Commission Seeks To Extend Delegated Act Powers By Five Years Having Not Used Its Powers Yet
The European Commission has issued a report in a move intended to extend its powers to amend the MDR and IVDR in places where the text of the regulations allow this.
You may also be interested in...
Provision of electronic instructions for use for devices is now a well-established practice. But there are conditions. A new Implementing Regulation explains how these apply under the Medical Device Regulation.
With the EU’s Employment, Social Policy and Consumer Affairs Council due to discuss solutions to the MDR crisis on 9 December, the European Parliament is calling for risk-related deferrals.
The EU is in urgent need of more notified bodies to test medtech products under the Medical Device and IVD Regulations. The commission is taking steps to free up everyone’s time.