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CER (Clinical Evaluation Report) Training for EU MDR Compliance

Can't travel? This class is also available virtually.

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 2021 implementation of the EU Medical Device Regulation further elevated expectations.

Are you ready?

This multi-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.

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Course Detail

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. 

  • Virtual Half-Days

    5
  • In-Person Full-Days

    3
  • CEUs

    2.5

Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Online Training Schedule

  • This training is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Standard Time.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

See course dates to find / register for a virtual online session of this course.

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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