Course Description

Clinical Evaluation for Market Approval

Course Description:

Manufacturers planning to market their devices in Europe are required to provide clinical data in line with the European Medical Device Regulation

This intensely comprehensive course on Clinical Evaluation for Market Approval will empower you with the essential information, requirements and guidelines you need to successfully and accurately conduct clinical evaluation either as part of the compliance with the EU MDR or as part of the planning of prospective clinical investigations anywhere in the world. From regulatory process and compliance to literature review and conformity; get on the right track to market approval today.

Part 1: EU-MDR Clinical Evaluation Process 
The first installment provides professionals with an expert overview of the EU regulations and how they can positively impact global market access as well as a detailed outline of the necessary steps to follow to achieve immediate and lasting compliance of their clinical evaluation process.

Part 2: Clinical Evaluation Plan and Literature Review Process
Formulate a plan as a basis of the clinical evaluation process. Learn how to establish safety and performance claims, and accurate considerations of standard of care as well as derive meaningful information from the risk assessment, form an important basis for the clinical evaluation plan. Effectively prepare and conduct a literature review according to the MEDDEV 2.7.1 guidelines and EU MDR requirements; You will learn how to generate valid clinical evidence to enhance device acceptance in routine medical practice as well as within the EU regulatory framework.

Part 3: Clinical Evaluation Analysis and Report
In the final course you will learn the steps for producing the clinical evaluation report - including substantiating device claims, standard of care as well as clinical data analysis, critical discussion and conclusion to determine conformity for CE marking, plan post market surveillance activities or designing clinical investigations.

Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:

  • Distinguish the different methods to obtain clinical data for EU market access and understand how the conduct of a critical review of existing data lays the basis for a decision to embark upon a prospective clinical investigation or not.
  • Comprehend and interpret the requirements of MEDDEV 2.7.1. guideline and EU MDR requirements regarding the methodology for a critical review of existing data.
    • Setup a methodology to define appropriate existing data
    • Define device performance and safety claims
    • Select predicate devices to substantiate claims
    • Position the new medical device compared to existing standard of care
    • Conduct the literature search & review (literature search protocol)
    • Illustrate clinical data identification and appraisal
    • Interpret critical assessments, selection and appraisal in determining conformity with the Medical Device Regulations
    • Produce the report including valid conclusions

Who Should Enroll:

Senior clinical and regulatory managers, clinical research directors and vice presidents, medical writers, regulatory affairs directors, and regulatory affairs vice presidents involved in the strategic planning of clinical evaluations for the EU and medical device global market access are all encouraged to participate in this course.

Prerequisite Knowledge/Requirements:

Understand the requirements of  the Medical Device Regulations as outlined in course IDN 180 and  ISO 14155 as outlined in either ISO 14155 an in-depth review (IDN 158, IDN 176, IDN 177, IDN 178, IDN 184, IDN 185) or ISO 14155 - A Summary Review (ID 144).

Subject Matter Expert:
Danielle Giroud

80 min

Related resources:

Case studies:

Basic Account: € 352.00
Premium Account: € 264.00

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