MDR / IVDR — EU Medical Device Regulations
Technical Documentation, Clinical Evaluation and Conformity Assessment for EU 2017/745 and EU 2017/746.
Your Challenges
Technical Documentation
Annex II/III requirements — complete fulfilment and traceability
Clinical Evaluation
CER/PER creation, clinical data collection, PMCF plan development
Notified Body Process
Submission preparation, assessment management, CE marking
Our Approach
Classification & Route to Market
Device class determination, conformity assessment route planning, Notified Body selection.
Technical Documentation (Annex II/III)
Complete TD: Device Description, Risk Management, Clinical Evaluation, Performance Data.
Clinical Evaluation & PMCF
CER/PER per MEDDEV 2.7/1 Rev 4, Clinical Data Assessment, PMCF plan development.
Notified Body Submission & Review
Submission package preparation, review process management, audit support.
Software Support
Technical Documentation Management
Structured TD per Annex II/III with full traceability
Clinical Data Repository
Literature search, clinical investigation data, PMCF centrally organized
GSPR Compliance Matrix
General Safety & Performance Requirements systematically demonstrated
Risk Management Integration
ISO 14971 risk files linked with TD
Post-Market Surveillance
PMS plan, PSUR, trend reports automated
Change Management
Significant changes identification, Notified Body notifications managed
Typical Project Timeline
Gap Analysis & Route Planning
Classification, existing documentation review, roadmap
TD & CER Creation
Complete Technical Documentation, Clinical Evaluation Report, evidence collection
NB Submission & Review
Package submission, response to questions, audit preparation
CE Marking
Successful conformity assessment and market access
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