Enforcement of the EU MDR was scheduled for May 2020, which would require all submissions for CE marking or renewal to comply with the new regulation. In the years leading up to the deadline, companies have been urgently preparing for the transition through remediation of their files, conducting newly required testing, and screening for CMRs. Then, as SARS-COV-2 spread throughout the globe, a pandemic was declared, and submissions were stalled. The EU responded by extending the deadline for compliance by 1 year. This presentation, co-presented by a medical device manufacturer and a laboratory will discuss strategies for MDR remediation and lessons learned through the process so far with the aim of helping others avoid common pitfalls.
- Brief overview of key changes in the new MDR and updated timeline
- Industry experience of MDR remediation process
- CRO experience of MDR remediation process at interface of sponsors and notified bodies
Presenters: Jennifer Braunschweig, MS – Engineering Director, Medtronic; Matthew R Jorgensen, PhD, DABT; Senior Chemist and Toxicologist, Nelson Labs