Medical Devices (includes In Vitro Diagnostics)
Guess what? It’s September 2019! Some notified bodies have been certified to MDR, notified body submission and audits have occurred, and minimal MDD renewal submissions are allowed. How is it rolling out? Do the notified bodies have increased scrutiny? Are medical device manufacturers getting findings for legacy issues not previously identified? Is a lack of clinical evidence causing products to be pulled from the market? Have notified bodies stopped accepting MDD renewals? How are manufacturers responding to all of this and continuing to be successful during this change?
Learn tips and lessons from industry experts who have been in the thick of this since 2017.
Hear directly from those with hands-on EU MDR experience and feedback from notified bodies! The panel will be comprised of notified body representation and companies who started EU MDR implementation planning in Q4 2017 and implementations January 2018; including early pilot submissions to notified bodies. 2018 and 2019 have been packed with large full-scale implementations of all aspects of the EU MDR including preparation of technical documentation submissions pending notified body certifications. These implementations are filled with challenges and interpretation questions.
You will hear stories, best practices, successes, and failures from a cross-functional panel – including a notified body. Aspects include:
• Implementation elements like portfolio reduction
• Optimizing your schedule
• Regulatory file transitions
• QMS changes
• Labeling changes
• Remediation of longstanding issues that will no longer pass
• Training and change management
• …and much more
Hear many examples of findings from the MDR 2018 pilot and 2019 early submissions, as well notified body audit findings related to MDD compliance issues not previously cited.
Prepare to return to your company inspired by real-world examples and ready to act!