Eclevar Medtech provides expert EU MDR and UK MDR compliance support for dental device manufacturers. Our clinical strategy is built around a team that has assessed technical documentation from within Notified Bodies and delivered results on the ground across Europe, and in Japan.
CMO & Head of Dental
With over two decades in the medical device industry and Notified Bodies, Dr. Kida brings a rare dual perspective as a former dentist and seasoned Product Assessor. What makes her perspective irreplaceable is that she has reviewed the same categories of technical files that her clients are now producing ‒ from the other side of the table.
Dr. Kida also has extensive experience of Japanese regulators, having brought to the Japan market dental devices from global US and European manufacturers as Product Manager. She knows exactly what a reviewer looks for and what constitutes adequate clinical evidence for each dental device class.
Technical and clinical documentation assessment for 30+ dental devices and surgical instruments under MDD and EU MDR.
Technical file review for 20+ dental clients under MDD. Managed 400+ complaints and 70+ controlled documents under ISO 17021 and ISO 13485.
Introduced European and US dental materials to the Japanese market. Managed brand compliance, KOL networks, and regulatory approvals in Japan.
Eclevar Medtech navigates complex product portfolios for the most exacting dental manufacturers in the world.
Shofu is a leading Kyoto-based dental manufacturer with a broad European portfolio of restorative materials, ceramics, instruments, and CAD/CAM systems. Their EU MDR compliance program requires periodic Clinical Evaluation Report (CER) production across multiple device families.
Periodic CER authoring strictly aligned to the Shofu Notified Body submission schedule. We conduct literature searches and evidence appraisal, and calibrate documentation to EU MDR Annex XIV and MEDDEV 2.7/1 Rev 4.
Our Practice Lead provides native Japanese fluency to ensure Shofu regulatory teams communicate directly in Japanese. There is no translation friction and no loss of technical nuance during critical reviews.
Shofu is a leading Kyoto-based dental manufacturer with a broad European portfolio of restorative materials, ceramics, instruments, and CAD/CAM systems. Their EU MDR compliance programme requires periodic Clinical Evaluation Report (CER) production across multiple device families.
Eclevar Medtech provides periodic CER authoring strictly aligned to the Shofu Notified Body submission schedule. Documentation is calibrated to EU MDR Annex XIV and MEDDEV 2.7/1 Rev 4 requirements.
Our Practice Lead provides native Japanese fluency to optimise communication with Shofu regulatory teams. This eliminates translation friction and prevents the loss of technical nuance during critical document reviews.
Our firm provides six service areas, each defined precisely by verified expertise. We do not list services that we cannot deliver with direct experience.
Honest scope. Our dental practice covers technical documentation, Clinical Evaluation Reports (CER), biological evaluation, QMS support, PMCF strategy, and regulatory training. We also provide clinical study services where needed.
Eclevar Medtech provides full CER authoring for dental devices Class IIa to IIb. This includes structured literature searches, clinical evidence appraisal, equivalence assessment, and Notified Body calibrated reporting.
We perform a systematic review of your technical documentation against EU MDR Annex II and III. We identify gaps before your Notified Body does and deliver a phased remediation plan.
Evaluations are led by a Doctor of Dental Surgery who understands how alloys, resins, and ceramics interact within the oral environment. We structure biological evaluation plans and assess chemical characterisation data.
Our Post-Market Clinical Follow-up (PMCF) plans are designed for practical engagement by dental practices. We design survey instruments, literature surveillance protocols, and PMCF evaluation reports.
We provide internal audits, SOP development, complaint management review, and CAPA process support. These services are drawn from direct experience managing ISO 17021 standards at SGS.
Eclevar Medtech delivers structured regulatory training for dental manufacturer teams entering Europe. Training is available in English and Japanese, covering EU MDR classification and EUDAMED registration.
This scope is grounded in verified Notified Body assessment experience. Eclevar Medtech does not accept mandates outside of these specific categories.
| Class | Category | Examples | Key EU MDR Obligations |
|---|---|---|---|
| Class I | Non-active instruments. Examination and surgical tools. | Scalers, mirrors, excavators, burnishers, examination gloves, curing lights, and probes. | Declaration of Conformity, technical documentation, and self-assessment. |
| Class IIa | Restorative materials. Short-to-medium duration contact. | Composites, glass ionomer cements, impression materials, and bonding agents. | Notified Body conformity assessment, CER, PMCF plan, PMS, and PSUR. |
| Class IIb | Implants & high-risk. Implantable, long-term contact. | Dental implants, abutments, dental alloys, and non-animal bone substitutes. | Full Notified Body assessment, CER, SSCP, implant card, PMCF, and PSUR. |
| Class III | Highest-risk implantable. Animal-derived or drug-incorporating. | Resorbable bone cements and endodontic materials incorporating medicinal substances. | Full Notified Body QMS and technical documentation audit, clinical investigation data, and SSCP. |
Outside our dental scope. Eclevar Medtech does not provide services for active devices, imaging systems, SaMD within dental workflows, or clinical investigation management and site monitoring for dental trials. We will direct you to appropriate partners within our network for these specific needs.
Eclevar Medtech supports global leaders in the medical industry in managing their complex product portfolios with specialised regulatory expertise.
Nihon Kohden is a Japanese leader in medical equipment manufacturing. As part of the compliance process for their EEG-1200K system, the Eclevar Medtech team provided specialised expertise to transform complex regulatory challenges into clear and actionable solutions.
Eclevar Medtech provided in-depth support regarding the documentation preparation policy and applicable regulatory guidelines. We utilised our expertise to create documentation perfectly suited to the specific needs of the product.
We ensured seamless responsiveness and total flexibility for organising direct meetings. This approach allowed the teams to move forward efficiently, with total understanding and full satisfaction regarding the delivered content.
Eclevar Medtech provides a seamless transition from initial scoping to long-term post-market partnership.
We perform a comprehensive review of your device portfolio, documentation status, and Notified Body relationship. Eclevar Medtech provides a detailed scoping note including a compliance gap analysis and a phased remediation plan within five business days.
Our practitioners manage technical documentation remediation, CER and CEP authoring, biological evaluation review, and PMCF planning. Every deliverable undergoes a rigorous internal review process before final submission.
We facilitate submission package preparation, Notified Body query management, and participation in technical calls. Our background as former assessors allows us to anticipate regulatory concerns and proactively resolve potential roadblocks.
We provide ongoing PMCF execution, annual PSUR contributions, literature surveillance, and Quality Management System maintenance. Eclevar Medtech functions as your permanent regulatory and clinical partner.
Whether you are a European manufacturer navigating the EU MDR transition, an Asian or US company entering the European market, or a firm managing a complex dental portfolio, Eclevar Medtech will assess your specific requirements and provide an honest scope within five business days.
