Window & ISO 15223-1
Operational guide to ISO 20417:2026: FDA Rec# 5-149 complete recognition, the July 1 2029 DoC transition window, ISO 15223-1, 21 CFR 801, and EU MDR GSPR 23.
DHTs as Endpoints in Device Investigations: Investigational Device vs Measurement Tool
FDA DHT clinical investigation guide: investigational device vs remote measurement tool under 21 CFR 812, fit-for-purpose V&V, and August 2026 DDM status.
ISO 80369 Small-Bore Connector Conversion: 510(k), FDA Windows & Particular Parts
Manufacturer ISO 80369 conversion guide: route-specific particular parts, FDA recognition transition windows through Dec 17, 2028, and 510(k) change forks.
MHRA Ambient Voice Technology 2026: When an AI Scribe Is a Medical Device in Great Britain
MHRA and NHS England 2026 guidance on ambient voice technology (AVT): 9-example medical device qualification tree, Class I vs IIa, DCB0129, and UKCA strategy.
MDCG 2026-5 UDI Assignment: Manufacturer vs Distributor Decision Tree
MDCG 2026-5 UDI assignment guide: 3-path decision tree for private-label distributor brands, MDR Article 16, Basic UDI-DI rules, and EUDAMED registration.
Medical Device Expanded Access: Emergency Use, Compassionate Use & Treatment IDE
Operational guide to US investigational device expanded access: emergency use, compassionate use IDE supplements, Treatment IDE (21 CFR 812.36), and IRB rules.
NSAI NB 0050 Medical Devices Divestment 2026: Stay vs Transfer Playbook
Playbook for NSAI NB 0050 clients on the 2026 divestment: confirmed facts, stay-vs-transfer tree, MDR Article 58, IVDR Article 53, MDSAP.
Medical Device Trial Master File (TMF) and ISF Guide: ISO 14155, FDA, and EU MDR
Complete guide to medical device TMF and ISF: ISO 14155:2026 Annex E essential documents, 21 CFR 812.140, EU MDR archiving, and device-unique artifacts.
IVDR Performance Study Requirements: Application vs Notification, Timelines, and Reporting
Comprehensive guide to IVDR Chapter VI performance studies: Article 58 application triggers, Article 70 PMPF notifications, Article 66 timelines, leftover samples, and safety reporting.
ClinicalTrials.gov Registration and Results Reporting for Medical Device Trials
Comprehensive guide to medical device clinical trial registration and results reporting: 42 CFR Part 11 ADCT criteria, 21-day clocks, Form FDA 3674, 2026 CMP updates, and EU MDR Article 77.
Informed Consent for Medical Device Clinical Trials: 21 CFR 50, EFIC & EU MDR Article 63
Complete guide to informed consent in medical device clinical trials: 21 CFR Part 50 & Part 812, 50.22 minimal-risk waiver, 50.24 EFIC, and EU MDR Article 63.
Safety Reporting in Medical Device Clinical Trials: US IDE, EU MDR & ISO 14155
Complete guide to safety reporting in medical device clinical trials: 21 CFR 812.150 UADE clocks, EU MDR Article 80, MDCG 2020-10/1 Rev.1, and ISO 14155 GCP rules.
Risk-Based Monitoring for Medical Device Clinical Trials: FDA, EU MDR & ISO 14155 Guide
Comprehensive guide to risk-based monitoring (RBM) in medical device clinical trials: 21 CFR 812.40, FDA 2023 Q&A, EU MDR Annex XV, ISO 14155:2026, and BIMO audit evidence.
Protocol Deviations in Medical Device Clinical Trials: FDA Guidance and EU Rules
Comprehensive guide to protocol deviations in medical device clinical trials: FDA draft guidance, 21 CFR 812, EU MDR Article 75, ISO 14155:2026, and BIMO metrics.
Sham Controls in Medical Device Trials: Design, Ethics, and FDA/EU Expectations
Comprehensive guide to sham controls in medical device clinical trials: 21 CFR 860.7, EU MDR Article 62, Helsinki ethics, blinding protocols, and alternatives.
Pure Global AI: A Practical Workflow Guide for Medical Device Regulatory Teams
A vendor-neutral guide to Pure Global AI's regulatory databases, device and predicate agents, and evidence-first workpapers for risk, eSTAR, CAPA, QMSR, labeling, and post-market review.
Why Medical Device Clinical Trials Stop Early: 6,155 Terminated Studies Analysis
Analysis of 6,155 terminated medical device trials on ClinicalTrials.gov: leading failure causes, enrollment bottlenecks, and trial survival playbooks.
EU MDR Article 22: Systems and Procedure Packs — Producer Obligations Guide
Complete guide to EU MDR Article 22 system and procedure pack producer obligations, the no-additional-CE-mark rule, Article 22(4) triggers, UDI, and the FDA convenience-kit comparison.