Following a meeting to discuss the specifics relating to the new MDR regulations, the MHRA has written a letter to clarify some key issues.
Namely:
- General Safety and Performance Requirements must be adheared to (similar to MDD)
- A Quality Management System must be in place (ISO 13485 strongly recommended) but does not have to be externally certified
- Registration with MHRA as a manufacturer of medical devices is not necessary
The letter can be accessed below
No comment
