CER authoring, biological evaluation, PMCF strategy and ISO 13485 support for dental manufacturers under EU MDR and UK MDR, delivered by a practice whose lead spent 11 years assessing dental technical files inside Notified Bodies, in English and Japanese.
The top Platinum Award went to Milo Health, the trial forecasting technology developed by Eclevar, at the EUCROF 2026 conference. The same engine now prices and forecasts device evidence programmes against real European data.
Platinum Award, xShare Open Call for Clinical Research, organised by EUCROF and co-funded by the European Union. Amsterdam, 2 February 2026. Horizon Europe, Grant Agreement No. 101136734.
Three ways device sponsors typically reach us, each mapped to a dedicated capability.
Full CER authoring for dental devices Class IIa to IIb: structured literature searches, evidence appraisal, equivalence assessment and Notified Body calibrated reporting, held to your submission schedule.
Systematic gap analysis of your technical documentation against EU MDR Annex II and III, deficiency resolution and a phased remediation plan, before your Notified Body finds the gaps for you.
Biological evaluation under the ISO 10993 series led by a Doctor of Dental Surgery, PMCF strategy under Article 61 and MDCG 2020-7 designed for dental practices, and EU MDR training for your team.
Shofu is a leading Kyoto based dental manufacturer with a broad European portfolio of restorative materials, ceramics, instruments and CAD/CAM systems. Its EU MDR compliance programme requires periodic Clinical Evaluation Report production across multiple device families.
Eclevar provides periodic CER authoring strictly aligned to the Shofu Notified Body submission schedule, with literature searches, evidence appraisal and documentation calibrated to EU MDR Annex XIV and MEDDEV 2.7/1 Rev 4. Our practice lead communicates with Shofu regulatory teams directly in Japanese: no translation friction, no loss of technical nuance.
Reimbursement clinical trial, multi centre study in the UK.
ISO 14155 clinical investigations for autologous PRP systems.
MDR transition and legacy evidence gap bridging across multiple risk classes.
Clinical strategy and compliance support for advanced medical devices.
From restorative materials to complex implants, our regulatory strategy is tailored to the specific risk class of your dental portfolio.
Non-active instruments and basic dental tools requiring solid technical documentation.
Composites, ceramics, cements and CAD/CAM blocks managed under periodic CER updates.
Dental implants, abutments and alloys requiring rigorous clinical evidence and PMCF.
Advanced materials incorporating medicinal substances and high-risk applications.
ISO 10993 compliance specifically adapted for materials in the oral environment.
Notified Bodies are increasingly rejecting clinical evaluations for dental devices where equivalence is poorly argued or where PMCF relies on passive complaint data rather than active surveillance.
Transitioning from MDD to MDR requires a robust strategy. Missing long-term data creates gaps that regulators no longer accept, and biological evaluations must strictly follow ISO 10993 requirements for oral applications.
Your technical documentation deserves to be reviewed by experts who understand the nuances of dental applications.
Former senior reviewer at a Notified Body (TUV SUD). He challenges every design the way your reviewer will.
CERs, PMCF reports and submission documents built to Notified Body expectations.
Data management, biostatistics and the Milo platform behind our forecasts.
Pilote la réalisation des investigations cliniques et études PMCF en Europe. Qualification des sites, monitoring, TMF, ISO 14155:2020. Master Ingénierie de la Santé (Université Grenoble Alpes). Parcours : recherche clinique, cardiovasculaire, usability medical devices.
Your first contact for scoping calls, partnerships and sponsor relationships.
The Eclevar team, including our former Notified Body expert, on what clinical trials need to satisfy Notified Body review.
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Prof. Mark DaCosta, COO and former Notified Body expert, joins the CSI Frankfurt speaker panel on EU MDR and the introduction of new devices.
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Our award winning platform reads a protocol and returns three costed scenarios, swift, base and conservative, plus a recruitment forecast.
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Where European clinical evaluation is heading and what it changes for your CER and PMCF strategy.
How to architect PMCF surveys and registries that satisfy Notified Bodies without draining your budget.
Choosing between PMCF studies, registries and surveys for device portfolios.
Eclevar operates from Paris, London, Dublin and Tokyo, and delivers device evidence studies across France, the United Kingdom, Germany and the wider EU. Through our clients and partners, our evidence supports devices marketed in 160 countries.
Discuss your target countriesLook for dental specific Notified Body experience, command of MEDDEV 2.7/1 Rev 4 and the MDCG guidance, biological evaluation expertise for materials in the oral environment, a credible PMCF approach for dental practices, and the ability to hold a periodic CER schedule. Eclevar's dental practice is led by a former Notified Body dental assessor with 11 years inside Notified Bodies.
From Class I non active instruments through Class IIa restorative materials, Class IIb dental implants, abutments and alloys, to Class III materials incorporating medicinal substances. We do not take dental mandates for active devices, imaging systems or software as a medical device, and will direct you to partners for those needs.
Dr. Yumiko Kida, DDS, CMO and Head of Dental. A Doctor of Dental Surgery from Okayama University, she spent 11 years inside Notified Bodies as Technical Documentation Assessor at Intertek and Product Assessor at SGS, after introducing European and US dental materials to the Japanese market as Product Manager at Heraeus Kulzer and Dentsply.
Yes. Our practice lead is a native Japanese speaker with direct experience of Japanese regulators and of bringing dental devices to the Japan market, and Eclevar has an office in Tokyo. Japanese regulatory teams communicate directly in Japanese, with no translation friction.
Our team has assessed dental technical documentation from inside Notified Bodies, so we read a deficiency letter the way its author intended. We perform a gap analysis against EU MDR Annex II and III, rebuild the clinical evaluation and respond in the language and rigour reviewers expect.
PMCF plans under EU MDR Article 61 and MDCG 2020-7, designed for practical engagement by dental practices: survey instruments, literature surveillance protocols and PMCF evaluation reports that feed your PSUR and keep the CER current.
A free scoping call with our senior team: your device, your target countries, and the fastest compliant route to evidence.
Book a free scoping call