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EU MDR CER (Clinical Evaluation Report) Training for Medical Devices

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 European CE Marking technical documentation, even for low-risk devices. This 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 EU MDR requirements. 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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Brief Overview of This Training Class on Medical Device Clinical Evaluation Reports

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Days

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person

Certification of Completion

Yes

Continuing Education Units (CEUs)

2.5

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming EU MDR Clinical Evaluation Report (CER) Classes

SkillsLab $3895

SkillsLab $3895

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
ECF VIRTUAL DELIVERY (Eastern time - PM) 08 Jul 2024 12 Jul 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
ECF VIRTUAL DELIVERY (Eastern time - PM) 04 Nov 2024 08 Nov 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER

GROUP DISCOUNT

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25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive EU MDR CER Training Class

This course walks you through all aspects of assembling a CER from the ground up, as well as improving your existing clinical evaluation to meet new requirements. The content addresses 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.

Course Overview
SkillsLab Class

Introduction to Clinical Evaluation in the EU (EU MDR, MEDDEV)

  • Clinical evaluation process and the EU MDR; linkages to other processes
  • Role of MEDDEV 2.7/1 rev. 4 guidance document
  • Regulatory oversight of clinical evaluation

Clinical Data and Claims

  • Role of clinical data in clinical evaluation, including definitions, types, and sources
  • Linking claims to intended purpose and clinical performance
  • Best practices for managing claims
  • Clinical benefits and relationship to claims
Workshop! Clinical Data – Identifying Product Information

Clinical Evaluation

  • Clinical evaluation as a life-cycle process, relationship with clinical data identification and gathering
  • MEDDEV 2.7/1 rev. 4 guidance for clinical evaluation
  • Five stages of clinical evaluation process
  • EU MDR requirements for clinical evaluation
  • EU MDR QMS requirements related to clinical evaluation
  • Well-established technologies (WET)
Workshop! Clinical Evaluation Process – Well-Established Technology

Clinical Evidence

  • Clinical evidence in relation to clinical evaluation
  • Requirements for clinical evidence
  • How to determine sufficiency of clinical evidence supporting safety and performance
  • The PICO model for clinical evidence support

Clinical Investigations

  • Purpose of clinical investigations and when needed under the EU MDR
  • The process for initiating and conducting clinical investigations
  • Use of EU expert panels for consultation
  • EU MDR reporting requirements for adverse events occurring during clinical investigations

Components of a Clinical Evaluation Report

  • EU MDR requirements for clinical evaluation reports (CERs)
  • MEDDEV 2.7/1 rev. 4 guidance for developing CERs
  • CER content sections
  • Relationship of CER to technical documentation
  • Best practices in CER and medical writing
  • Notified Body clinical evaluation assessment reports (CEARs)

Clinical Evaluation Planning

  • EU MDR clinical evaluation plan (CEP) requirements
  • Stage 0 of the clinical evaluation process (scoping)
  • Best practices in CEP construction
  • CEP review and updates
Workshop! Clinical Evaluation Plan Development

Data Identification and Collection

  • The data collection process for clinical evaluation (Stage 1: Identify pertinent data)
  • Identify types of data: clinical, nonclinical, and postmarket
  • Best practices for data collection and management in clinical evaluation
Workshop! Data Collection and Identification

Clinical Literature Search and State of the Art

  • The clinical literature search process
  • Clinical literature search plan and strategy
  • Role of state of the art
  • Summarizing the clinical literature search and state-of-the-art search results
Workshop! Clinical Literature Search Strategy

Data Appraisal and Data Analysis

  • The data appraisal process (Stage 2) of clinical evaluation
  • How to plan and conduct the data appraisal
  • How to determine relevance of clinical data sets
  • The data analysis process (Stage 3) for clinical evaluation
  • Data analysis considerations
  • How to conduct the summary analysis of clinical data sets
Workshop! Data Appraisal and Analysis of Clinical Literature

Equivalent Devices

  • Device equivalence in the EU MDR
  • How to establish device equivalence using guidance from MEDDEV 2.7/1 rev. 4
  • How to address device equivalence in the CER

Benefit-Risk Analysis

  • Relationship of EN ISO 14971 risk management to clinical evaluation
  • Purpose of the benefit-risk analysis
  • EU MDR benefit-risk analysis requirements
  • The benefit-risk analysis in the CER
Workshop! Clinical Benefits vs. Risk of Device

Postmarket Surveillance

  • CER and postmarket surveillance as part of Stage 4: The clinical evaluation report
  • EU MDR postmarket surveillance planning and reporting requirements
  • Linking postmarket planning and reporting to clinical evaluation
  • Summary of safety and clinical performance (SSCP) document
  • Postmarket data and the CER

Postmarket Clinical Follow-Up

  • Relationship of postmarket surveillance to postmarket clinical follow-up (PMCF)
  • PMCF requirements in the EU MDR
  • MEDDEV PMCF guidance
  • How to create a PMCF plan
  • How to compile and develop a PMCF evaluation report
  • PMCF inputs to clinical evaluation process
Workshop! PMCF Planning Process

Summary and Conclusion of the Clinical Evaluation Process

  • Review CER requirements, the CER’s summary section, and the CER’s conclusion section
  • Life-cycle management of the clinical evaluation process
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Describe EU MDR requirements related to clinical evaluation reporting and postmarket clinical follow-up (PMCF).

Define clinical data and how it is used to support a device’s intended purpose and indications for use. 

Define clinical evidence, its relationship with clinical data and clinical evaluation, and clinical evidence examples.

Explain the five stages of the clinical evaluation process (MEDDEV 2.7/1 rev. 4) and the process’ role in the device life cycle. 

Describe how to develop a clinical evaluation plan in compliance with EU MDR and MEDDEV 2.7/1 rev. 4. 

Describe data collection processes and types, including the use of nonclinical data.

Explain data appraisal, handling clinical literature, equivalent devices, state of the art, and benefit-risk analysis.

Discuss data analysis using clinical data sources in relation to safety, performance, and benefit-risk analysis.

Identify clinical evaluation report components related to the EU MDR and MEDDEV 2.7/1 rev. 4.

Define clinical investigation, its requirements under the EU MDR, and rationale for when it is not needed. 

Define postmarket clinical follow-up (PMCF), rationale for when it is not needed, and how to develop a PMCF plan.

Who Should Attend

Who Should Attend

Recommended 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.

  • RA/QA Specialists
  • Consultants
  • Risk Management Specialists
  • Clinical Professionals
  • CER Auditors
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