EU Medical Device Regulation (MDR) Overview
The EU Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD) and the Directive on Active Implantable Devices (AIMDD), imposing stricter requirements for medical device manufacturers.
Key MDR changes include:
Unique Device Identification (UDI) implementation
Device reclassification based on risk, duration, and invasiveness
Enhanced documentation and clinical evidence requirements
Mandatory availability of a qualified regulatory expert (PRRC)
Increased oversight by Notified Bodies
EUROMED Authorized Services Kft helps manufacturers partner with EU-designated Notified Bodies for conformity assessment procedures. We guide you through the process and support with Technical Documentation and Quality Management System (QMS) evaluations.
Conformity Assessment Process
Initial consultation and project description
Detailed quote and conformity assessment plan
Application submission to Notified Body
Technical Documentation (TD) and QMS assessment
Corrective actions and audit responses
Certification decision by Notified Body
We offer guidance in line with MDR requirements and support in preparing all necessary documentation. Certification costs depend on company size, device complexity, and assessment needs.