2800 Patton Road | Roseville, MN 55113

EU MDR Consulting

The transition period for the new EU Medical Device Regulation (MDR) is quickly approaching, is your company in compliance?

On May 26, 2021, the new EU MDR changes will become mandatory and all requirements enforced. Fang Consulting can make sure you are fully equipped and in compliance with the new EU MDR regulations.

The Fang Consulting team are experts on how the new EU MDR regulations will change current medical device processes and requirements. From structuring a clear timeline to conducting a strategic gap analysis to providing EU MDR training for continuous progress, we ensure your implementation process will meet the deadline with the specialties necessary to accurately advise the transition.

Our staff provides EU MDR guidance at each step of the way so your company transitions efficiently and successfully.

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Our EU MDR Services

Impact Assessment

  • Medical device classification review
  • Analyze product documentation current-state vs future-state

Design Dossier & Tech File Gap Assessment

  • Outline specific documentation changes between EU MDD and EU MDR regulations for your products

Gap Assessment of Key Chemical/Material Restrictions (Such as those found in REACH, RoHS, BPR, & CLP)

  • Carcinogens
  • Mutagens
  • Reproductive Toxins
  • Endocrine Disruptors

Quality System Gap Assessment

Mock EU MDR Audit

Gap Response Plan

Notified Body Submission/Response

Post-Market Surveillance of Medical Devices

  • Vigilance reporting
  • Trend reporting
  • EUDAMED database updates

Clinical Evaluation Reports (CER)

  • MedDev 2.7.1 Rev. 4
  • MDR Updating

Training

  • On-site EU MDR training and overview
  • Requirements
  • Timelines
  • Customer/class-specific requirements
  • Clinical evidence strategies
  • Implementation of best practice

On May 26, 2021, the new EU MDR goes into effect, are you in compliance?