CE Premarket Approval

You want to get your product to market as quickly as possible, but to do so, you need to ensure you are complying with the strict regulations mandated across the medical device industry. Failing to do so can put your business—and more importantly, your end-users—at risk. Navigating the murky waters of the European Union’s (EU) conformité européenne (CE) Mark regulatory requirements, and knowing which ones your device is subject to, can be daunting, even for the most established medical device manufacturers. This is especially true with the EU’s transition from the Medical Device Regulation (MDR) system to the In Vitro Diagnostic Regulation (IVDR) system.

Sterling can help.

Before bringing a medical device to market in the EU and other parts of the world that follow CE Mark regulation, it is essential to determine applicable regulatory requirements it must adhere to in order to ensure patient and user safety. With Sterling’s regulatory strategy support, we offer services to help you identify and address key CE Mark requirements for your device including:

  • Overall EU regulatory strategy support
  • EU MDR gap analysis and assessment for CE Mark
  • CE Mark documentation support, specifically:
    • EU MDR to IVDR submission documentation gap analysis
    • Transitioning from U.S. Food and Drug Administration (FDA) submission to CE Mark submission
    • Transitioning from Medical Devices Directive (MDD) submission to MDR submission
    • Other submissions to MDR submission
    • EU MDR/IVDR documentation compilation and submission
    • EU MDR/IVDR documentation remediation
  • Notified body communication support services
  • MDR clinical evaluation report support services, specifically:
    • EU MDR CER gap analysis
      • Transitioning from FDA submission to CE Mark submission
      • Transitioning from MDD submission to IVDR submission
      • Other submissions to IVDR submission
    • EU MDR CER development and transition support
    • EU MDR CER remediation
  • IVDR Performance Evaluation Report (PER) support services, specifically:
    • EU IVDR PER gap analysis
    • EU IVDR PER development and transition support
    • EU IVDR PER remediation

At Sterling, we understand the legal requirements for marketing your product in the EU. When it comes to the increasingly complex world of regulatory submissions, we’ve got you covered.

Resources

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February 24, 2018

Gap Analysis

Bridging the Gap between Good to Even Greater All medical devices and software are required to undergo a series of mandatory safety testing in order to satisfy standards such as the FDA Quality...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
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