Going from around 80 to 20 or less Notified Body will be a drama for many companies, but I am sure a lot still don’t know that. If it’s not on the list you are in trouble. In July 2019, we should have the names of the confirmed Notified Bodies and to be honest with you I hope for you that your Notified Body is on the list. This PPT will provide you some KPI on the different audit performed and planned for MDR and IVDR. On October 9th, 2018, the European Commission published a status of the situation called “State of play of joint assessments of Notified Bodies in the Medical Device Sector”. Not all of them were able to provide that on-time. On November 2017, Team-NB mentioned that around 26 Notified bodies for MDR and 7 for IVDR applied to be certified. Please subscribe to my Youtube channel.īut something that we didn’t tell you is the fact that in reality, this transition timeline was initially for the Notified Bodies. These groups should help your company to define the strategy.īelow is a Video that will help you to get a high-level MDR Transition training. If you are outside or Europe, you should contact your Authorized Representative ( Here is an article about it). If you have a Regulatory Affairs Department or Regulatory Compliance group, please share with them this article (Share it also with your followers on social media). I am even updating this article every week as I am always discovering new information or new questions. The most important thing is for you to start now and not put that for later because you don’t have all the pieces of the puzzle. I will also provide you with some strategies that you can implement in your company.
The objective of this article is to help you to find your way with all the information you can receive. Those new regulations are coming soon into effect so let me tell you, what you should expect.
If you tell me No, then I inform you that you are maybe in trouble. Are you aware of the transition timeline for the new Medical Device (EU MDR) and In-Vitro Diagnostic Regulation (EU IVDR)?