What is the new MDR, and what are the key differences between it and the MDD?
The MDR will replace the MDD and it applies to all medical device manufacturers who have goods for sale on the European market. It is important to note that no existing requirements have been removed from the MDD, but the MDR does add new requirements, for example:
- Expansion of the scope of products covered
- Reclassification of devices according to risk
- More rigorous requirements for clinical evidence and evaluation
- Mandatory implementation of unique device identification measures
- Increased post-market oversight by EU notified bodies.