Clinical Evaluation Reports Under the New EU MDR

by | Dec 18, 2019 | EU MDR, Medical Devices

The new EU Medical Device Regulation (MDR) was published in the Official Journal of the European Union on May 5, 2017, marking the beginning of the transition period for any medical device manufacturer selling devices in Europe.1 This new regulation replaces the Medical Devices Directive and the Active Implantable Medical Devices Directive and includes changes to several critical requirements. Medical device manufacturers will notice that there are updated
requirements for technical files, and specifically for clinical evaluation reports. In this paper, we will cover what a clinical evaluation report is and how the requirements under the new regulation differ from the previous directive.

Get the Clinical Evaluation Reports Under the New EU MDR Whitepaper

Fill out the form below, and the webinar will get sent directly to your inbox.
Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

More Resources

FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.

Ready to learn more about working with us?

Pin It on Pinterest

Share This