Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

Why Should You Attend:

You should attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system according ISO 13485:2021 like post-market-surveillance plan and report and how to create the annual PSUR – Performance Safety Update Report to the Notified Bodies and EUDAMED in a simple and quick way. Your implementation need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.

The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the “Post-Market- Surveillance-Process” and the new requirements e.g. reporting to Competent Authorities and Notified Bodies and how this process is connected to other processes in the quality management system according EN ISO 13485:2021. The understanding of this changes and how to implement changes is essential to keep your certificates and to keep the market entry open.

Learning Objectives:

• Introduction, who must apply the new EU MDR 745/2017 requirements
• Overview about the changes of the EU MDR 745/2017 regarding “Post Market Surveillance” of your products
• Explaining of each change
• Smart and fast ways to implement the changes in your quality management system
• Fast track internal audit to approve the changes

Areas Covered in the Webinar:

• How to define a “Post-Market-Surveillance-Process”?
• How to create the new required reports for the Notified Body and the Competent Authorities?
• How to do adjustments in the management review
• How is the Post-Market-Surveillance-Process” connected to clinical evaluation, customer feedback, complaints and vigilance?

Frequently Asked Questions:

1. We are manufacturer of implantable diaphragm pacemaker and we only sell low volume. Can we use number of patients when doing PMS rather than number of devices sold?
2. For example we sold 30 for the year. we received a 2 complaints. Do we calculate the 2 complaints based on the devices sold or can we use number of active patients? complaint linked to use of the device?
3. For Post-market clinical follow-up if I understood correctly it is NB that will send to EUDAMED but not clear for ICSR reports for 15 day reports. For vigilance reporting for 15 day - will manufacturer be required to report directly to EUDAMED?
4. What about if the complaint was due to user error? Do you need to include this to the PMS as a complaint?
5. Package damage can be from delivery person/agency also, so are we responsible to note?
6. Do you need to do PMCF if you a have good PMS report?

Who Will Benefit:

CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of

• medical device manufacturers
• importer
• distributors
• dealers

who work with European Union, European Economic Area, Switzerland and Turkey

Frank Stein
Senior Expert Medical Devices, Frank Stein healthcare projects

Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience for 27 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Brazil.

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