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 Green

Madison Green

Director of Technical Operations - Mrs. Green 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. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green 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

Establishing a Culture of Compliance

Establishing a Culture of Compliance

While having robust compliance policies and procedures in place is essential for meeting regulatory requirements, it's equally important to establish a culture of compliance within your organization.  A culture of compliance means that every employee understands the importance of compliance and is committed to upholding it in all their work. Here are some tips for establishing a culture of compliance...
Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...

Ready to learn more about working with us?

Pin It on Pinterest

Share This