Pre-CE-mark or post-market, exploratory or confirmatory, every clinical investigation answers to EU MDR 2017/745 and ISO 14155:2026. Eclevar designs and runs the whole study in-house across seven countries, with former Notified Body reviewers shaping the Clinical Investigation Plan from version 1.
In-house delivery · 7 countries
Study design, Article 62 submissions, monitoring and data management, all in-house on the MILO Studio platform that won the Platinum Award at the xShare & EUCROF 2026 Open Call.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders across cardiovascular, orthopaedics, wound care and more choose Eclevar. Read all client success stories.
A clinical investigation is a systematic study in human subjects that assesses the safety or clinical performance of a medical device, planned and reported to EU MDR 2017/745 and ISO 14155:2026.
Every investigation starts from a Clinical Investigation Plan (CIP) and an Investigator's Brochure (IB), and requires a favourable ethics committee opinion. For pre-market studies, EU MDR Article 62 also requires authorisation from the national competent authority before the first subject is enrolled, supported by the risk management file, insurance and informed consent forms. This is run as an in-house medical device CRO service, not a subcontracted one.
The first fork is timing. A pre-CE-mark investigation studies a device that is not yet CE marked to build the clinical evidence for conformity assessment, and under MDR it is always interventional. A post-market investigation studies a CE-marked device already in use, usually as part of post-market clinical follow-up, and can be observational or interventional depending on subject burden.
The second fork is intent. An exploratory investigation generates hypotheses; a confirmatory pivotal investigation tests a pre-specified endpoint. Getting both forks right in the CIP is what makes the resulting clinical evaluation report defensible in front of a Notified Body.
Eclevar's model brings the regulatory perspective inside the CRO, eliminating the gap between what manufacturers submit and what assessors expect. Dr Mark DaCosta, COO and former TÜV SÜD reviewer, and Dr Nikhil Khadabadi, CMO for orthopaedics and spine and also a former TÜV SÜD senior reviewer, lead a team that designs clinical evidence exactly the way Notified Bodies expect to read it, from the first protocol version.
The single decision that shapes every submission is whether your device is CE marked yet, and whether subjects carry extra burden. Get the classification wrong and the wrong MDR pathway follows it all the way to the Notified Body.
ISO 14155:2026 maps a device through a pilot stage that generates hypotheses and a pivotal stage that confirms them. We build the right study for each stage, and the CIP that lets a Notified Body follow the logic.
The first evaluation of a device in humans for a defined indication, an exploratory pilot study that establishes initial safety before any wider use.
A limited exploratory investigation of an early device concept, before the design is finalised, to gather insight that guides further development.
A preliminary safety and performance assessment of a near-final design, still exploratory, sizing and de-risking the pivotal study to come.
The main confirmatory study, with primary endpoint hypotheses pre-specified in the CIP, a larger population and a rigorous, controlled design.
Exploratory investigations generate hypotheses with no pre-set primary endpoint; confirmatory investigations state and test them under pre-planned statistics.
After CE marking, structured PMCF studies confirm long-term safety and performance under Articles 74 and 82.
One accountable team covers every stage of the clinical investigation lifecycle, so nothing is lost between a protocol, a competent authority submission and a Notified Body review.
Regulatory affairs and clinical strategy to classify the study, then competent authority and ethics submissions with the full Article 62 dossier.
Exploratory or confirmatory design, sample sizing and the Clinical Investigation Plan and Investigator's Brochure, written to ISO 14155 from version 1.
Feasibility and site selection and study initiation across our seven-country network of investigators.
On-site, remote and risk-based clinical monitoring by employed CRAs, protecting subject safety and data integrity throughout.
100% in-house clinical data management and EDC on MILO Studio: eCRF design, DMP and DVP built natively for EU MDR.
Post-market investigations and registry-based real world evidence that keep a CE certificate valid after launch.
