Tele: 561.316.3330
Breaking Medical Device News

Monday, September 20, 2021

MEDICAL DEVICE NEWS MAGAZINE

A DIGITAL PUBLICATION FOR THE PRACTICING MEDICAL SPECIALIST, INDUSTRY EXECUTIVE AND INVESTOR
HomeWriting a Clinical Evaluation Report: 5 Quick and Intelligent Tips

Writing a Clinical Evaluation Report: 5 Quick and Intelligent Tips

January 25, 2020

Writing a Clinical Evaluation Report
Writing a Clinical Evaluation Report: CERtips

“Writing a clinical evaluation report: Sophie Laurenson, healthcare and technology innovator on Kolabtree, shares 5 tips for writing a clinical evaluation report and defining a CER strategy.”

The EU MDR has significantly impacted the way medical devices are regulated in Europe. As part of regulatory compliance, medical device manufacturers need to create and maintain a Clinical Evaluation Report (CER), a document essential for CE Marking. Here are expert tips on what to take into account to define a robust CER strategy.

1. Define a CER protocol and strategy

Identify the Essential Requirements (Safety and Performance Requirements in the MDR) that need to be supported by clinical evidence. Define metrics relative to performance, safety and risk/benefit endpoints.

2. Demonstrate equivalence

Equivalence is determined based on the comparison between a medical device and other pre-existing, similar CE-marked devices. The demonstration of equivalence is evaluated on relevant parameters that are defined by the manufacturer. The rationale for equivalence must be fully explained in the CER. The criteria for equivalence have become complex and stringent, with stronger connections to the Essential Requirements. It is critical to avoid the common mistake of selecting equivalent devices that are not relevant to your product. Documented data must be identified and analyzed for each equivalent device and for the differences between devices.

3. Evaluate literature review data

If equivalency can be demonstrated adequately, clinical data extracted from the literature on previous studies is a valuable tool in compiling a CER. However, it is critical that literature surveys are conducted in a systematic process:

  • Prepare a comprehensive protocol for the literature review,
    • Define inputs and parameters such as databases, search terms and exclusion criteria (languages, study type / design, study setting, endpoints),
    • Define the required safety and performance criteria based on the equivalent products and risk analysis,
    • Systematically gather relevant articles from different data sources,
    • Analyze the data using an objective method such as a framework and using multiple reviewers, and,
    • Document conclusions of the literature evaluation for inclusion in the CER document.

4. Determine the requirement for clinical investigation

The requirement for a clinical investigation is determined by the risk profile of the device. High risk and Class III devices must be subject to a clinical investigation. Novelty is also a determining factor, and devices based on innovative technologies or for a new intended use require clinical investigation. The available clinical evidence must address all the pertinent ERs. This can be ensured by sharing the Clinical Investigational Plan (CIP) with the relevant NB prior to implementation.

5. Monitor post-market activities

Under the MDR, PMS activities must be adequately planned and documented in the CER. The processes for evaluating ongoing clinical data and updating CERs must also be documented. To ensure that the CER remains relevant throughout the product life cycle, it must be updated regularly through a documented process. This includes evaluating the data and weighing the relevance of all equivalent devices. If you need help with writing a CER, it’s worth hiring a freelance Clinical Evaluation Report writer who can help you prepare and maintain a robust CER that meets all regulatory requirements.

Author bio:
Sophie Laurenson BSc. (Hons), Ph.D. (Cantab) has over 17 years of professional experience in healthcare, in both industry and academia. She consults on Kolabtree for medtech startups and SMBs. She previously worked in R&D functions at Abbott Laboratories in the United Kingdom, Germany, and Switzerland. She has experience in academic spin-outs and is the Founder and Managing Director of a health technology start-up specializing in emerging markets. Her areas of expertise include medical technology, digital health, and healthcare delivery technology. She is an expert on the subject of writing a clinical evaluation report. Another article of interest for device companies can be found here.

 

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Mark Foster Joins Xenocor BOD

Foster is a versatile and visionary C-Suite executive who brings 20 years of general management and leadership experience from both venture-backed growth-stage organizations and world-class medical device companies

Hinge Health Acquires the Most Advanced Computer Vision Technology for Tracking Human Motion

CEO Daniel Perez explained, “We won’t stop investing in technology to deliver the most patient-centered digital clinic that improves member experience and outcomes while reducing costs. wrnch allows us to take a giant leap forward in all respects.”

Dale W Wood Congratulates the Huma Team on Raising $130 Million

Major health and technology companies across the world have committed upwards of $130 million to Huma Therapeutics, the health-tech company backed by Dale Ventures.

Rhaeos Awarded $4 Million NIH SBIR Grant

Under the NIH SBIR grant, Rhaeos will leverage their existing wireless sensor hardware to provide additional quantitative flow data to the clinician, giving insight into this currently inaccessible and highly relevant shunt performance metric.

Gynesonics Announces FDA Clearance of Next Generation Sonata System

“This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of the treatment from within the sterile field,” said Jiayu Chen, Ph.D. Vice President, Engineering and Advanced Technologies at Gynesonics.

Blackrock Neurotech Invests In Groundbreaking Auditory Nerve Implant With University Of Minnesota And MED-EL

The new investment will enable the development and translation of a new ANI through preclinical studies and later, a pilot clinical trial, where the ANI is then implanted in up to three deaf patients.

Jonathan Chapman: New President/CEO of Trividia Health

Chapman said, “I’m honored to join the Trividia team as President and CEO. This organization has a long history of leadership within the healthcare industry as a provider of accurate, accessible, and affordable point-of-care solutions for the management of diabetes.”

SOLOPASS® System (Bedside Neuro-Navigation Device) Receives FDA 510(k) Clearance

inTRAvent’s SOLOPASS® system brings simple, portable, bedside neuro-navigation into the intensive care unit.

By using this website you agree to accept Medical Device News Magazine Privacy Policy