Overview

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Course Overview

  • Duration: 8 hours
  • Cost: $950 USD

The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) 2017/745 introduces significant changes to clinical evaluation requirements, making them more stringent, structured, and transparent.

Under the MDR, there are increased requirements for the Clinical Evaluation Plan (CEP), demonstration of equivalence, and post-market clinical follow-up (PMCF). Additionally, there is a stronger emphasis on the interaction between clinical evaluation and risk management. Manufacturers can no longer rely solely on equivalence and literature-based data — direct clinical investigations are required more frequently.

Also, the role of the Notified Bodies has also changed, requiring them to apply stricter scrutiny, especially for high-risk products.

Clinical evaluation should be viewed as a continuous process throughout a medical device’s entire lifecycle. Updates must be made not only in response to the device’s own post-market performance but also by considering the performance of equivalent devices.

This training course will guide participants through the complete clinical evaluation process, starting with establishing the scope and developing a solid CEP based on a clearly defined purpose. Participants will then be guided through key steps of the process, concluding with the appropriate content for the CEP and PMCF plan, along with their interactions with the Summary of Safety and Clinical Performance (SSCP) and the Periodic Safety Update Report (PSUR).

Additionally, special focus will be given to the relationship between clinical evaluation and risk management.

Learning Objectives
The training will equip participants with a stronger understanding of the clinical evaluation process in the following areas:

  • Develop a strong understanding of the clinical evaluation process and its interaction with risk management and post-market surveillance.
  • Gain insights into the regulatory requirements outlined in MDR Annex XIV, Articles 54, 55, 61, 32, and 86.
  • Understand the application of MEDDEV 2.7.1 Rev. 4 in clinical evaluation.
  • Learn how to apply guidance from MDCG Papers related to clinical investigation and evaluation, including 2020-5, 2020-13, 2020-8, 2020-7, 2020-6, 2019-9, and 2021-6.

Ideal Target Audience
While this course is available for everyone, we believe medical device manufacturers seeking certification for the European Market under Regulation (EU) 2017/745 would find the most value from this course.

Instructor Information
Our trainers have extensive expertise in certification processes and have worked with world-class manufacturers.

Rositsa Plaue is a Program Manager for MDR/IVDR at CSA Group with more than 10 years of experience in regulatory affairs and certification within a Notified Body. As a team lead for the certification of high-risk medical devices, she was responsible for overseeing clinical evaluations assessments and providing guidance on procedural requirements to align with regulatory requirements.

Benefits of Our Training

  • Clarity on Regulatory Requirements: A clear understanding of the regulatory requirements will help you determine whether to pursue the equivalence route or rely on your own clinical and/or performance data. By providing robust evidence of the equivalence for other devices, you can effectively prepare your clinical evaluation to meet the expectations of your Notified Body. This approach helps avoid unnecessary iterations and streamline the approval process for your products.
  • Expert Instructors: Our experienced trainers bring real-world knowledge and industry-leading insights to the classroom. They have a deep understanding of medical device certification according to MDR and IVDR.
  • Gain Confidence: Our training will equip your team with greater confidence in navigating applicable requirements and guidances, helping you demonstrate compliance with Annex XIV of the MDR.
  • Private or Public: We offer both public and private courses. For organizations with 10 or more participants, we can administer private training courses — allowing your team to ask questions and receive guidance tailored to your business. For organizations with less than 10 participants, we recommend our public courses. Our public courses have been designed by our industry experts to help your team understand a range of complex topics.
  • Hands-On Learning: Engage in practical exercises, case studies, and simulations to reinforce your understanding.
  • Certificate: Earn a Certificate of Completion upon successful completion of each course.

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