Specialized review of technical documentation, clinical evaluation, and regulatory strategy for medical device manufacturers under the EU MDR 2017/745. From Class I instrumentation to Class III implants.
EU MDR 2017/745 has transformed technical documentation from a simple certification deliverable into a living regulatory system. Notified Bodies no longer just check for the existence of documents. They evaluate the internal consistency of the file, verifying whether clinical evidence truly supports the device's claims and if surveillance plans reflect authentic monitoring.
The most common failure mode is misalignment between sections—for example, a clinical evaluation claiming equivalence to a device that the risk management file treats as novel. These gaps are extremely costly to correct after submission.
Eclevar Medtech's approach is to examine your technical documentation just as a Notified Body would, before it reaches them. We hunt for internal inconsistencies, evidence gaps, and claims that would not withstand close scrutiny.
MDR-accredited Notified Bodies currently operational, compared to 75 under the MDD—creating massive bottlenecks for certification.
New MDR applications submitted to Notified Bodies, highlighting the immense review backlog manufacturers face today.
Final MDR transition deadline for Class IIb legacy devices. Compliance actions must be initiated immediately.
Eclevar Medtech's full suite of services under EU MDR, UK MDR, and related frameworks — organized by documentation, clinical evidence, and quality systems.
Systematic review of your complete technical documentation against current MDR requirements. We evaluate internal consistency, identify evidence gaps, and produce a prioritized remediation plan.
Review and authoring of risk management files aligned with MDR GSPRs. We ensure risk conclusions are consistent with clinical evidence and biological evaluation results.
Full CER authoring across all therapeutic areas. Structured literature search, PICO-based appraisal, equivalence analysis, and reports calibrated to Notified Body expectations.
Authoring of the Biological Evaluation Plan (BEP) and Report (BER), including biocompatibility assessment, chemical characterization, and toxicological risk assessment. Crucial for implants and dental materials.
PMCF plan design and PMCF evaluation report production. Annual authoring of the Periodic Safety Update Report (PSUR) synthesizing post-market surveillance data, literature updates, and benefit-risk conclusions.
Support for actor and device registration in EUDAMED, UDI assignment, and authoring of the Post-Market Surveillance (PMS) plan structured according to your device category.
Manufacturers with CE-marked portfolios under the MDD needing to achieve MDR certification before deadlines. We remediate structurally insufficient technical files.
Asian, American, or non-EU manufacturers entering the European market. We build MDR documentation, manage NB selection, and establish regulatory infrastructure.
MDR-certified manufacturers requiring an ongoing regulatory partner to handle annual PSURs, PMCF execution, and EUDAMED maintenance.
TAVI, stents, EP catheters, structural heart devices, and pacemakers.
Joint replacement, spinal implants, fixation systems, and biomaterials.
Dental implants, restorative materials, orthodontics, and CAD/CAM systems.
Advanced dressings, negative pressure therapy, and skin substitutes.
From initial contact to permanent post-market partnership.
Review of your device portfolio, classification assessment, status of Notified Body (NB) relations, and transition timeline. A scoping brief is provided within five business days. Initial assessment is free of charge.
Systematic review of your documentation against EU MDR 2017/745 requirements. Establishment of a prioritized remediation plan by section and urgency, including a deliverables list and resource estimation.
Remediation of the Technical File, CER authoring, biological evaluation (ISO 10993), PMCF plan, and risk management review. Every document undergoes a rigorous internal review before delivery.
Preparation of the submission package, management of NB queries, and participation in technical calls. Our expertise allows us to anticipate evaluator requests and respond effectively.
Annual authoring of the PSUR, PMCF execution, literature monitoring, EUDAMED maintenance, and QMS supervision. We act as your permanent external regulatory department.
Whether you are transitioning from MDD to MDR, entering the European market for the first time, or managing complex post-market obligations, Eclevar assesses your regulatory status within five business days.
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