Medical Device Regulations & Compliance Summit 2022

CONFERENCE OVERVIEW

The initial three-year transition period for the EU Medical Device Regulation 2017/715 (MDR) was expected to end in May 2020. Once the COVID outbreak occurred, the European Commission proposed to extend the implementation date by one year. The IVDs parallel regulations will apply from May 2022. However, it is important to note that this delay should not be considered as a grace period. Ultimately, the regulations have been updated to ensure that the health and safety of patients is a top priority.

Our virtual meeting proposes the actions medical device manufacturers could take to strengthen the implementation strategy for EU MDR and IVDR. The expert speakers will share all the different ways to prepare your company and team for a smooth transition; update your QMS for EU MDR; meet Notified Body expectations during the audit; comply with requirements for vigilance reporting and post-market surveillance; review labeling and packaging challenges under updated UDI; evaluate strategies to remediate gaps in clinical data and more.

Learn valuable insights and get answers on how to improve the efficiency of the implementation process in terms of time, cost and stuff. We look forward to e-meeting you at the event!

WE WILL TALK ABOUT

• EU MDR implementation lessons learned: notified bodies perspective.
• Challenges to implement the MDR.
• How to approach risk management under MDR.
• Performing post market clinical follow-up (PMCF) activities.
• Clinical evaluation for a medical device under MDR.
• How to meet post market surveillance requirements.
• Risk management in support of EU MDR compliance.
• Fundamental challenges to IVDR technical documentation.
• Eudamed, the latest and experiences so far.
• Extractables & leachables studies as important part of biocompatibility assessments.
• Journey and lessons learnt by the first company to achieve a certification of their QMS system and product against the EU MDR.
• Biocompatibility of medical device/medical device combination products.
• Biological safety evaluation over product life cycle.

WHO IS IT FOR?

CxO, VP, Directors, Heads, Managers of

• MDR/ IVDR
• Medical Devices/In Vitro Diagnostics/ Combination Products
• Regulatory Affairs/ CMC/ Compliance
• Device Development/ Device Engineering
• Design Controls/Device Design
• Risk Management/ Safety Risk
• Traceability/ Sterilization
• Research & Development
• QA/ QC
• Post Market Surveillance/ Vigilance

[Agenda] Medical Device Regulations & Compliance Summit 2022

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.