Due to the one-year postponement of date of application of the Medical Devices Regulation (MDR), the grace period available for manufacturers to switch from the current legislation to MDR has been shortened from 4 to 3 years.
Therefore, and being aware of the increased workload this implies, the Team-NB members’ recommended on medical device manufacturers and other stakeholders to pursue their original plans for this transitioning as much as possible under the given circumstances.
Asphalion closely follows news and movements around the new MDR and IVDR to better assess manufacturers and stakeholders on their implementation. If you have questions on MDR implementation do not hesitate in contacting us at firstname.lastname@example.org.
We are here to help you!