A device study is not a drug trial with a different product. The pathway depends on risk class and region, the standard is written for devices, and device-specific records matter. Here are ten steps from first question to close-out, and the data setup that makes the later steps easier.
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Month
Classification, investigation plan
Ethics, regulator as required
Forms, training, device supply
Lock, report, archive
The short version
Context
A medical device clinical study tests the safety and performance of a device in people. The product may be a catheter, an implant, a diagnostic, a wearable sensor or a piece of software that meets the definition of a device. Compared with a drug trial, the intervention is often tied to a procedure and a user (the clinician), the product can change between versions during development, and the end-points are frequently performance measures as well as safety outcomes. There is also usually no placebo in the pharmaceutical sense, which makes the design question of comparator and blinding an early decision.
Regulation reflects that. The sponsor needs to understand classification, the right study type for the stage of development and the evidence a notified body or regulator will expect. This page gives you the working outline. The detailed regulatory choices, such as whether your study needs an IDE or a competent authority application, are for your regulatory adviser to confirm against the current texts. For the software angle on the same topic, see EDC for medical device clinical trials and ISO 14155 clinical investigation software.
The process
Order varies by device and region, but most studies pass through each of these.
Write the intended purpose in one paragraph, who uses the device, on whom and in what setting. Then list what you still need to show: safety, performance, usability or clinical benefit. If you cannot state the gap, you cannot design the study.
Risk class and region decide the route. In the US, check whether the study is significant risk (IDE) or non-significant risk (abbreviated requirements, IRB oversight) and whether a pre-submission meeting with FDA would help. In the EU, check the clinical investigation articles and Annex XV of the MDR and the competent authority process in each country. Confirm with a regulatory specialist.
Feasibility, pivotal or post-market. Pick the comparator, sample size logic, primary performance and safety endpoints and the follow-up schedule. A sample size calculator and a schedule of assessments builder help you test the design before it is fixed.
The plan (the protocol for devices) covers rationale, design, device description, procedures, monitoring, adverse event and device deficiency reporting, statistical analysis and data handling. ISO 14155 sets out content expectations. Use a protocol template as a starting structure.
Document the risks to participants and to data quality, and scale monitoring to them. Risk-based monitoring is accepted for device studies; see risk-based monitoring and SDV software. Decide who monitors, how often and what is verified against source.
Ethics committee or IRB approval, and a regulator application where required (an IDE application for significant-risk US studies, a competent authority or notification route in the EU). Prepare the participant information and consent materials in parallel; the IRB submission checklist lists what to assemble.
Build the eCRFs and the schedule from the plan, with device-specific forms. Decide roles, edit checks and the export before you enrol. Test the build in a sandbox. See the data section below.
Train investigators on the plan, the device and the forms. Agree device supply, labelling, storage and return, and keep an accountability log. Assign delegation of duties. Open sites only when approvals, training and system access are in place.
Consent, screen, treat and follow up according to the plan. Track safety events, device deficiencies and deviations as they occur, answer queries and review dashboards routinely. Amendments go through ethics and, where needed, the regulator before the build changes.
Reconcile open queries and events, lock the database, analyse, write the report and archive records for the period your regulations and contract require. Plan the archive early; see clinical trial data archiving and retention.
Pathways at a glance
A simplified orientation, not a substitute for the regulation text or advice.
| Question | United States | European Union |
|---|---|---|
| Main legal framework | FDA regulations including 21 CFR Part 812 (IDE), Parts 50 and 56 (consent and IRB) | Medical Device Regulation (EU) 2017/745, clinical investigation articles and Annex XV, plus national rules |
| Who reviews | IRB; FDA for significant-risk studies under an IDE | Ethics committee and the competent authority in each member state, as the national route requires |
| Risk split | Significant risk vs non-significant risk | Depends on class and on the purpose of the investigation |
| Good clinical practice reference | FDA regulations; ISO 14155 is a recognised consensus standard | ISO 14155 is widely used; check harmonisation status for the edition you follow |
| Safety reporting | Unanticipated adverse device effects and others per Part 812 | Serious adverse events and device deficiencies per the MDR and national rules |
Check the current edition of each source. Secondary sources disagree on some current-edition details of ISO 14155.
Build the visits, device accountability form and adverse device effect form, add edit checks and enter test participants. The free sandbox has every feature, with no credit card and no time limit.
Data setup
Device studies need the usual forms (demographics, eligibility, medical history, concomitant medications, vital signs) and several that are specific. Use the eCRF design guide to keep fields tied to endpoints, then add the device forms below. The same casebook should hold them so that the investigator, monitor and statistician see one record.
Design for the people who will use it. Device investigators are often procedural clinicians with limited time, so keep forms short and put required fields where the procedure data is naturally recorded. Calculated fields can remove arithmetic from the form, and the audit trail records who changed what and why. If your study uses a wearable or sensor, see EDC for wearable device studies.
Not every study needs all of these; the plan decides.
Capture is a self-serve EDC where the study team builds the forms directly.
Device
Device model
DVMODELSerial number
DVSERIALSoftware version
DVSWUsed as intended
DVINTDeficiency
Device deficiency observed
DVDEFIf Yes, an event form opens
Avoiding trouble
Write the purpose (feasibility, pivotal, post-market) in the plan summary and check the pathway with a regulatory adviser before you set a budget.
Capture the version at every use. If the device changes mid-study, treat it as a plan amendment and assess the impact on the data.
Make a deficiency question mandatory on every procedure form and train sites on what counts as one.
Record the operator and a learning-curve indicator if the plan expects one, so the analysis can adjust.
Ask your adviser whether the study must be registered (for example in ClinicalTrials.gov or the EU database) and when results are due.
Open a test export in the first month. See EDC implementation mistakes.
A clinical study that evaluates the safety, performance or clinical benefit of a medical device in human participants. Depending on region it is called a clinical investigation, a device trial or an IDE study, and it follows the rules for device studies rather than drug trial rules.
No. In the US, significant-risk device studies generally need an Investigational Device Exemption under 21 CFR Part 812, while non-significant-risk studies follow abbreviated requirements under IRB oversight. Some studies are exempt. Confirm with FDA guidance and your IRB.
ISO 14155 is the international good clinical practice standard for clinical investigations of medical devices in humans. Check which edition is current and how your regulator treats it before you write the plan.
It varies widely with risk class, regulator and follow-up length. Feasibility studies can run in months, pivotal studies often take years. Use a timeline planner with realistic approval and enrolment assumptions.
Device identification and accountability, software versions, procedure and operator details, device deficiencies and malfunctions, and usability measures, in addition to the usual safety and efficacy data.
Yes, many do, but the sponsor remains responsible for compliance. A clear plan, a regulatory adviser, a monitoring approach scaled to risk and a self-serve data system you control keep the workload manageable.
Capture is a self-serve EDC with eCRF builder, ePRO, eConsent, audit trail and exports, suitable for Phase 1 through 3 and device investigations. You build the device-specific forms yourself in a free sandbox.
Keep exploring
EDC for medical device clinical trials
Software for device studies.
ISO 14155 clinical investigation software
Standard and system.
Early feasibility and pivotal device study EDC
Study stages.
IRB submission checklist
What to prepare.
How to design an eCRF
Form design.
Risk-based monitoring and SDV software
Scaled monitoring.
Post-market studies
After clearance or approval.
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