The New MDR
The New MDR, just came into force on 25th May 2017, and while some businesses are taking their time mulling over the exact implications of the regulation others have taken a proactive approach, beating the mad rush which will eventually take place when the dust settles.
The MDR will have a major impact on Notified Bodies (NB’s) due to the strict demands from them, it is thought that this will sift out several NB’s literally making this a survival of the fittest situation. The reduction in NB’s will place heavy burden on those remaining and as a knock on effect this will cause longer timelines for products to reach market and potentially phase out of some production lines which may not be so cost effective in the European market.
The take home message here is don’t delay your Gap Analysis of the MDD to the MDR. The infographic here summarises some changes and the timeline. Let Pharmi Med Ltd. perform this for you.