This online course provides an introduction to regulation of medical devices within the European Union, its aim is to provide the student with a sufficient knowledge base to facilitate further study or training in the area of EU medical device regulation. The course introduces the student to the existing governing regulatory framework along with its associated concepts and definitions. It discusses the importance of regulation in balancing the competing requirements of early access to innovative medical device technologies and upholding the highest standards of safety and quality. The roles and responsibilities of the key stakeholders in the medical device regulatory process including Manufacturers, Competent Authorities and Notified Bodies are discussed and the essential components of the conformity assessment and CE marking process are elucidated. Accordingly, device classification, conformity assessment routes, clinical data, clinical evaluation and investigations as well as the importance of post-market surveillance and vigilance are covered in greater detail. In addition, selected case study examples are given of how the Manufacturer navigates the medical device regulatory process from the early stages of development to market. The final part discusses the rationale for, and impact of, recent revisions to the EU Medical Device regulatory framework.
Course Coordinator: Dr Anne-Marie Miller, CRDI
Course content will be accessible online and participation is self-paced within defined timeframes. The course is supported by a 2 hour workshop which will be delivered at the end of the online period. The course content will be examined thereafter by online MCQ.
CRDI certificate and CRDI open badge will be awarded to all successful course participants
Registration for expressions of interest is closed
*Full participation in all course components is required for award of CRDI certificate and/or open badge as appropriate
** Course workshop will be delivered in CÚRAM, Biomedical Science Building, NUIG unless otherwise stated
***Next course delivery: tbc
- Session 1: Medical Device and Regulatory Fundamentals
Key stakeholders, Legal instruments, Definitions
- Session 2: Medical Device Technical, Health and Safety specifications
Medical Device Directives/Regulations and CE Marking
- Session 3: Risk Classification, Conformity Assessment and CE Marking
Essential requirements and Harmonised Standards
- Session 4: Clinical Evaluation and Clinical Investigation
Clinical Evaluation and Clinical Investigation processes
- Session 5: Post-Market Activities
Post-Market Surveillance and Post-Market Vigilance
- Session 6: Basis for EU Medical Device Regulatory Framework Reform
Drivers of change and key outcomes
Indicative Learning Outcomes
On successful completion course participants should:
1. Understand the legislative framework for medical device regulation in the EU.
2. Determine if a device or product qualifies as a “medical device”, “active implantable medical device”, “in vitro diagnostic medical device” or “drug-device” combination under the definitions contained within the Directives.
3. Describe the importance and process of medical device classification and outline the criteria used in the classification process.
4. Explain the purpose and process of CE marking.
5. Outline the role of competent authorities and notified bodies in the CE marking and regulation of medical devices in Europe.
6. Define and explain the importance of essential requirements.
7. Explain the process of conformity assessment and the use of harmonised standards.
8. Define and explain the role of clinical data, clinical evaluation and clinical investigations.
9. Outline post market surveillance and vigilance reporting requirements.
10. Outline the basis for revising the EU Medical Device Regulatory Framework and explain the key changes which will be introduced.
Registration for expressions of interest is closed. Next course delivery tbc