EU IVDR 2017/746
The regulation for in vitro diagnostic devices: products intended for the in vitro examination of specimens taken from the human body, such as blood, urine or tissue (IVDR Art. 2(2)). A wearable or sensor that measures in or on the body is never an IVD, whatever result it reports. Whether a product falls under IVDR or MDR is decided by the manufacturer’s intended purpose, not by the trial protocol.
ALCOA+ on the Device: Device-Side Data Integrity in GCP
When a device captures trial data — a handset, a wearable, a home instrument or the gateway that relays them — attribution, time and protection against alteration are decided on the device, and no validated database can decide them later.
Open the paper →DeviceFit — fit-for-purpose validation
Technical, clinical and operational validation aligned to ISO 14971, IEC 62366-1, FDA QSR, EU MDR Annex I and ICH-GCP.
Open the paper →Global Reconciliation: FDA, EU, PMDA, NMPA and UK Requirements for DHTs
Why the shared requirements carry across markets and the local differences do not — and how to decide when a per-jurisdiction assessment is actually needed.
Open the paper →Vigilance and Post-Market Surveillance for Trial DHTs
Why the reporting route turns on what the device is — and why meeting one route never discharges another.
Open the paper →Who Is the Manufacturer? Economic-Operator Roles in DHT Supply Chains
How provisioning, importing, kitting and modifying a device assign manufacturer, importer and distributor duties — often by operation of law.
Open the paper →Are Consumer Devices (e.g. Fitbits, …) Compliant for Endpoint Data Collection?
Can consumer wearables like Fitbits generate regulatory-grade clinical trial data? What risks arise when sponsors use consumer devices for endpoint…
Read the article →Best Practices for Usability Testing in DHTs
What makes usability testing a regulatory requirement for DHTs? How can poor usability compromise data integrity in decentralised trials? What are the most…
Read the article →Device Fit and Classification: When “Commercial” Becomes “Clinical” (Part 3/8)
Have you validated every DHT used in your trial for analytical, clinical, and usability accuracy? Are you certain of each device’s risk class in all…
Read the article →FDA’s Final Guidance on Cybersecurity in Medical Devices: Insights and a Comparison with EU Frameworks
What the FDA’s 2023 final guidance on cybersecurity in medical devices asks of manufacturers — security risk management within the quality system and the content of premarket submissions — and how it compares with the EU frameworks.
Read the article →Fit-for-Purpose or Bust: A Real-World Rubric for DHT Verification, Validation & Usability
What makes a DHT truly “fit-for-purpose” in a clinical trial context? How do verification and validation differ—and why does it matter? What role does…
Read the article →From Compliance Burden to Competitive Edge: How DHT Readiness Can Shorten the Path Through Review
Can building DHT compliance into trial design, rather than adding it later, mean fewer regulator questions and less rework? Is your compliance programme adding time to your timelines—or saving it?
Read the article →How to Survive – and Win – in the New Digital Health Economy (Part 8/8)
Is your organisation’s QMS built to manage devices, data, and endpoints together? Would your DHT-derived evidence survive a multi-country audit? Who in your…
Read the article →Meet the New Digital Health Reality: How to Make Your DHT Trials Regulator-Ready in 2026
Will your digital endpoints still hold up under regulatory scrutiny in 2026? Could you explain your DHT data pipeline to an inspector—without guessing? Are…
Read the article →Navigating AI Regulations: Insights on FDA’s AI/ML Guidance and the EU AI Act
How do the FDA's AI/ML guidance and the EU AI Act differ in regulating AI in life sciences? What challenges do life sciences companies face when complying…
Read the article →Navigating CE Marking and Global Compliance for DHTs in Clinical Trials
Does your CE mark actually protect you outside the EU? Most sponsors assume it does — until their US arm hits an IDE requirement. What happens when the MHRA…
Read the article →Not in EUDAMED? If You Import the Device, the Obligations Are Already Yours
Who is the importer of record for the devices in your trial — and does that person know it? If a device on your study isn’t in EUDAMED, can you still legally…
Read the article →Reverse Logistics: Recovering DHTs Without Breaking Data Chains
How can sponsors eliminate “data breaks” across global DHT logistics networks? What are regulators expecting in traceability documentation under MDR and GCP?…
Read the article →Roles Redefined: Manufacturer, Importer, System Producer — Which Are You? (Part 6/8)
Are you certain your organisation’s role under MDR or FDA law is correctly defined? Have you appointed authorised importers or representatives for DHT…
Read the article →Sponsor Oversight of Digital Health Technologies in Decentralised Clinical Trials: A Regulatory Guide
How do sponsors avoid becoming “accidental manufacturers” when deploying wearables in trials? What happens if a consumer-grade DHT fails to meet regulatory…
Read the article →The DHT Compliance Wake-Up Call: Why “Digital-Ready” Isn’t “Regulator-Ready” Anymore
Could you reconstruct any digital endpoint in your trial for an inspector—without opening PowerPoint? Is your DHT compliance actually regulator-ready, or…
Read the article →The DHT-Ready QMS: Integrating Device, Data, and Clinical Quality into One System (Part 2/8)
Does your QMS include design-history and validation records for every DHT you use? Are firmware, algorithms, and human-factors results governed under change…
Read the article →The Global Compliance Map: Deploying DHTs Across Borders (Part 7/8)
Are your DHTs classified and registered in every country where they’re used? Have you appointed local importers and authorised representatives? Do your…
Read the article →The May 2026 EUDAMED Deadline: What It Means for Digital Health Technologies in Clinical Trials
The first EUDAMED modules became mandatory on 28 May 2026 — is the wearable sensor in your trial registered, and did it need to be? What happens to your EU clinical trial if the device manufacturer…
Read the article →The ROI of Seeking External Advice for Medical Device Companies: Why Expert Support is a Smart Investment
How can seeking external expert advice accelerate your medical device’s time to market? What is the ROI of engaging external consultants for your medical…
Read the article →Walking the Compliance Tightrope: The Risks and Challenges of Being the PRRC in the Medical Device Industry
What are the primary responsibilities of a Person Responsible for Regulatory Compliance (PRRC) in the medical device industry? How does the PRRC ensure…
Read the article →“It’s Just a Phone”
Did you know a consumer smartphone can trigger four separate regulatory frameworks the moment it touches a clinical endpoint? Why do so many sponsors fail…
Read the article →A document appears here because it names EU IVDR 2017/746 in its own text. Nothing is inferred: this is what we have actually written about it.