Clinical evidence · EU MDR · ISO 14155
Design the investigation around the evidence decision
MDRC plans, documents and supports EU MDR clinical investigations that connect a defined clinical evidence gap to a feasible study, controlled data and a usable regulatory conclusion.
Evidence gap
Intended purpose
Risk profile
Question · design · endpoints · data · conclusion
Before the protocol
A clinical investigation is not evidence generation in the abstract
The investigation should answer a defined safety, performance or clinical-benefit question that the existing evidence cannot resolve. The device, claim, population and regulatory decision must therefore be controlled before the protocol is written.
Define the decision
State which conformity-assessment, clinical-evaluation, PMCF or product-development decision the study must support.
Locate the evidence gap
Use the clinical evaluation and risk file to distinguish a real uncertainty from a documentation or analysis problem.
Control the population
Connect eligibility, setting, users and follow-up to the intended purpose and the people who will use or receive the device.
Test feasibility early
Check recruitment, comparators, endpoint collection, site capability, device supply, timelines and country requirements.
Commercial deliverables
Receive a controlled investigation package
We can support the full investigation pathway or a defined work package. The scope is set around the device, the applicable MDR route, the target countries, the sponsor organisation and the evidence decision.
Define the project scopeClinical evidence and study strategy
A traceable rationale for the investigation question, route, design concept, countries and connection to the clinical evaluation.
Clinical Investigation Plan
A CIP and synopsis structured around Annex XV, the applicable MDCG guidance, ISO 14155 and the planned regulatory use.
Investigator’s Brochure
A controlled presentation of device, pre-clinical, clinical, risk and handling information needed by investigators.
Subject-facing materials
Information and informed-consent materials aligned with the study, foreseeable risks, local requirements and intended participants.
Operational study documents
Case-report forms and plans for monitoring, data management, statistics, safety handling, device accountability and deviations.
Application and response package
A structured competent-authority and ethics submission set with document tracking and support for questions or deficiencies.
Study oversight support
Controlled interfaces with sites, investigators, CROs and specialist vendors, including changes, escalation and evidence records.
Closeout and reporting
Clinical investigation reporting, lay summary support and integration of conclusions into the CER, risk file and lifecycle plans.
Working method
Control the investigation from question to regulatory use
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01
Frame
Define the evidence question
Confirm the device, intended purpose, claim, risk, existing data, residual uncertainty and intended regulatory decision.
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02
Route
Select the regulatory pathway
Determine whether Article 62, Article 74, Article 82 or another applicable national route governs the planned work.
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03
Design
Choose a defensible study design
Align population, comparator, endpoints, sample size, analysis, follow-up and risk controls with the evidence question.
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04
Document
Build one consistent dossier
Prepare the CIP, Investigator’s Brochure, subject materials and operational plans from the same controlled assumptions.
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05
Submit
Prepare the authority and ethics process
Map country requirements, assemble applications, manage versions and coordinate complete responses to review questions.
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06
Use
Return the results to the evidence system
Close and report the study, explain limitations and update the clinical evaluation, risks, claims and post-market plans.
Study design
Every design choice must serve the evidence question
A protocol becomes defensible when its scientific choices, operational controls and regulatory purpose agree. Copying a previous design cannot substitute for product-specific justification.
Population and setting
Eligibility, clinical context, users and sites reflect the intended purpose while protecting participants and controlling confounding.
Comparator and control
The choice of concurrent, historical, objective-performance or other control is scientifically and ethically justified.
Endpoints and measurements
Outcomes are clinically meaningful, valid, consistently assessed and connected to the claimed benefit, performance and safety.
Sample size and analysis
Assumptions, estimands, missing-data handling, analysis populations and statistical methods support an interpretable conclusion.
Duration and follow-up
Observation covers the clinically relevant performance period and foreseeable early, late or cumulative risks.
Risk controls and oversight
Monitoring, safety reporting, stopping rules, device accountability and escalation are proportionate to participant and study risk.
Responsibility map
Delegate defined tasks without losing sponsor control
Written agreements should state who prepares, reviews, approves, performs, records and escalates each task. Delegation does not remove the sponsor’s responsibility for compliant conduct and reliable results.
Sponsor
Owns the investigation strategy, authorisations, oversight, safety governance, data integrity, reporting and regulatory use of the results.
MDRC
Provides agreed regulatory, clinical and documentation work, controls interfaces and makes gaps or decisions visible to the sponsor.
Investigator and site
Protect participants, obtain informed consent, follow the approved CIP, document data and report safety information and deviations.
CRO and specialist vendors
Perform contracted operational tasks within qualified systems, documented responsibilities and the sponsor’s oversight model.
Competent authority and ethics body
Review the investigation under the applicable legal route and national procedure before and during authorised conduct.
Notified body
Assesses the clinical evidence within conformity assessment where notified-body involvement applies, but does not manage the study.
Regulatory routes
Classify the investigation before building the submission
The purpose of the investigation, CE-marking status, use within or outside the intended purpose and the target Member States affect the procedure. The route should be confirmed before documents and timelines are fixed.
