The new law to guarantee the safety of medical devices for patients and users within the European Union and to prevent the use of improperly functioning devices within healthcare.
From MDD to MDR
Last week was an important week for medical device manufacturers. The MDR became applicable and has replaced the MDD. Meaning, from now on, if you want to place a new medical device on the European market you must comply with the MDR.
Being significantly more comprehensive and detailed compared with its predecessor, the new European MDR stimulates a life-cycle approach to medical device regulation. And is instead less focused on the pre-approval stage of medical device manufacturing.
The new regulations encourage policies and procedures that elevate the responsibilities of medical device companies for their products throughout the product lifecycle.
And that’s not all. Next year this time, May 26th 2022, will come for in vitro diagnostic device manufacturers. For most of them this is an even bigger challenge than for the medical device manufacturers as they have never had contact with a notified body before.
Want to know more?
Wonder how you become compliant with the new regulations? Or do you want more information about the changes that have taken place? Research in a timely manner whether your innovation is considered a medical device.
The MedTech team at Holland Innovative is always available for help. We can help identify what needs to be changed and guide you through the successful implementation of these changes. Feel free to reach out to one of our colleagues for more information.