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ISO 14155:2026 · Medical device clinical investigations · European and international delivery

ISO 14155:2026 CRO for Medical Device Clinical Investigations

Design and execute your medical device clinical investigation with one specialist CRO across protocol, regulatory start-up, sites, monitoring, data, safety and clinical reporting. Eclevar translates ISO 14155:2026 requirements into the operational controls needed to generate credible clinical evidence suitable for regulatory use.

From first site strategy to database lock and Clinical Investigation Report, the same program governance connects clinical decisions to execution.

Discuss Your Clinical Investigation Review Relevant Clinical Programs
Device-specialist CRO

Investigations designed around device-specific risks, procedures, learning curves and evidence requirements.

ISO 14155:2026

Clinical operations structured around the current ISO edition and the applicable regulatory and ethics requirements.

Integrated clinical delivery

Strategy · Start-up · Sites · Monitoring · Data · Safety · Reporting

European execution

30+ device evidence programs · 2,000+ participants across delivered programs · regulatory and ethics submission experience across six European jurisdictions

The execution problem

Your ISO 14155 Clinical Investigation Is More Than a Monitoring Project

The clinical question can be sound and the investigation can still run into trouble operationally.

The trouble usually has a location. It is the seam where a design assumption meets a clinical workflow that cannot support it. A procedure that reads cleanly in the clinical investigation plan can add forty minutes to a theater list. A site can qualify on paper and then be unable to supply the imaging modality an endpoint depends on. A deviation pattern flagged in month three can become a reconciliation problem in month fourteen, when fixing it costs most and the options are fewest.

Six recurring failure modes appear repeatedly in device investigations:

  • Protocol and site workflow mismatch. Study procedures the site cannot absorb into its real clinical routine.
  • Weak feasibility. Enrollment built on investigator estimates rather than verified patient flow and site capability.
  • Learning curve and training. Inconsistent training on a device where operator technique moves the endpoint.
  • Device accountability. Traceability recorded differently at each site, and a recurring source of reconciliation work at close-out.
  • Escalation. Safety and deviation pathways documented but never rehearsed, so a pattern can reach the sponsor as an isolated incident.
  • Fragmented data and vendor governance. Data capture, imaging, statistics and medical writing answering to different masters, with the sponsor as the integration layer.

Sponsors do not buy knowledge of ISO 14155. They buy the operational controls that make the requirements survive contact with real sites.

Eclevar is built for that seam. Program governance keeps clinical design and study delivery connected from planning through reporting.

Figure 1 · One accountable program governance

SponsorOwns the device, the claims and the evidence objective
One accountable program governanceDelivered by Eclevar
Regulatory and ethics

Submissions, approvals tracking, site documentation.

Sites and investigators

Qualification, activation, training, site management.

Monitoring

Risk-based oversight, deviation management, escalation.

Safety and device oversight

Adverse event and device deficiency pathways.

Data management, biostatistics and quality
Clinical evidence intended to support EU MDR clinical evaluation

Findings inform the next design decision, back through program governance

The sponsor keeps ownership of the device, the claims and the evidence objective. Four workstreams run in parallel under one accountable program governance and converge into data management, biostatistics and quality before the evidence is reported. The figure describes an operating model, not a regulatory outcome.

What you get: one accountable program governance, one escalation path, and design decisions taken with the people who will execute them.

Selected programs

Medical Device Clinical Investigation Experience

Three programs, chosen because each demonstrates a different execution capability.

Coloplast Continence care · Denmark, France, United Kingdom Pre-market clinical investigation, completed

Comparative pre-market evidence for a device the participant uses at home

Device and program

A compact hydrophilic ready-to-use intermittent catheter, not CE marked at the time of the investigation, studied against CE marked comparators.

Challenge

Generate comparative pre-market evidence in a population that self-administers the device at home, where the study procedure is the participant's daily routine rather than a procedure performed at a site.

