REC Webcast - EU MDR: Experience gained from post-market surveillance and reporting

1.0
RAC Credits
Virtual Programs Virtual Programs Europe Europe
Wednesday, 08 September 2021 (4:00 PM) - Wednesday, 08 September 2021 (5:15 PM) Central European Time (CET)

Your participation in the regulatory community is vital. The RAPS European Council (REC) is offering this webcast so that global regulatory professionals maintain access to valuable knowledge about issues currently impacting our industry.


Description

The date of full application (DofA) of the medical device regulation being now behind us and the regulation fully in use. The provision of post market surveillance applies to all devices, even those who are not yet MDR CE marked and now in the grace period defined in art. 120.

This REC webcast will give early experience gained from the use of the new PMS processes, and will discuss how the COVID-19 pandemic has affected PMS activities and may lead to possible changes in the future.


This event is brought to you by the RAPS European Council (REC) to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.


Learning Level: Intermediate

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.


Pricing Amounts and Deadlines

Wednesday, 8 September 16.00 – 17.15 CET
Member: €10
Nonmember: €25


Agenda

• Welcome attendees, housekeeping notes (5 min) – Piero

• Introduction of the topic and speakers (5 min) – Philippe

• Manufacturer’s experience meeting PMS requirements under EU MDR (25 min) – Markus

• Presentation 2 (please provide the title) (25 min) – Philippe

• Q&A & closing remarks (15 min) – Philippe and Markus


Speakers


Philippe Auclair, Senior Director, Regulatory Strategy and Advocacy, Abbott Quality and Regulatory

Philippe joined Abbott in 1994. He represents European Industry in various European Commission expert groups and actively participates as trainer in programs organized by Regulatory Authorities around the world. Since 2015 he is an Industry advisor to the Asian Harmonization Working Party Technical Committee. He is Chairman or co-chair of the Post Market Surveillance, the Notified Body, the International Regulatory and the clinical Working Groups of the European medical device manufacturers’ trade association Medtech Europe. He is a member of the European Advisory Committee and of the board nominating committee of the Regulatory Affairs Professional Society (RAPS). Philippe received the “Global Leadership Award” from RAPS in 2010, has been elected “RAPS Fellow” in 2012. Philippe is also the proud recipient of an FDA CDRH Director’s “Special Citation” for his work at Global Harmonization Task Force.


Markus Poettker, PMS EU MDR Workstream Lead, Smith&Nephew

Markus is a member of the EU MDR Project team at Smith&Nephew leading the Post Market Surveillance work stream. In this role, he is responsible that the requirements of the EU MDR are correctly interpreted and implemented across the company. Prior to this, he spent seven years in Quality & Regulatory roles, at last he was the Director of Complaint Management and Head of Regulatory Compliance with global responsibility for Complaint Handling, Medical Device Reporting and interaction with Regulatory Agencies. Markus is co-chair of MedTech Europe PMS & Vigilance Working Group and a member of the corresponding standard committee to ISO TC 210 at the Swiss Association for Standardization. Markus holds a master’s degree in law from WWU Münster, Germany.

Looking for More Euro-Centric Regulatory Content and Professional Development?

Take a deeper dive into some of the most pressing issues impacting our community today—including IVDR, Post-Market Surveillance in Europe, Design Controls and Data Management. Explore our up-coming European workshops produced in collaboration with the RAPS European Council (REC). Learn more and register.


Join our RAPS Community

RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Learn more about RAPS membership.


How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A Q&A portion with the speakers will follow the presentations, were selected questions posed through the chat will be discussed and answered.

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