Purpose and outcome

The purpose of this course is to provide you high level details on regulatory requirements on post market surveillance (PMS) and vigilance on medical devices and how to ensure regulatory compliance when marketing medical devices in EU and US.

After the course, your will have essential knowledge and skills within PMS and on how to conduct a PMS plan, report and PSUR.

Content of training

In today’s regulatory context, post market surveillance is a necessary part of the medical device and combination products life-cycle, requiring analysis of information from both reactive and proactive sources, and its integration, under the quality system, with the device risk management and clinical evaluation programs, in order to maintain regulatory compliance. Increased enforcement of device regulation is an inevitable consequence of publicity in recent years concerning higher risk devices, but manufacturers should be aware that PMS requirements apply to all classes of device under both (Medical Device Directive, MDD) and (Medical Device Regulation, MDR) European legislation. Regulatory authorities expect manufacturers to have a PMS plan for each device family, and for the feedback obtained to be used effectively in managing device-associated risks. The ideal PMS program should not only gather data relative to current production but also identify consumer needs for continued product development.

The course will focus on European requirements, in particular the significantly increased PMS requirements under the MDR but will also touch on US FDA expectations. This course will provide the knowledge to allow delegates to develop their own PMS strategies to meet MDR requirements and will include ample time for delegate interaction and discussion.

The ISO/TR 20416 ”Medical Devices - Post Market Surveillance for manufacturers”  is under revision and will partly (as it is not yet published) be used in the presentation as guidance. MDCG guidance will also be included.

Who should attend?

Post market surveillance touches many functions within the medical device industry. The following functions will benefit from the course:

• Regulatory
• Safety & risk management
• Quality Assurance
• Clinical Affairs
• Marketing

Trainer

Anette Sjögren, PREVENTIA AB

Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.