Study design

Multicenter, randomized, open-label, crossover. Registered plan of 72 participants, four weeks per participant, four site visits and two home-use periods of two weeks. Registered as NCT05814211, protocol CP348.

Eclevar's role

Clinical investigation delivery across the three participating countries: site-facing operations, monitoring, data capture, and the study documentation required for per-participant comparator allocation.

What this demonstrates

Home-use data collection, crossover allocation control, and coordination across three national regulatory routes inside one investigation.

No clinical results, endpoints or regulatory outcomes are presented. Eclevar's involvement is limited to its contracted scope. Registered study information is drawn from the public registry record.

RegenLab Advanced wound care · France, United Kingdom, Germany, Italy, Spain Randomized post-market clinical investigation

One randomized investigation across two chronic wound indications and five countries

Device and program

An advanced wound care technology studied in diabetic foot ulcer and venous leg ulcer populations.

Challenge

Run one randomized investigation across two chronic wound indications and five countries, with wound assessment consistent enough across sites and assessors to survive analysis.

Study design

Randomized, multicenter, two indications, 160 participants planned across 14 sites in five European jurisdictions, running on the Milo platform.

Eclevar's role

Study architecture, regulatory and ethics submissions prepared and filed in-house, site activation and management, monitoring, and the connected data environment supporting site data capture.

What this demonstrates

Multicountry operational coordination at scale, standardized wound assessment across countries, sites and assessors, and in-house submission capability across five jurisdictions.

No clinical results are presented. Evidence is intended to support EU MDR clinical evaluation and post-market clinical follow-up activities. Client name and logo used with permission.

JRI Orthopaedics Orthopedics · United Kingdom Two-part pre-market clinical investigation, in progress

Two questions, two time horizons, one program

Device and program

A ceramic hip resurfacing system, studied in a two-part pre-market clinical investigation.

Challenge

Answer two questions at two time horizons within one program, early safety and performance and then long-term clinical performance, without letting the early design constrain the later one.

Study design

Two-part clinical investigation. Part one addresses early safety and performance. Part two addresses long-term clinical performance, with patient-reported outcomes integrated from the start.

Eclevar's role

Investigation strategy, synopsis and endpoint architecture, long-term follow-up planning, patient-reported outcome integration, digital data capture and statistical methodology.

What this demonstrates

Long-term implant follow-up design, endpoint architecture spanning two study parts, and patient-reported outcome integration planned before the first participant rather than retrofitted.

Program in progress. No results, enrollment completion or regulatory outcome is claimed.

  • Meril Life Sciences · Structural heart · Multicenter transcatheter aortic valve program, eight United Kingdom cardiac centers, more than 600 participants planned. Ongoing program, currently enrolling.
  • Perouse Medical (Vygon Group) · Vascular · Six registered observational post-market studies across three implantable device families, on one harmonized study model.

See the full set of Eclevar client programs

Scope of delivery

One CRO Across the ISO 14155 Clinical Investigation Lifecycle

Strategy · Protocol · Feasibility · Start-up · Sites · Monitoring · Safety · Data · Evidence

  1. Clinical and regulatory strategy

    Evidence objective, claims to be supported, country strategy, and the operational cost of each endpoint established before it is fixed. See EU MDR regulatory strategy.

  2. Protocol and study documentation

    Clinical investigation plan development or review, informed consent documentation, case report form design, and the monitoring strategy the plan will be held to.

  3. Feasibility and site selection

    Country assessment, investigator identification, site qualification against the actual study procedure, and enrollment assumptions tested against verified patient flow. See feasibility and site selection.

  4. Regulatory and ethics start-up

    Submissions coordinated through Eclevar's clinical and regulatory team, with local interfaces used where required by the national route, plus site document collection and approval tracking. See study start-up.

  5. Site activation and investigator training

    Site initiation, protocol and device-specific workflow training, and study system readiness confirmed before the first participant is approached.

  6. Clinical monitoring

    Risk-based monitoring strategy, on-site and remote oversight, source data review and verification as applicable, and deviation management with a defined escalation route. See clinical monitoring.

