Clinical evaluation is a fundamental pillar of the European regulatory framework for medical devices. With the (EU MDR) 2017/745 coming into full force, the regulatory expectations for clinical evaluation for demonstrating clinical safety, performance, and benefit-risk balance have become significantly more rigorous than under the previous Medical Device Directive (MDD). In this regard, Clinical Evaluation plays a vital role in the lifecycle of a medical device, from its initial design to its post-market surveillance. Understanding and effectively implementing clinical evaluation processes is now essential not only for obtaining CE marking but also for maintaining it throughout the entire product lifecycle. It ensures that the device continues to meet safety and performance requirements throughout its commercial life.
Given the evolving regulatory environment, manufacturers must ensure that clinical data supports both the conformity assessment and the post-market monitoring of their devices.
Inadequate clinical evaluations can lead to non-compliance, delayed market access, and patient safety risks, potentially jeopardizing a device’s approval and reputation.
This training focuses on providing a comprehensive understanding of the requirements, processes, and best practices for conducting clinical evaluations in line with the EU MDR.
Participants to not only comply with the EU MDR but also gain expertise to navigate the complex landscape of regulatory compliance, strengthen clinical evidence for medical devices, and mitigate risks to patient safety through structured, evidence-based evaluation practices.
Core Topics Covered in the Training
- Clinical Evaluation Process in line with (EU MDR) 2017/745
- State-of-the-art (SOTA) determination
- Reviewing the upcoming ISO 18969
- Clinical Evaluation Regulatory Framework and Requirements
- Developing a Clinical Evaluation Plan (CEP)
- Conducting Literature Reviews and Clinical Investigations
- Clinical Evaluation Report (CER) and Documentation
- Ensuring Compliance and Risk Mitigation
- Case Studies and Practical Application
Target Audience
Professionals involved in regulatory affairs, clinical affairs, quality management, and compliance of medical devices.
Benefit
- Gain expert-level knowledge of the clinical evaluation process under the (EU MDR) 2017/745
- Be equipped to navigate complex regulatory requirements and ensure compliance in your clinical evaluation activities.
- Understand how to optimize clinical evidence to support device approval and ensure patient safety.
- Acquire practical insights to enhance your clinical evaluation processes, thereby avoiding regulatory pitfalls and delays.
Certificate
Participants receive a Certificate of Attendance of DQS MED GmbH
Interested participants from other time zones are welcome to contact us regarding the training at [email protected].
Auditors
