EU legislation to introduce a new regulatory system for general medical devices (the Medical Devices Regulation) was to have taken effect from 26 May 2020. However, a delay of 12 months was thought appropriate to reduce pressure on regulators and businesses, and to avoid the interruption of medical equipment supply chains, during the current crisis.
Delaying legislation in the form of a short amending Regulation has passed through the necessary procedures at lightning speed. The new system will become mandatory for general medical devices from 26 May 2021.
As well as putting back the date for full roll-out of the new system, the legislation provides support for emergency approvals of products necessary for combating the pandemic.
For further information, head over to our sister blog, Life science law.