Extra text: Interested participants from other time zones are welcome to contact us regarding the training at [email protected].
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Understand the key regulatory requirements and practical steps for achieving CE marking compliance under the EU MDR.
Why This Training Is Critical Now
The European medical device industry has undergone its most significant regulatory transformation in decades with the implementation of the Medical Device Regulation (EU) 2017/745 (MDR). Since its full application on May 26, 2021, manufacturers worldwide have faced unprecedented challenges in achieving and maintaining market access across the European Union’s 27 member states. The CE marking is no longer a mere regulatory checkbox, it represents a comprehensive framework for quality, safety and performance assurance that influences every stage of medical device development, manufacture and commercialization.
The CE Marking Essentials training offers a comprehensive and practical introduction to the regulatory landscape governing medical devices under the (EU) MDR. It is designed to equip participants with a clear understanding of the regulatory expectations, documentation requirements and procedural steps needed to obtain and maintain CE marking for devices placed on the EU market.
This course takes participants through the entire compliance journey from understanding the transition from MDD to (EU) MDR and its practical implications, to mastering the documentation requirements for CE marking and gaining insights into Notified Body expectations during conformity assessments and audits. Participants will also explore implementation challenges and learn effective strategies to overcome them, including best practices for managing audits and inspections, addressing non-conformities and embedding (EU) MDR compliance within an existing Quality Management System such as ISO 13485.
Through real-world examples, interactive discussions and case studies, this training bridges the gap between regulatory theory and operational application. It empowers professionals to navigate the complexities of the MDR with confidence, ensuring that medical devices meet all applicable EU requirements for safety, performance and market readiness while enhancing efficiency and reducing compliance risks.
Key Topics Covered
- Transition from MDD to MDR, highlighting key differences and practical implications
- Transitional Provisions under Article 120 and their impact on legacy devices
- Building Compliant and Robust Documentation for achieving and maintaining CE marking compliance
- Understanding Notified Body expectations during conformity assessments and audits
- Insights into implementation challenges and proven strategies to overcome them
- Application of knowledge through case studies, connecting regulatory concepts with real-world practice
Key Benefits:
This training provides a clear and practical understanding of the EU MDR requirements and their impact on medical device compliance. Participants will receive expert guidance on the transition from MDD to MDR, gain valuable insights into Notified Body expectations, and learn how to prepare thorough CE marking documentation. The course offers practical strategies to address common compliance challenges and demonstrates how to effectively integrate MDR requirements into existing quality management systems. Through real-world case studies, attendees will enhance their regulatory knowledge and improve organizational readiness, ultimately reducing compliance risks and facilitating smoother market access.
Target Audience: This course is suitable for Quality Assurance and Regulatory Affairs Managers, R&D and Design Engineers, anyone involved in the CE marking process for medical devices.
Auditors
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Irenej Polacek
Moderator
Technica file reviewer / Auditor
A graduate biomedical engineer specialising in prosthetics, orthotics, orthopaedics, and custom-made cranio-maxillo-facial implants, he worked at CEIT Biomedical Engineering during his PhD. He gained extensive experience in dental medical devices as a product specialist at FONA Dental, collaborating with the design team and end users. He then joined 3EC International, a Slovak notified body, where he spent four years as a technical file reviewer and lead auditor, completing training in MDR, risk management, usability, PMS, and external auditing. Later, at DQS, he earned certifications from their comprehensive MDR, ISO 13485, and MDSAP conformity assessment training.