A specialist dental device CRO in Europe: periodic CER authoring, biological evaluation under ISO 10993, PMCF strategy and CE marking for dental implants and restorative materials, with clinical evidence designed the way Notified Bodies expect to read it, from the first protocol version, in English and Japanese.
Platinum Award 2026
Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Manufacturers choose Eclevar as their specialist CRO for dental devices and EU MDR compliance. Read all client success stories.
Dr Mark DaCosta is a former TÜV SÜD Notified Body assessor who has certified more than 400 devices in Europe. As COO and CMO he sets the standard the whole team works to: clinical evidence designed exactly the way reviewers expect to read it. The dental device practice itself is led by a former Notified Body dental assessor with 11 years inside Notified Bodies and native Japanese delivery, so dental technical files, clinical evaluation reports and long-term PMCF architectures translate into approvals from the very first version.
Direct regulatory reading, EU MDR Annex XIV alignment and MDCG guidance from a former Notified Body dental assessor.
Full CER authoring for dental devices Class IIa to IIb: literature searches, evidence appraisal, equivalence assessment and reporting under MEDDEV 2.7/1 Rev 4 and MDCG 2020-13.
Biological evaluation led by a Doctor of Dental Surgery, specifically adapted to materials in the oral environment and their contact duration.
PMCF Plan drafting, survey instruments, literature surveillance and PMCF Evaluation Reports under Article 61 and MDCG 2020-7, feeding your PSUR.
Gap analysis against EU MDR Annex II and III, Notified Body deficiency resolution and phased remediation for CE marking of dental implants.
Offices in Paris, London, Dublin and Tokyo, delivery across the EU and native Japanese communication for Japanese dental manufacturers.
From Class I instruments and restorative materials to Class IIb dental implants, abutments and alloys, our regulatory strategy is tailored to the specific risk class of your dental portfolio. Biological evaluation is adapted to the oral environment, and the clinical evaluation is built to the higher equivalence bar that Notified Bodies now apply to dental devices under EU MDR.
Periodic CER authoring 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, communicated directly in Japanese with no translation friction.
Clinical evaluation and PMCF strategy for a dental implant range: equivalence held to the higher EU MDR bar, biological evaluation for the oral environment and a PMCF plan that keeps the evidence current for re-certification.
Gap analysis of the technical documentation against EU MDR Annex II and III, rebuild of the clinical evaluation and a deficiency response written in the language and rigour reviewers expect, read the way its author intended.
Biological evaluation under the ISO 10993 series led by a Doctor of Dental Surgery, combining a chemical characterisation strategy with literature review across multiple material variants to demonstrate safety in the oral cavity.
Former TÜV SÜD assessor. 400+ devices certified; he challenges every design the way your reviewer will.
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Former TÜV SÜD assessor. Builds PMCF programmes, registries and CERs designed to pass strict audits.
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Clinical evaluation and CER from protocol through Notified Body responses.
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30 years in biometrics; architect of the MILO EDC platform (21 CFR Part 11).
LinkedInWhitepapers, 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, dental devices included.
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. »
Look 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 combines all of these, with a former Notified Body dental assessor with 11 years inside Notified Bodies in the team.
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.
Yes. Eclevar delivers periodic CER authoring for dental devices under MEDDEV 2.7/1 Rev 4 and MDCG 2020-13, with structured literature searches, evidence appraisal, equivalence assessment and Notified Body calibrated reporting for CE marking of dental implants and restorative materials.
Biological evaluation under the ISO 10993 series, led by a Doctor of Dental Surgery and specifically adapted to materials in the oral environment, so safety is demonstrated for the contact duration and tissue types dental reviewers expect.
Eclevar operates from Paris, London, Dublin and Tokyo, and delivers dental device evidence across France, Germany, the United Kingdom, Ireland and the wider EU. Through clients and partners, our evidence supports devices marketed in 160 countries, with native Japanese delivery for Japanese manufacturers.
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.
Talk to our specialists about your dental implant, restorative material or wider portfolio and the fastest compliant route to Notified Body ready clinical evidence. Contact the team or explore our implant and cardiovascular practices.
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