Implants and EU MDR: Consistency in Implant Card, Summary of Safety and Clinical Performance and Periodic Safety Update Report

Learn more about the European Medical Devices Regulation (EU) 2017/745 (MDR) requirements that manufacturers need to provide about implants’ safety and performance, as well as a means of traceability for these devices.

Join us!

Thursday, June 23, 14:00-15:00 (Seoul, South Korea)

June 23, 2022

The European Medical Devices Regulation (EU) 2017/745 (MDR) requires the manufacturer to provide information about implants’ safety and performance, as well as a means of traceability for these devices. To this end, the manufacturer must create the following documents:

  • The device’s Summary Safety and Clinical Performance (SSCP) document must be available to the medical professional and the patient before they decide to implant the device. 
  • The Periodic Safety Update Report (PSUR) must provide information regarding the device’s safety. The Notified Body will review the PSUR and upload it into Eudamed along with their review report. 
  • Finally, each patient must receive an implant card that identifies the device up to the level of individual batches or serial numbers. 

This webinar will explain these new concepts and how they interact. It will also explore market surveillance authorities’ perspective and bring the use of Eudamed into a wider context. Implant manufacturers will benefit from this webinar, as will other manufacturers of high-risk devices. 

(*This webinar was recorded on June 24, 2021.)
 

PRESENTERS

  • Ronald Boumans

    Ronald Boumans, a senior consultant for Regulatory Affairs with specific Brexit expertise, will present the webinar. Ronald acts for Emergo in the European Association of Authorized Representatives (EAAR) and represents EAAR at the European Commission in Brussels. He has also worked with the foundation of the U.K. Responsible Person Association (UKRPA), an organization that represents Responsible Persons for the U.K., and has frequent meetings with the MHRA (Medicines and Healthcare Products Regulatory Agency).