The European Parliament has adopted new rules on medical devices
In continuation of our Life Science Update on 17 March 2017, where we stated that the Council of the European Union had adopted the new EU rules on medical devices and in-vitro diagnostic medical devices, we can now state that the rules have also been adopted by the European Parliament. This was the last step on the way to a formal approval of the two regulations.
The regulations are expected to be published in the Official Journal of the European Union in May and, subsequently, there will be an implementing period of three years for medical devices and five years for in-vitro diagnostic medical devices.
We will keep track of the development, and before the final implementation we will focus on some of the new provisions, as well as the challenges and possibilities for companies and the effect of the new rules.
You can read the press release from the European Parliament here
You can read our previous Life Science Updates on the new regulations here