  7. Safety and device oversight

    Adverse event and device deficiency handling within the reporting pathways defined for the investigation, with the escalation route rehearsed before activation.

  8. Data management and biostatistics

    Database design, edit checks, query management, data cleaning, coding where applicable, statistical analysis planning and analysis, and a controlled database lock. See clinical data management and EDC, and the statistical methods ISO 14155 expects you to prespecify.

  9. Close-out and clinical reporting

    Site close-out, reconciliation, essential documentation completion, and the Clinical Investigation Report.

What you get: clinical planning and study delivery connected under the same program governance, from strategy to the Clinical Investigation Report.

Accountability

Where Sponsors Lose Control of a Device Investigation

The difference between a program that stays controllable and one that does not is rarely the protocol. It is who holds the connections between the functions.

Figure 3 · Fragmented delivery compared with integrated governance

Fragmented delivery

  • Protocol
  • Multiple vendors
  • Sites
  • Disconnected data
  • Late surprises

Eclevar governance

  • Strategy
  • Sites, monitoring, safety and data under one governance
  • Integrated escalation
  • Clinical evidence
Two delivery models compared. The left panel describes a fragmented model, not any particular organization. The right panel describes how Eclevar connects the same functions under one program governance.

What you get: fewer handoffs, and the sponsor is not the integration layer.

The standard, operationalized

ISO 14155:2026 Embedded Into Study Execution

ISO 14155:2026 is the fourth edition of the international standard specifying good clinical practice for the design, conduct, recording and reporting of medical device clinical investigations in human participants. Published in March 2026, it replaced ISO 14155:2020. Its objectives cover participant rights, safety and well-being, scientifically sound investigations, credible results, sponsor and investigator responsibilities, and a common reference for the parties involved in conformity assessment.

The fourth edition does not rewrite good clinical practice. It clarifies and strengthens it, in areas including residual risk assessment, risks arising from study procedures as distinct from the device, data monitoring and clinical events committee arrangements, adverse event reporting, participant follow-up, missing data, and estimands. More of the standard now has to be visible in how the investigation is run, not only in how it was planned. The 2026 edition should be reviewed against the investigation's existing procedures, monitoring plan, data oversight and study governance to determine what changes are relevant to the specific program.

The standard does not stand alone. An investigation also has to satisfy the applicable EU, national, ethics and competent authority requirements of every country in which it runs, and those differ.

Figure 2 · From requirements to credible clinical evidence

ISO 14155:2026Good clinical practice for medical device clinical investigations
Applicable regulatory and ethics requirementsEU, national, ethics committee and competent authority
Participant protectionConsent processes defined and trained
Study designEndpoints tested for operational feasibility
Sponsor oversightNamed governance and reporting cadence
Investigator responsibilitiesQualification and device-specific training
Risk managementDevice and procedure risks handled separately
MonitoringRisk-based plan, on-site and remote
Safety reportingEscalation pathways rehearsed before activation
Data integrityEdit checks, query resolution, controlled lock
Documentation and reportingEssential records kept as the study runs
Clinical investigation execution
Credible clinical evidence
Requirements from the standard and from the applicable regulatory and ethics framework are translated into nine operational controls, applied during clinical investigation execution. Alignment with the standard supports the credibility of the data set and does not by itself establish any regulatory outcome.
Requirement to operational control. The left column states what the investigation has to satisfy. The right column states what Eclevar puts behind it.
What the investigation has to satisfyThe operational control Eclevar puts behind it
Scientifically sound investigationProtocol, endpoints, eligibility and study procedures reviewed for operational consistency before sites are approached
Protection of participantsStudy procedures, consent processes, site training and safety workflows defined and rehearsed before activation
Sponsor oversightProgram governance, monitoring strategy, escalation route and documentation framework, with a named accountable lead
Risk management across the investigationDevice-related and procedure-related risks handled as distinct categories in the study plans, consistent with the sponsor's risk management file
Investigator and site readinessQualification against the real procedure, activation, training, and continuing site management
Reliable clinical dataDatabase design, edit checks, monitoring, query resolution and a controlled database lock
Traceable study documentationEssential documentation maintained during the investigation, not reconstructed at close-out
Safety oversightDefined adverse event and device deficiency reporting and escalation pathways
Credible final evidenceReconciliation, statistical outputs and a Clinical Investigation Report developed within the same program governance as study execution
Discuss Your ISO 14155 Program

