The Medical Devices Regulation (MDR) and In Vitro Medical Devices Regulation were published in the Official Journal of the European Union on 5 May 2017 and entered into force on 26 May 2017.
Now in the 3 year and 5 year respective transition periods these regulations aim to better protect public health and patient safety by increasing the pre- and post-market scrutiny of medical devices on the European market.
During these transition periods, products can be placed on the market if they comply with either these new regulations or those they are intended to replace.
PAGB’s work on the MDR as it applies to products in the scope of our membership is coordinated through the Medical Devices Regulatory Group.
For medical device products to be within scope of PAGB membership they must;
For more information on which devices fall into scope of PAGB membership please contact email@example.com