MDR vs. MDD: 13 Key Changes
Until today, medical devices were complying with the MDD to sell their products in Europe. However major amendments are made in the current MDD to keep up with the growing technological advances in healthcare and medical devices. The new regulations passed by the Council of the European Union is Medical Device Regulations (MDR) 2017/745 that came into force in May 2017 & manufacturers have a transition time of three years until May 2021 to comply with the new regulations.
As companies plan and execute their transition projects to bring their organizations into compliance under the new Regulation, it's important to be aware of all the major changes that will require planning and action.
Medical device companies are required to comply with various new / updated regulations of MDR. Many Class I medical device companies are now required to comply along with various products are reclassified and all legacy products are required to receive approval too.
Typically, all MDD-MDR Transition projects initiate with Gap Assessment. Gap Assessment is a crucial activity during MDR transition & our team with engineering & regulatory expertise are well equipped to conduct this activity with an analytical mindset, resolve any regulatory concern and develop robust regulatory strategy for medical device manufacturers.Â
