Getting Ready for EU MDR/IVDR Device Certification & Recertification: Updates & Implications for Manufacturers
Tue. February 5| 1:15 PM - 3:00 PM | 210D
Show: MD&M West 2019
Track: MD&M West: Regulatory & Quality Update
Badge Type: Paid
By May 26, 2020, medical device manufacturers active in Europe must be fully compliant with the new EU Medical Device Regulations. The countdown to the MDR/IVDR's date of application (May 26, 2022) has also begun. These significant changes are increasing the pressure on manufacturers to comply to keep products on the market. In this session, we'll discuss the current status of the EU MDR/IVD regulations and explore compliance challenges for industry.
Topics covered include:
- What significant impacts will medical device manufacturers see on their current business?
- Performing product portfolio assessments – is it cost-effective to recertify?
- Effect on IVD companies who are now 80% under direct review by Notified Bodies
- A practical checklist and a suggested timeline will be provided for manufacturers