ISO 14155 is not a management-system certification standard analogous to ISO 13485. Sponsors should evaluate how its requirements are implemented in the CRO's study governance, SOPs, monitoring processes and documentation rather than relying on a certificate or logo alone. Eclevar does not certify devices and does not perform conformity assessment. What it does is run the investigation with controls designed to support a traceable, reliable and defensible clinical data set, which then enters the clinical evaluation report.

Scope

Clinical Investigation and Evidence Programs We Support

ISO 14155 clinical investigations

  • Early feasibility and pilot clinical investigations. Small early studies evaluating the design concept and initial clinical safety and device functionality, where the operational question is how fast a design change can be absorbed.
  • Pivotal and pre-market clinical investigations. Confirmatory investigations generating clinical evidence intended to support EU MDR clinical evaluation.
  • Post-market clinical investigations. Studies addressing residual clinical questions and long-term performance after market entry.
  • PMCF clinical investigations, where post-market clinical follow-up is conducted as a clinical investigation.
  • Multicountry European clinical investigations. Any of the above run across more than one national regulatory route.

Complementary post-market evidence

  • Medical device registries. Structured long-term data collection where the evidence question is duration and breadth rather than randomization.
  • Real-world evidence programs. Observational programs built on routine care data, with the design constraints stated rather than assumed.
  • Other PMCF evidence-generation approaches where applicable to the device and its evidence gaps.

The applicable framework depends on the design and purpose of the evidence activity. A registry or other PMCF method is not automatically a clinical investigation under ISO 14155. Understanding which type of clinical investigation your device requires is a separate question, answered in our EU MDR investigation guide.

Country strategy

Country Selection Is a Study Design Decision, Not a Map Exercise

Country selection should be driven by patient access, investigator capability, the regulatory route, realistic start-up timelines and the clinical development objective, not by where a CRO happens to have an office. A country that activates quickly and cannot enroll is worse than a country that takes two months longer and delivers the population.

Europe is not one regulatory route. Requirements for authorization, ethics review and site contracting differ by country and by device, and there is no single uniform European approval. That is a planning input, useful only if treated as one before the protocol is fixed.

Eclevar has regulatory and ethics submission experience across six European jurisdictions: France, the United Kingdom, Germany, Spain, Italy and Denmark. Clinical operations cover the DACH region, and delivery extends to international programs where the development plan requires it.

What you get: a country plan you can defend, with the trade-off between speed and enrollment made explicit.

Entry points

Bring Eclevar In Before Execution Risk Becomes Expensive

Preparing your first clinical investigation

The evidence strategy exists. What is missing is the translation into an executable program: which countries, which sites, which procedures a site can perform, and what each endpoint costs operationally.

Your protocol has not been operationalized

Before activation, feasibility, country routes, study procedures and monitoring requirements are tested against the sites that will run them.

Your study is behind schedule

Recruitment, site performance, monitoring backlog, data quality and escalation history are assessed together. Recruitment problems often trace back to assumptions made at feasibility and site selection.

You are moving toward a regulatory milestone

Clinical execution is aligned with the intended evidence package, so the Clinical Investigation Report answers the questions clinical evaluation will ask of it.

Why sponsors choose Eclevar

Why Medical Device Sponsors Choose Eclevar

Device investigations cannot inherit pharmaceutical trial operations

Device performance can depend on operator learning curves, procedural technique, site capability, imaging consistency, device accountability and changes to the device itself during development. None of that is carried by a protocol template written for drug trials.

