Tue, Dec 08|
Medical device & combination product safety update (1)
We are hosting our next GRIP event on 08-DEC-2020, from 15:00-17:00 CET / 09:00-11:00 ET. Medical device and combination product safety is moving fast and will in 2021 become a major concern across Europe, US And Japan. Join the meeting to learn more and discuss with peers.
Time & Location
Dec 08, 2020, 3:00 PM – 7:00 PM GMT+1
About the event
Benchmark on FDA Combination Products / similar device update:
- Have we implemented the same solutions and controls?
Getting ready for the EU Medical Device Regulation (MDR):
- What needs to be ready for PV by May 2021 and beyond?
Manufacturer Incident Report (MIR) status from the markets:
- Who is requesting them?
- In which formats are they requested?
- How has the first year of reporting worked?
In terms of other markets:
- Japan requirements in April 2021
- What is the MHRA up to after Brexit?
The session will be facilitated by Martin Holm-Petersen, CEO at Insife