Conformity-assessment investigation
Article 62 and Annex XV govern investigations conducted to establish conformity with relevant safety and performance requirements.
PMCF investigation
Article 74 addresses specified investigations involving CE-marked devices used within the intended purpose covered by the conformity assessment.
Other clinical investigation
Article 82 sets core protections for investigations outside the purposes listed in Article 62, with additional Member State provisions possible.
Multinational pathway
Country selection, ethics interfaces, national documents and any available coordinated-assessment route require early procedural mapping.
The MDR generally requires clinical investigations for class III and implantable devices, subject to specific exceptions and conditions in Article 61. For other devices, a clinical investigation may still be necessary when the available evidence is not sufficient for the intended purpose, risks and claims.
Review clinical evaluation servicesOperational control
Keep the approved design intact while the study changes
Start-up
Control approvals, contracts, site readiness, training, device supply, document versions and required trial records.
Conduct
Monitor consent, eligibility, CIP compliance, source data, device accountability, deviations and data completeness.
Safety and change
Assess and report adverse events and device deficiencies, manage urgent measures and control substantial modifications.
Close and report
Reconcile records, lock the data, analyse results, report the investigation and update the clinical evidence system.
When to involve MDRC
Use the service before the design becomes expensive to change
Early regulatory and clinical alignment reduces avoidable protocol amendments, inconsistent submissions and data that cannot answer the intended question.
First-in-human planning
Translate pre-clinical readiness, risk controls and early clinical objectives into a proportionate initial investigation.
Pivotal investigation
Build the design and document set around the evidence expected for conformity assessment.
PMCF investigation
Address residual uncertainty, long-term outcomes or performance in routine use with a defined post-market study.
Authority questions
Repair inconsistencies, supply missing justification and coordinate controlled responses without creating document drift.
Protocol amendment
Assess the scientific, participant-safety, regulatory and documentation effects before implementing a material change.
Study closeout
Convert analysis into the required reports and integrate the result into the clinical evaluation and risk system.
Connected work
Place the investigation inside the complete evidence system
Clinical evaluation
Define the evidence gap and interpret the investigation result within the complete clinical evidence package.
View service → 02Post-market surveillance
Connect PMCF investigations and their findings to systematic post-market collection, analysis and action.
View service → 03Technical documentation
Integrate the protocol, report and conclusions with GSPRs, risk management, labelling and change control.
View service → 04Regulatory strategy
Sequence evidence generation with classification, conformity assessment and market-access decisions.
Explore the strategy →Regulatory basis
Use the current MDR framework and applicable guidance
The exact application, ethics and reporting pathway remains country- and study-specific. Guidance supports interpretation and document quality but does not replace the MDR, national requirements or product-specific scientific judgement.
Regulation (EU) 2017/745
Articles 61 and 62–82, with Annex XV for clinical investigations
MDCG 2024-3
Guidance on the content of the Clinical Investigation Plan
MDCG 2024-5
Guidance on the content of the Investigator’s Brochure
MDCG 2021-6 revision 1
Questions and answers regarding clinical investigation under the MDR
MDCG 2024-15
Publication of clinical investigation reports and summaries while EUDAMED is unavailable
MDCG guidance collection
Current clinical investigation forms, templates and guidance documents
Frequently asked questions
Clinical investigations in practice
Does every medical device need a clinical investigation?
No. The need depends on the device, intended purpose, classification, novelty, claims and sufficiency of available clinical evidence. The MDR generally requires investigations for class III and implantable devices, subject to specific exceptions and conditions in Article 61.
What is the difference between a clinical evaluation and a clinical investigation?
Clinical evaluation is the lifecycle process that identifies, appraises and analyses clinical data. A clinical investigation is a planned study involving human subjects that generates clinical data to answer defined safety, performance or clinical-benefit questions.
Which MDR route applies to the investigation?
The route depends on purpose and device status. Article 62 addresses conformity-assessment investigations, Article 74 addresses specified PMCF investigations involving CE-marked devices within their intended purpose, and Article 82 covers other clinical investigations subject to applicable Member State provisions.
What documents are normally needed for an EU MDR application?
The set commonly includes the CIP, Investigator’s Brochure, subject information and consent materials, application forms, insurance or indemnification evidence where applicable, investigator and site information, and supporting safety, data and monitoring documents. Exact requirements depend on the route and Member State.
Can sponsor tasks be delegated to MDRC or a CRO?
Defined tasks can be delegated through controlled agreements, but delegation does not remove the sponsor’s regulatory responsibilities. Roles, decision rights, oversight, records and escalation routes should be documented before work begins.
What happens after the clinical investigation ends?
The investigation must be closed and reported under the MDR and applicable national requirements. The clinical investigation report and its summary are then integrated into the clinical evaluation, risk management and other affected technical documentation.
Start with the clinical question
Plan the evidence before committing to the study
Tell us the device, intended purpose, classification, market status, existing clinical evidence, target countries and the decision the investigation must support. We will define a proportionate scope, route and set of controlled deliverables.