EU MDR 2017/745
Classification, economic-operator roles, technical documentation and post-market obligations for any device placed on the EU market. In a trial it bites twice: a technology can meet the device definition on intended use alone, and supplying a CE-marked or commercial device to sites or participants can make the sponsor or CRO an importer or distributor under Chapter II without anyone deciding to become one. Investigational devices are not placed on the market; they follow the clinical-investigation rules instead.
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 →ALCOA++ in the Age of Digital Health Technologies (Part 5/8)
Can your audit trail reconstruct every DHT data transformation from source to submission? Are firmware, algorithms, and databases synchronised under one…
Read the article →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 →DHT QMS: The Missing Link Between Mature Systems and Digital Health Readiness
Is your QMS framework prepared to manage device-level risk and traceability? How can sponsors extend quality oversight to digital endpoints without…
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 →Endpoints and Algorithms: How Firmware Can Break Your Study (Part 4/8)
Can a single firmware update, algorithm change or data-sync failure invalidate months of trial data? How did the FDA’s DHT guidances change who answers for endpoint traceability and version control?
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 →From Concept to Market: Best Practices for Developing Compliant Safety-Critical Medical Software
What are the essential regulatory requirements for developing safety-critical medical software? How can a robust quality management system enhance compliance…
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 →ICH GCP E6 Is Changing — And Digital Health Technologies Are at the Centre
For years, Digital Health Technologies lived slightly outside the GCP spotlight. Useful? Yes. Innovative? Absolutely. GCP-critical? Not always. ICH GCP E6 (R3) changes that.
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 →Risk-Based Quality Management (RBQM) in the Medical Device Industry: Strategies for Effective Implementation
Are you focusing your quality efforts on the right areas, or are you spreading resources too thin? How can risk-based quality management streamline your…
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 Importance of Cybersecurity in Medical Device Manufacturing: Safeguarding Patient Data and Ensuring Regulatory Compliance
How can robust cybersecurity measures safeguard patient data in medical device manufacturing? Are your medical devices protected from cyberattacks that could…
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 →The Shockwave: What the FDA’s DHT Framework Really Means (Part 1/8)
Are your current DHTs validated for analytical, clinical, and usability accuracy? Who in your organisation owns responsibility for device version control?…
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 →When a Digital Health Tool Becomes a Medical Device: The Hidden Regulatory Roles No One Told You About
If your digital health tool is already collecting endpoint data, are you absolutely sure regulators don’t see it as a medical device? Who’s carrying the…
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 MDR 2017/745 in its own text. Nothing is inferred: this is what we have actually written about it.