Clinical Evaluation Reports

Medical staff in scrubs holding a clipboardAll medical devices sold in the EU must have a Clinical Evaluation Report (CER) as part of its technical documentation to satisfy the new EU Medical Device Regulation (MDR) requirements. A comprehensive analysis of pre- and post-market data relevant to a medical device, a Clinical Evaluation Report demonstrates that your device achieves its intended purpose without exposing users and patients to further risk.

At Sterling Medical Devices, we will prepare your Clinical Evaluation Report to establish conformity to the essential requirements, benefit and risk profile, post-market requirements, and frequency of updates. The report offers a summary of the findings, including the clinical literature review for device safety and performance, the literature review protocol, and the identification, appraisal, and analysis of the literature to substantiate the clinical need, device safety, and performance.

More specifically, the report will include: 

  • General information, including the device and manufacturer’s name
  • Physical and technical device description and intended use
  • Intended therapeutic or diagnostic claims
  • Clinical evaluation and data types
  • Summary of clinical data and review
  • The analysis used to assess the safety and performance, relevance, and accuracy of the literature
  • Conclusions about safety and performance

In addition to the report itself, we also offer the following: 

Assessment: We will conduct an assessment of the requirements of the MDR as they relate to your product to ensure it satisfies the requirements of the new European MDR. 

CER Assessment: We can also conduct an assessment of a device or family of products, help prioritize risks, and make recommendations on how to mitigate those risks. Note, the product classification may have changed under the new EU MDR, which may make it more difficult to maintain compliance.

Clinical Evaluation Plan: We will develop a Clinical Evaluation Plan (CEP) that outlines the requirements for device equivalency, data sources (literature or clinical investigations), post-market surveillance, and qualified evaluators as recommended.

Resources

September 1, 2021

How Long Does it Take the FDA to Approve a Medical Device?

According to research, time-to-market is a primary competitive driver in the medical device industry, second only to innovation.* You can’t start making money until you get FDA approval for your...
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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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people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

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....
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