MT8 - Clinical Evaluation & Post-Market Surveillance under MDR

Learn how to establish and maintain clinical evidence throughout the medical device lifecycle under the MDR.

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Course Information

1 day
17 November

Investment

The investment is €795,- per participant (ex. VAT).

Included are the course material, beverages and lunch

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Clinical Evaluation & Post-Market Surveillance under MDR

This course provides participants with a practical understanding of the requirements for Clinical Evaluation, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) under the Medical Device Regulation (MDR 2017/745). The training also briefly addresses the role of clinical investigations in generating clinical evidence where required.

The course is designed for medical device professionals involved in clinical affairs, regulatory affairs, quality assurance, and compliance activities. It is particularly relevant for individuals responsible for clinical evaluation, PMS, PMCF, or related documentation.

Participants will gain insight into how Clinical Evaluation, PMS, PMCF and Risk Management work together to support the ongoing safety, performance and regulatory compliance of medical devices.

This training is also well suited for organizations seeking to establish or enhance their post-market processes and effectively leverage post-market data to support continuous improvement and maintain compliance. Prior knowledge of the MDR is beneficial, but not required.

What will you learn

Our training provides a comprehensive understanding of Clinical Evaluation, Post-Market Surveillance (PMS), and Post-Market Clinical Follow-up (PMCF) under the European Medical Device Regulation (MDR 2017/745).

Participants will gain practical insight into how intended purpose and device claims influence clinical evidence requirements, how clinical evidence is generated and maintained throughout the medical device lifecycle, and how Clinical Evaluation, PMS, PMCF, and Risk Management work together to support the ongoing safety, performance, and regulatory compliance of medical devices.

The training also provides practical guidance on the planning, execution, and documentation of Clinical Evaluation, PMS, and PMCF activities, including the role of clinical investigations where required.

Program:

The impact of intended purpose and device claims on Clinical Evaluation
Clinical evidence requirements throughout the medical device lifecycle under the MDR
Conducting systematic literature searches and literature reviews to identify and evaluate available clinical data
Clinical Evaluation planning, conduct and documentation
Clinical investigation requirements and when a clinical investigation may be required
The relationship between Clinical Evaluation, Risk Management, PMS and PMCF
PMS requirements and the collection and evaluation of post-market data
PMCF objectives, methods and documentation requirements
Key elements of Clinical Evaluation Reports (CERs) and PMS reports / Periodic Safety Update Reports (PSURs)\
The key elements of the Clinical Evaluation Report

Learnings:

How to apply a risk-based approach to Clinical Evaluation, PMS, and PMCF activities
How to identify and assess appropriate sources of clinical evidence throughout the medical device lifecycle
How PMS/PMCF data can be used to support the ongoing assessment of device safety and performance
How to translate post-market insights into improvements to devices, processes and documentation

Instructors

Lena Böttinger

Sr. Project Manager Medtech

Lena Boettinger is a MedTech expert and biomedical scientist specializing in clinical evaluation and validation of medical devices. With a PhD in biomedical sciences, she has extensive experience generating and assessing clinical evidence under MDR and IVDR, supporting companies in demonstrating safety, performance, and clinical benefit. As a QA/RA consultant at Holland Innovative, she helps organizations build robust, compliant clinical evidence across the product lifecycle.

Register now by filling in the following form.

After your registration, we will schedule an intake by telephone with you . During this conversation we will discuss the training content, how this training will help you with your challenges and any further questions.

Clinical Evaluation & Post-Market Surveillance under MDR

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Practical information.

For whom

This training is designed for medical device professionals who wish to increase their knowledge and understanding of clinical evaluation and post-market surveillance (PMS). It is highly recommended for individuals who are responsible for conducting clinical evaluation and/or post-market surveillance within their organization.

Additionally, this training is well-suited for companies who want to improve their PMS and are looking for guidance on how to effectively manage the data collected post market. While prior experience with the Medical Device Regulation (MDR) is beneficial, it is not essential for attending this training program.