Speaking at the Charing Cross Symposium 2019, Jeffrey Jump (Nyon, Switzerland), outlines the impact of the Medical Device Regulations (MDR), which he believes will be “the most devastating thing to happen to European healthcare in Europe since World War Two”.
Patients “will bear the brunt of this hardship” says Jump, who add that as well as regulating new products, the MDR will mean all existing products will have to go through re-certification which will be a “huge drain” on the notified bodies.
The regulations will have more than half of existing products removed from the shelf, according to Jump, who says that everyone will go to the US or Asia instead as a result.
Jump outlines that he would like to see the current deadline extended and give more time for existing products to “take a bit of pressure off the system”. He also outlines that he would like to see an innovation “fast-track for innovative products”.