Training Features

Clinical Evaluation for Medical Devices under the EU MDR​

Join our practical training on 16 and 23 July 2026 2026 to streamline clinical documentation and ensure EU MDR compliance for medical devices.
Format

Virtual Training

Level

Basic

Date

8 and 15 October 2026

Time

15:00 - 17:00 CET

Duration

2 x 2 hours

Trainer

Jasmin Hunter

Certificate

Certificate included

Price

€ 895 or equivalent currency

Clinical Evaluation for Medical Devices under the EU MDR

Clinical evaluation is a critical requirement under the Medical Device Regulation (MDR) 2017/745, ensuring that medical devices meet safety and performance standards based on clinical data. Manufacturers must continuously assess clinical evidence throughout the device lifecycle, integrating it into their regulatory documentation, including the Clinical Evaluation Report (CER). 

Led by Jasmin Hunter, this training helps medical device manufacturers understand and implement the clinical evaluation process in compliance with MDR. This training provides practical insights into gathering clinical data, conducting literature reviews, meeting Notified Body expectations, and maintaining ongoing compliance.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
The EU Medical Device Regulation (MDR) requires strong clinical evidence to demonstrate the safety and clinical performance of medical devices. Clinical data obtained through clinical evaluations and, when necessary, clinical investigations is essential for obtaining CE marking and for maintaining compliance once the device is on the market. The MDR, along with its supporting guidance documents and applicable standards, is detailed and requires careful interpretation based on the specific type of device.

This interactive training offers a clear and structured overview of the clinical evidence requirements under the MDR. You will explore the most recent regulatory expectations and guidance to help ensure the collection of appropriate and sufficient clinical data. The course covers the full clinical evaluation process, including clinical investigations and post market clinical follow up activities. You will also learn about the required clinical documents, including the Clinical Evaluation Plan, Clinical Evaluation Report, Clinical Investigation Plan, Clinical Investigation Report, Clinical Development Plan, Summary of Safety and Clinical Performance, and Post Market Clinical Follow Up Plan.

This training is designed for professionals working in clinical, regulatory, or quality roles and provides the knowledge and tools needed to carry out compliant and effective clinical evaluations.
Key Learning Objectives
  • Understand the regulatory requirements for clinical evaluation under MDR. 
  • Learn how to develop a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER). 
  • Gain insights into literature reviews, clinical investigations, and data appraisal. 
  • Understand how to generate and justify clinical evidence for medical devices. 
  • Learn how to integrate clinical evaluation with PMS and PMCF activities. 
  • Identify common pitfalls in clinical evaluation and how to avoid them. 
  • Ensure compliance with Notified Body expectations for clinical evidence. 
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training sessions
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered over two sessions, each lasting 2 hours, providing a focused and efficient learning experience. The sessions will take place on 8 and 15 October 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If the December training dates are not suitable, additional sessions will be held on 11 and 18 February, 9 and 16 April, and 16 and 23 July 2026. More information can be found on the registration pages.
Who Should Attend?
  • Regulatory Affairs professionals responsible for clinical evaluation compliance 
  • Clinical Affairs and Clinical Research professionals conducting evaluations 
  • Quality Assurance (QA) professionals involved in CER preparation 
  • Medical device manufacturers seeking MDR compliance for clinical evidence 
  • Post-Market Surveillance (PMS) and PMCF specialists 
  • Anyone involved in generating and maintaining clinical evaluation documentation 
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Regulatory Framework for Clinical Evaluation: MDR requirements for clinical evaluation (Article 61 & Annex XIV), the relationship between clinical evaluation, risk management, and PMS, and key guidance documents (MDCG 2020-5, MDCG 2020-6, MDCG 2020-13). 
  • Clinical Evaluation Process & Documentation: Stages of clinical evaluation (planning, data collection, analysis, and reporting), writing a compliant Clinical Evaluation Plan (CEP), and preparing the Clinical Evaluation Report (CER).
  • Sources of Clinical Data & Data Appraisal: Literature review versus clinical investigations, evaluating equivalent devices under MDR (MDCG 2020-5), and assessing clinical data quality and relevance for conformity assessment.
  • Clinical Evidence & Justification for Devices: Requirements for different device classifications, demonstrating sufficient clinical evidence for legacy devices, and PMCF as a key component of continuous clinical evaluation. 
  • Integration with Post-Market Surveillance (PMS) & PMCF: Using PMS and PMCF data to update clinical evaluation, aligning CER updates with Periodic Safety Update Reports (PSUR), and best practices for maintaining clinical evaluation throughout the device lifecycle. 
  • Notified Body Expectations & Common Pitfalls: Lessons learned from Notified Body reviews of CERs, Common deficiencies and how to address them, and strategies to ensure a smooth conformity assessment process.

Flexible Online Clinical Evaluation Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience, and gain clear, actionable insights into the clinical evaluation process and its critical role in demonstrating compliance with the EU MDR.

Expert-Led Clinical Evaluation Training for Practical Compliance

Meet the Trainer

Jasmin Hunter

Jasmin Hunter, Senior Consultant in Clinical & Regulatory Affairs, brings 7 years of experience in clinical evaluations and quality systems for Class IIa devices, combining regulatory expertise with product management and a strong medical writing background.