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EU MDR Gap Analysis and Assessment for MDD to MDR Transition

The 2017 publication of the new European Union Medical Device Regulation 2017/745 (EU MDR) introduced major compliance headaches for manufacturers.

Even for seasoned regulatory professionals, understanding the impact of EU MDR 2017/745 is not easy. We know, because we have trained and advised dozens of medical device companies and their employees on the EU MDR. This experience has given us a very good sense of the challenges ahead.

While the changes seem daunting, a critical first step is to understand your current level of compliance with the regulation. We can help. An Oriel STAT A MATRIX EU MDR readiness audit – which can be targeted or comprehensive and conducted onsite or a remote audit – provides the clarity you need. The resulting output is an EU MDR Transition Action Plan that documents necessary tasks, resources, and timelines to address identified gaps.

See how we helped a multinational device company get its facilities ready for MDR.

Our gap assessment of your compliance with EU MDR 2017/745 includes:

  • Classification of current device(s) and whether it has changed
  • Robustness of technical documentation files and linkage to design history files
  • Clinical evaluation reports (CER) and literature reviews
  • Risk management files and procedures
  • Status of existing testing to current standards
  • Postmarket surveillance processes
  • Economic operator agreements
  • Procedures for managing your supply and distribution chains
  • Product life-cycle management
  • Labeling changes that may be required
  • UDI compliance needs

We can help you tackle areas in need of immediate attention.

Once gaps have been identified, we can help you close them one at a time, focusing on the areas that pose the greatest risk and impact on compliance. Our team has extensive hands-on experience in assisting medical device companies, and this experience covers a wide variety of device categories. We understand the challenges you are facing and can assist you in getting to a state of readiness quickly.

Let us help turbocharge your EU MDR compliance efforts. Contact us today about conducting an MDR gap analysis.

Get answers right now. Call 1.800.472.6477