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Medical Device CE Marking Certification Consulting for Europe

Before you can sell medical devices in Europe, you must first obtain CE Marking certification, more commonly referred to as the CE Mark. The path to CE Marking approval involves compliance with the current Medical Devices Directive (MDD) or the new European Medical Device Regulation (MDR), which takes effect on May 26, 2021. Whether you are introducing an entirely new device into the EU market or you need assistance transitioning an existing medical device with CE Marking certification, Oriel STAT A MATRIX can help.

Gap assessment examines your existing documentation to determine your readiness for CE Marking submission under the EU MDR

If you currently have FDA 510(k) clearance and want to pursue European CE Marking certification, we can examine your current technical documentation to determine what is needed before pursuing CE Marking certification for your device. Our comprehensive audit will look at your device history file, risk procedures, clinical data, testing reports, postmarket surveillance, labeling, and much more, providing you with a clear picture of what needs to be done. Oriel STAT A MATRIX can then help you fill the missing gaps in your existing documentation as needed to support CE Marking submission.

Transitioning existing medical devices with CE Marking under the MDD to the EU MDR

The new EU MDR will impose new requirements on manufacturers to demonstrate the safety and efficacy of their devices. A sizeable percentage of devices that currently have CE Marking certification under the Medical Devices Directive (MDD) do not have adequate supporting documentation to meet the requirements of the EU MDR. Oriel STAT A MATRIX consultants can examine your existing Technical File or Design Dossier and prepare a comprehensive report of shortfalls. Common areas we address for clients include clinical literature reviews, risk procedures, postmarket surveillance, Economic Operator agreements, and product life-cycle management.

Our CE Marking certification support for medical devices includes:

  • Determining the classification and regulatory pathway for your device.
  • Performing a gap assessment of your existing technical documentation.
  • Compiling your documentation – including your Clinical Evaluation Report and risk assessment – in support of a new CE Marking certification.
  • Assisting with MDD to EU MDR CE Marking transition strategy for existing device portfolios.
  • Evaluating or implementing an ISO 13485-compliant quality management system.
  • Preparing for the Notified Body inspection of your quality system.

Contact us today to learn how we can help you with European CE Marking certification for your medical device.

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