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CER (Clinical Evaluation Report) Training for EU MDR Compliance

The days of 10-page clinical evaluation reports are long gone. Today, Notified Bodies expect to see robust clinical data as a key component of your CE Marking technical documentation…even for low-risk devices. The May 2020 implementation of the EU Medical Device Regulation is sure to further elevate expectations.

Will you be ready?

This 3-day training class will walk you through all aspects of assembling a CER from the ground up as well as improving your existing clinical evaluation to meet new requirements. Using workshops and real-life examples, your instructor will address all facets of clinical data, clinical evidence, and clinical investigations, explaining the requirements for each and detailing all five stages of the clinical evaluation process. You’ll come away with a clear understanding of what is required to ensure that your CER withstands Notified Body scrutiny – and what you need to do to get there.

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.800.472.6477  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
Boston, MA 09/24/2019 3 $2995.00 Add to Cart CONTACT US
San Diego, CA 10/15/2019 3 $2995.00 Add to Cart CONTACT US
Orlando, FL 11/12/2019 3 $2995.00 Add to Cart CONTACT US
Minneapolis, MN 12/03/2019 3 $2995.00 Add to Cart CONTACT US
Edison, NJ 01/14/2020 3 $2995.00 Add to Cart CONTACT US
San Francisco Area, CA 02/04/2020 3 $2995.00 Add to Cart CONTACT US
Chicago, IL 03/03/2020 3 $2995.00 Add to Cart CONTACT US

What You Will Learn

  • Clinical evaluation report components related to EU MDR and MEDDEV 2.7/1 rev. 4
  • Relationship of CER to MDR 2017/745, MEDDEV 2.7/1 rev. 4, EN ISO 13485:2016, and EN ISO 14971:2012 
  • Relationship of clinical evidence to clinical data and clinical evaluation, with examples
  • Five stages of clinical evaluation under MEDDEV 2.7/1 rev. 4 and their role in the product life cycle
  • How clinical data is employed to support device purpose and use
  • Clinical investigation requirements under EU MDR, and rationale for when it is not needed
  • Creating a clinical evaluation plan in compliance with EU MDR and MEDDEV 2.7/1 rev. 4
  • Data collection processes and types, including the use of nonclinical data
  • “State of the art” with linkage to benefit-risk analysis
  • Data analysis using clinical literature as well as safety and performance data
  • Creating a PMCF plan for the CER and integrating postmarket surveillance and benefit-risk analysis

Who Should Attend

This class builds on our foundational EU MDR class and is appropriate for anyone working in regulatory, quality, risk management, or clinical roles with responsibility for creating, reviewing, or auditing CERs. Participants are expected to have some basic knowledge of clinical evaluation reports, risk management, and medical device regulation in Europe. 

Number of Days: 3
CEUs: 2.5
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Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.800.472.6477 or Contact Us.

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