Catheters, continence care, ureteral stents, slings, prostate devices and bladder control implants: Eclevar MedTech designs and runs the clinical evidence that EU MDR demands, with ISO 14155 investigations across Europe and a former Notified Body reviewer on the senior team. Coloplast is among our clients.
In the xShare and European CRO Federation (EUCROF) Open Call for Clinical Research, the top Platinum Award went to Milo Health, the technology platform behind Eclevar's evidence and forecasting work, presented at the EUCROF 2026 conference in Amsterdam.
Platinum Award · xShare Open Call for Clinical Research, organised by EUCROF and co-funded by the European Union. Amsterdam, 2 February 2026.
Whether you are launching a new implant, defending a legacy catheter line or answering a deficiency letter, scope the engagement to the problem in front of you.
ISO 14155 and MDR Annex XV investigations across France, the UK, Germany and beyond: feasibility, site selection, start up, monitoring and data management, with patient reported outcomes built into the protocol.
Clinical evaluation reports built against Notified Body assessment logic, and PMCF surveys designed for large, dispersed user populations: catheters, continence care and stoma adjacent products.
Slings, mesh and implantable urology devices face elevated reviewer scrutiny. A senior consultant, backed by a former Notified Body reviewer, rebuilds the failing element and drafts the response.
Three structural pressures define clinical evidence for urology devices in Europe today. Plan for them from the first protocol, not the first deficiency letter.
After the urogynaecological mesh controversies, reviewers expect long term safety data, complication and explant reporting, and rigorous state of the art benchmarking for slings, mesh and implantable urology devices. Assertion based equivalence rarely survives.
Catheters, stents and continence products with decades on the market often rely on usage history rather than structured clinical data. EU MDR does not accept market history as evidence: the gap must be closed with literature, registries and PMCF.
Continence, voiding function and quality of life are patient reported by nature. Protocols and PMCF instruments need validated outcome measures, and data systems that can collect them at scale from dispersed users, not just from hospital visits.
Intermittent and indwelling catheters, continence products and accessories: PMCF at user population scale, usability and quality of life endpoints.
Stents, guidewires, retrieval devices and lithotripsy: comparative literature strategy and registry based follow up.
The highest scrutiny category: long term safety architecture, explant and complication data, state of the art benchmarking.
Minimally invasive BPH treatments and prostatic implants: investigation design with validated symptom scores and durability endpoints.
Sacral and tibial nerve stimulation for overactive bladder: implant follow up, responder analysis and PMCF linkage to the CER.
Measurement and diagnostic systems: performance evidence, software documentation alignment and clinical evaluation.
Sponsors across continence care, renal, cardiovascular, dental and wound care rely on Eclevar for clinical investigations, clinical evaluation and PMCF.
