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

Physician’s hand holding FDA approval sign

March 14, 2022

What is FDA Premarket Approval?

At Sterling, we have helped bring hundreds of medical devices to market. While the products vary, the questions posed by the companies developing them are often the same. They want to know what it...
Read More >
View More Blogs

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.
Read More >
View More Videos
Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
Read More >
View More Case Studies

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis