Understanding the regulatory requirements for successful post-market surveillance of medical devices and IVDs is increasingly important and practical application of the regulations is key to a successful PMS system.
This course will provide a clear understanding of the intention of the requirements, and discuss the responsibilities of the manufacturer, notified bodies and competent authorities. It will also provide advice on where to find useful guidance and will include an insight into some possible PMS methodologies for a range of example medical devices and IVD products, including software.
A review of the reporting and documentation obligations will be included, to enable participants to fully understand and comply with the documentation requirements.
The regulations for PMS under the MDR and IVDR are complex and this course provides an excellent opportunity to gain essential knowledge, practical application and interpretation of the requirements.
Benefits of attending
- Understand the intention of the regulatory requirements for PMS
- Gain knowledge of the available sources of guidance on the subject of PMS
- Practice the setting of objectives and criteria for collection of PMS data
- Explore some possible PMS methodologies for a range of example products covering Medical Devices and IVDs including software
- Learn the reporting and documentation obligations
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Course Content
Background of regulatory requirements for PMS
- EU requirements - MDR 2017/745 and IVDR 2017/746 - Articles 83-100
- UK Medical Device Regulations 2002 No. 618 as amended
- Responsibilities of the manufacturer/notified bodies/competent authorities with respect to PMS
Overview of guidance sources available on PMS
Practical application of PMS
- Objectives of PMS
- Relationship of risk management to PMS
- Commercial benefits of good PMS
Possible methodologies
- Discussion of potential sources of PMS and methods available depending on device type
- Trend reporting/signal management
Case studies - Interactive session and workshop
- Walk through of case studies representing different risk classifications of medical devices, including software and in-vitro diagnostics
PMS system documentation
- PMS Plan/Report
- Periodic Safety Update Report (PSUR)
Q&A discussion