Eclevar operationalizes it: site qualification tests the procedure, not just the population. Training is built around the specific device workflow and repeated as the operator base grows. Accountability and traceability are standardized across sites before activation instead of reconciled at close-out. Where an endpoint depends on imaging or technical assessment, reader and assessor consistency is a design decision, not a monitoring finding.

Notified Body review experience

Eclevar's team includes people who previously assessed clinical evidence inside a Notified Body. That perspective helps anticipate the evidence questions a reviewer may raise, while Eclevar remains fully independent from any Notified Body and cannot influence conformity assessment outcomes.

Clinical and regulatory thinking in the same decision

A site is not selected only because it can enroll. A data point is not collected only because it is easy to capture.

Integrated clinical operations

Feasibility, project management, monitoring, data management, biostatistics, medical writing and quality assurance operate as one study team under one governance, not separate delivery streams.

Therapeutic depth

Cardiovascular and structural heart, vascular, orthopedics and spine, advanced wound care, neuromodulation, and diagnostics.

Accountability

The People Behind Your Clinical Investigation

The engagement team is confirmed per program according to the device, therapeutic area, countries, study design and contracted scope.

Prof. Mark Da Costa

Chief Operating Officer and Head of Cardiovascular

Clinical and cardiovascular device strategy. Mark leads cardiovascular clinical strategy, combining 25 years of Consultant Cardiac Surgery experience with first-hand senior leadership Notified Body experience.

Dr. Nikhil Khadabadi

Chief Medical Officer, Orthopedics and Spine

Medical and orthopedic device strategy. Practicing orthopedic surgeon and former clinical reviewer inside a Notified Body, and associate principal investigator on two randomized trials in robotic arthroplasty and personalized osteotomy. On procedure-dependent device programs, learning-curve considerations can materially influence study design, investigator selection, training and endpoint interpretation.

Charline Petitdemange

Project Delivery Lead, France and United Kingdom

Clinical program delivery across European investigations, covering site activation, monitoring execution, site performance escalation and sponsor reporting.

Sébastien Meier Piantanida

Chief Data Officer

Data management and biometrics. Owns electronic data capture architecture, data management, imaging integration and the analysis-ready data set. The people designing the database work within the same program governance as the teams running the sites.

Pierre-Marie Boutanquoi

Head of Medical Writing

Clinical documentation and clinical evidence. Owns the clinical investigation plan, the Clinical Investigation Report and the documentation chain between study conduct and clinical evaluation.

See the full Eclevar leadership team

Before you sign

Five Execution Controls to Verify Before Appointing an ISO 14155 CRO

  1. How is ISO 14155 implemented operationally?

    Ask to see it in the artifacts, not the pitch: standard operating procedures, study templates, monitoring processes, escalation pathways and study governance.

  2. How is investigation-specific risk translated into monitoring?

    Ask how the monitoring plan changes according to device risk, the procedure, the endpoints, the sites and data criticality. A plan that looks the same for every study has not been derived from anything.

  3. How is device accountability controlled?

    Ask about receipt, storage, use, traceability, return or destruction where applicable, and reconciliation. This is where device investigations differ most from drug trials.

  4. How are safety signals and deviations escalated?

    Ask who sees isolated incidents, emerging patterns, serious adverse events, device deficiencies and recurring deviations, and when the sponsor is told about a pattern rather than an event.

  5. Are clinical operations, data and reporting integrated?

    Ask who resolves an inconsistency between a monitoring finding, the data in the electronic data capture system, safety information, the statistical analysis and the Clinical Investigation Report.

These five are execution diligence, specific to running an investigation under the standard. For broader criteria such as therapeutic expertise, European country coverage, senior-team access, CRO size, budgeting and commercial selection, see our medical device CRO selection guide. For scope beyond ISO 14155 execution, including EU MDR regulatory strategy and the wider service portfolio, see Eclevar as a full-service medical device CRO.

