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EU MDR Gap Analysis and Assessment for CE Marking

The new European Union Medical Device Regulation 2017/745 (EU MDR) has replaced the Directives and raises the compliance bar for manufacturers. If you’ve extended your CE certificate under the Directives, this is the time for action! Expect auditors to be very busy in 2023 and 2024 as these certificates expire.

Even for seasoned regulatory professionals, understanding the impact of EU MDR 2017/745 has not been easy. We know, because we have trained and advised dozens of medical device companies and their employees on the EU MDR.

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 Quality Plan that documents necessary tasks, resources, and timelines to address identified gaps.

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 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