Specialist technical documentation review, clinical evaluation, and regulatory strategy for medical device manufacturers navigating EU MDR 2017/745. From Class I instruments to Class III implantable systems.
EU MDR 2017/745 has transformed technical documentation from a certification artifact into a living regulatory system. Notified Bodies no longer check whether documents exist. They assess whether the technical file is internally consistent, whether clinical evidence actually supports device claims, and whether post-market surveillance plans reflect genuine monitoring.
The most common failure mode is misalignment between sections — a clinical evaluation that claims equivalence with a device the risk management file treats as novel. These gaps are expensive to fix after submission.
Eclevar Medtech's approach is to review technical documentation as a Notified Body would, before it reaches one. We look for internal inconsistency, evidentiary gaps, and claims that cannot be sustained under scrutiny.
MDR-accredited Notified Bodies currently operating, down from 75 under MDD — creating massive certification bottlenecks.
New MDR applications submitted to Notified Bodies, highlighting the immense review backlog manufacturers face today.
Final MDR transition deadline for legacy Class IIb devices. Actions must be initiated immediately.
Every service Eclevar Medtech provides 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 assess internal consistency, identify evidentiary gaps, and produce a prioritized remediation plan.
Review and authoring of risk management files aligned to MDR GSPR. We verify that risk conclusions are consistent with clinical evidence and biological evaluation results.
Full CER authoring across all therapeutic verticals. Structured literature search, PICO-based appraisal, equivalence assessment, and reports calibrated to the reviewing Notified Body's expectations.
Biological evaluation plan and report authoring, covering biocompatibility assessment, chemical characterization, and toxicological risk assessment. Critical for implantables and dental materials.
PMCF plan design and PMCF evaluation report production. Annual PSUR authoring synthesizing post-market surveillance data, literature updates, vigilance, and risk-benefit conclusions.
EUDAMED actor and device registration support, UDI assignment, and Post-Market Surveillance plan authoring structured around your device category and available data sources.
Manufacturers with legacy CE-marked portfolios under MDD who must achieve MDR certification before deadlines. We fix structurally insufficient technical files.
Asian, US, or non-European manufacturers entering the EU market. We build the MDR documentation, manage Notified Body selection, and establish EU regulatory infrastructure.
Already CE-marked manufacturers who need a standing regulatory partner to manage annual PSUR, PMCF execution, and EUDAMED maintenance.
TAVI, stents, EP catheters, structural heart devices, pacemakers, and vascular grafts.
Joint replacement, spinal implants, fracture fixation, bone cements, and biomaterials.
Dental implants, restorative materials, orthodontics, bone substitutes, and CAD/CAM.
Advanced dressings, negative pressure, antimicrobial, and skin substitutes.
From initial contact to standing post-market partnership.
Portfolio review, classification assessment, NB relationship status, and transition timeline. Scoping note within five business days. No cost for initial assessment.
Systematic review against MDR requirements. Prioritised remediation plan with timelines, deliverable list, and resource estimate. Structured by section and urgency.
Technical file remediation, CER and biological evaluation authoring, PMCF plan, risk management review. Each deliverable reviewed internally before delivery.
Submission package preparation, NB query management, and technical call participation. Our background means we anticipate questions and resolve them efficiently.
Annual PSUR, PMCF execution, literature surveillance, EUDAMED maintenance, and QMS oversight. We function as your standing regulatory partner.
Whether you are in MDD-to-MDR transition, entering the European market for the first time, or managing ongoing post-market compliance obligations, Eclevar can scope your regulatory position within five business days.
Request a scoping call
