May 23rd – May 24th 2022
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!
PRACTICAL CASE STUDIES ON
- preparing your QMS for EU MDR, risk based decision making processes for effective QMS
- compliance for updated UDI, how will UDI requirements impact label content and designs
- reaching out to Notified Bodies early to meet their expectations, preparing for NB audits
- proactive Post Market Surveillance: streamlining PMS processes to meet shorter deadlines
- MDR requirements for biocompatibility, developing biocompatibility testing strategies
- smooth transition to new EU MDR, strategies to remediate gaps in clinical data and processes
- assessing classification changes and aligning product pipeline with MDR regulatory strategy
- connecting risk management with clinical evaluation and post-market surveillance under MDR
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