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EU MDD to MDR Gap Analysis for Medical Device CE Marking

The EU Medical Device Regulation 2017/745 (EU MDR) replaces the Medical Devices Directives (MDD and AIMDD) and raises the compliance bar for manufacturers. If you’ve extended your MDD CE certificate, this is the time to get out in front of the crush of other medical device manufacturers that will be competing for Notified Body attention just before the deadlines.



Let Our Team Answer These Key Questions for You…

  • When do we need to be MDR compliant?
  • Can we make changes to our device in the meantime?
  • How close are we to being MDR compliant now?
  • What major differences exist between the MDD and MDR?

Have You Assessed Your Readiness to Transition from MDD to MDR?

With an interconnected quagmire of regulations and guidance documents, even seasoned regulatory professionals struggle to interpret the EU MDR. We know, because we have trained and advised hundreds of medical device companies making the transition from MDD to MDR.

A critical first step is to understand your current level of compliance with the MDR. Our MDR readiness audit – which can be targeted or comprehensive – provides the clarity you need. We will assess all aspects of your current quality management system, existing technical documentation, and regulatory compliance efforts. We will document the tasks, resources, and timelines needed to address identified gaps.

We Evaluate the Following as Part of Our EU MDD-to-MDR Gap Assessment:

  • Current level of compliance with MDR General Safety and Performance Requirements
  • Classification of current medical device(s) under the MDR
  • Robustness of your CE technical documentation files, including links to risk management, postmarket, design, and other processes
  • Depth of clinical evaluation reports (CER) and literature reviews
  • Risk management files and compliance with EN ISO 14971:2019+A11:2021
  • Status of existing testing to current standards
  • Postmarket surveillance (PMS), including trending and adverse event reporting
  • Economic operator (importers, authorized representative) agreements
  • Procedures for managing your supply and distribution chain
  • Product life-cycle management
  • Labeling changes and Unique Device Identification (UDI) compliance
  • Overlap of MDR requirements with ISO 13485
  • AR change support (if needed)
  • Support before and during Notified Body audits

Plugging the Gaps So You Can Maintain CE Marking for Your Medical Devices

Once MDR gaps have been identified, we can help you systematically close them, focusing on the areas that pose the greatest risk first. 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 MDR readiness quickly. Let us help turbocharge your EU MDR compliance efforts.

We're Ready to Help

Don’t get caught flat-footed at the last minute. Contact us today about conducting an MDD to MDR gap analysis, and let us put you on the path to compliance with the European Medical Device Regulation.

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Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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