Questions

ISO 14155 CRO Questions Sponsors Ask

What does an ISO 14155 medical device CRO do?

It runs a medical device clinical investigation so that the conduct of the study matches the good clinical practice requirements in ISO 14155:2026 and the applicable national and ethics requirements of each participating country. That means translating requirements into operational controls covering site qualification and training, consent, device traceability, deviation and adverse event escalation, data capture and lock, and reporting. A CRO does not certify the device and does not perform conformity assessment.

Is ISO 14155:2026 harmonized under the EU MDR?

As of the latest European Commission harmonized standards list reviewed for this page, ISO 14155:2026 is not yet the edition cited in the Official Journal under Regulation (EU) 2017/745. The cited standard remains EN ISO 14155:2020 together with A11:2024. Sponsors should therefore distinguish between the current ISO edition and the edition currently cited as a harmonized European standard, and confirm the applicable position at the time of their investigation or submission. Eclevar considers the applicable regulatory framework, the relevant harmonized standards and current clinical investigation practice when designing the study approach.

When should a sponsor engage an ISO 14155 CRO?

Before the protocol is fixed, if the choice is available. The expensive decisions are taken early: which endpoints are collected, which countries are opened, which sites are approached and which procedures a site is asked to perform. Once set, a CRO can execute them well but cannot undo them. The second useful moment is after a protocol exists but before activation, when feasibility, country routes and monitoring strategy can still be adjusted. The third is when a running study is behind schedule.

Can Eclevar manage an investigation from protocol to Clinical Investigation Report?

Yes. Eclevar covers the full lifecycle set out above, from clinical and regulatory strategy through feasibility, submissions, site activation, monitoring, safety oversight, data management and biostatistics, close-out and the Clinical Investigation Report, under one program governance rather than separate workstreams. Scope is confirmed contractually and depends on the device, the study design and the countries involved.

Does ISO 14155:2026 apply to post-market clinical investigations?

The standard states that its principles are intended to be followed for post-market clinical investigations as far as relevant, considering the nature of the investigation. Expectations around participant protection, consent, data integrity, safety reporting and documentation still apply, while the design and level of intervention differ. Where PMCF is conducted as a clinical investigation, the relevant ISO 14155 principles continue to apply alongside the applicable EU MDR post-market requirements. Other PMCF methods may follow different methodological and regulatory frameworks.

Can Eclevar manage multicountry European clinical investigations?

Yes. Eclevar has regulatory and ethics submission experience across France, the United Kingdom, Germany, Spain, Italy and Denmark, and has delivered randomized multicountry investigations across five European jurisdictions. Multicountry delivery is a planning discipline, not a capability claim: each country has its own authorization and ethics route, timelines and site contracting practice, so sequencing is decided at the country strategy stage, not after the first submission is filed.

How does ISO 14155:2026 affect clinical monitoring?

ISO 14155:2026 reinforces the integration of risk management and data oversight into clinical investigation conduct. Monitoring should therefore be planned according to the risks of the investigation, the device, the procedures, the endpoints and the sites involved. The monitoring plan should define the appropriate combination of on-site and remote activities, source data review or verification where applicable, issue escalation and continuing oversight. The objective is not a uniform monitoring model across every study, but a monitoring approach proportionate to the investigation and capable of identifying material risks and data-quality issues. This page covers how the standard informs monitoring; for the delivery model itself see our medical device clinical monitoring services.

Regulatory position reviewed: 10 August 2026.

Next step

Planning an ISO 14155:2026 Medical Device Clinical Investigation?

Bring Eclevar in before protocol decisions, country assumptions or site selection choices become expensive to reverse. Our medical device clinical team can review your development stage, study design, geography, timelines and CRO scope, and translate them into an executable clinical investigation plan.

Discuss Your Study With Eclevar

Protocol or synopsis available? Share the device, indication, target geography, population and expected study timeline so the first discussion can focus on feasibility, execution risk and CRO scope.

Related reading

Reforming Clinical Evaluation of Medical Devices in Europe