Medical Device Regulation (MDR), 2017/745 comes into force 26 May 2021. The new legislation will change the life of every actors who are part of the supply chain of medical devices.
Is your business ready for May 26, 2021? AlfaNordic can review the quality system and product portfolio and provide a way to meet the new requirements. We can also help with the work or the project management.
MDR should be on the agenda of all organizations involved in medical devices: manufacturers, representatives, importers and distributors. There are also products that under MDD were not medical devices, but will be medical devices under MDR!
In addition to gap analyzes, AlfaNordic can develop the MDR implementation strategy to make the best use of the transitional arrangements. We can also be responsible for the project management and not least implement the changes in the organization. Without proper implementation you will fail your next audit, as MDR has a much greater focus on implementation compared to MDD.