Enerxen

Enerxen
Enerxen

EUMDR

Regulatory Framework

As outlined on the European Commission website, EU MDR regulatory framework for medical devices

  • Stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
  • The reinforcement of the criteria for designation and processes for oversight of Notified Bodies
  • The inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations
  • The introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance
  • Improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification
  • The introduction of an “implant card” containing information about implanted medical devices for a patient
  • The reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
  • The strengthening of post-market surveillance requirements for manufacturers
  • Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance”

Our Capabilities:

Enerxen Consulting will deliver, related to the strengthening of post-market surveillance (PMS) requirements for manufacturers and the reinforcement of the rules on clinical evidence (CER):

  • PMSP: Post market surveillance Plans, PSUR: Periodic Safety Update Report, PMSR: Post market surveillance reports and CER: Clinical Evaluation Reports
  • PMSP/PSUR/PMSR and CER orientation training courses and practical classroom instruction on preparation of PMSP/PSUR/PMSR and CER
  • Work packages include technical documentation preparation of PMS/CER, preparation of technical File submission for notified bodies

Enerxen is an experienced, proven, one stop medical device system engineering company, successfully supporting businesses to roadmap and execution of EU MDR PMS and CER implementation.