A manufacturer with a non-CE-marked device needed to move from an early feasibility signal to a pivotal, confirmatory investigation without losing time at the competent authority. Eclevar classified the study correctly as a pre-CE-mark interventional investigation under Article 62, wrote the Clinical Investigation Plan and Investigator's Brochure to ISO 14155, and assembled the full submission dossier, risk file, insurance, informed consent and ethics documentation, for national authorisation.
Pre-specified endpoints and statistics were locked in the CIP before enrolment, monitoring and centralised review ran on MILO Studio, and the resulting evidence fed directly into the clinical evaluation report for conformity assessment, with a post-market plan already mapped.
Outcome: a clean pathway from feasibility to pivotal, a competent authority submission accepted first time, and clinical evidence structured the way a Notified Body expects to read it.
Former Notified Body reviewers from TÜV SÜD. We know what fails conformity assessment and design investigations to avoid it.
Clinical ops, writing and data management. One point of accountability, no handoff fragmentation.
Proprietary EDC built natively for EU MDR, with Annex XIV mapping and AI eCRF generation.
Paris, London, Tokyo and Pune. In-house CRAs in seven countries, not a network of subcontractors.
Platinum Award winner, EUCROF 2026, ranked first for clinical innovation and data strategy.
ISO 13485 certified. Every investigation structured for TMF completeness and Notified Body inspection readiness.
A network of employed CRAs and project leads, not subcontractors, gives sponsors consistent quality and one accountable team across the EU, the UK and Japan corridors.
Whitepapers, client testimonials and publications produced by our teams and partners (BSI, TÜV SÜD, RegenLab).
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, relevant to any high risk device programme.
Eclevar manages RegenLab's PMCF programme on chronic wound devices. This is a randomized study of 160 patients across 14 sites in 5 EU countries, covering both diabetic foot ulcer (DFU) and venous leg ulcer (VLU) indications. The partnership combines Eclevar's ISO 14155 clinical expertise with the Milo Studio platform to deliver post-market clinical follow-up evidence that supports both Notified Body scrutiny and reimbursement endpoints, from protocol design through to final study report.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
A clinical investigation is a systematic study in human subjects that assesses the safety or performance of a medical device. Under EU MDR 2017/745 and ISO 14155:2026 it is planned in a Clinical Investigation Plan, requires an ethics committee opinion and, for pre-market studies under Article 62, authorisation from the national competent authority before the first subject is enrolled.
An exploratory investigation generates hypotheses to be confirmed later and has no pre-specified primary endpoint; it covers pilot-stage work such as first-in-human, early feasibility and traditional feasibility studies. A confirmatory investigation is an adequately controlled pivotal study whose primary endpoint hypotheses and statistical analysis are stated in the Clinical Investigation Plan before it starts, designed to demonstrate safety and effectiveness.
A pre-CE-mark clinical investigation studies a device that is not yet CE marked, to generate the clinical evidence needed for conformity assessment. Under EU MDR it is always considered interventional and follows Article 62, requiring a full submission to the competent authority: Clinical Investigation Plan, Investigator's Brochure, risk management file, insurance, informed consent and ethics approval.
A post-market clinical investigation is conducted after a device is CE marked and on the market, typically as part of post-market clinical follow-up. Depending on whether subjects carry additional burden or the device is used outside its intended purpose, it may be observational or follow the stricter interventional pathway under Articles 74 and 82 of EU MDR.
ISO 14155:2026 describes a pilot stage and a pivotal stage. The pilot stage includes first-in-human, early feasibility and traditional feasibility studies that assess a device before its design is final. The pivotal stage is the main confirmatory study, using a larger population and a rigorous design to demonstrate the device's safety and effectiveness for its intended purpose.
Eclevar runs the full investigation lifecycle in-house across seven countries, to ISO 14155 and EU MDR from the first protocol version: study design, Article 62 competent authority and ethics submissions, feasibility and site selection, monitoring, and clinical data management on MILO Studio. Former Notified Body reviewers shape the Clinical Investigation Plan and reporting so the evidence is ready for conformity assessment. Talk to our medical device CRO team to scope your study.
Talk to our specialists about classifying your study, your Article 62 submission and a Clinical Investigation Plan built to ISO 14155 from day one.
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