The proposed changes
In a recent announcement, The European Commission, outlines plans to extend the medical device transitional period. These changes refer to “Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)” and varies depending on the different product classes.
Under the proposal, the transition period deadline would be extended to 31 December 2027, or 31 December 2028, depending on the risk class of the device.
The new proposed dates are:
- 2027 for Class IIb and Class III products
- 2028 for Class IIa and Class I
What sparked these changes?
These changes are planned amid concerns surrounding the “availability of medical devices on the EU market”.
Although much progress has been made to meet existing conformity targets, current consensus dictates:
- Firstly, that “the overall capacity of conformity assessment (‘notified’) bodies remains insufficient to carry out the tasks required of them” and,
- Secondly, “many manufacturers are not sufficiently prepared to meet the strengthened requirements of the MDR by the end of the transition period”.
This poses a challenge to supply and demand because “after the expiry of the certificates issued under the Directives and without a valid MDR certificate, manufacturers are no longer allowed to place these medical devices on the EU market. This may cause shortages of medical devices, putting patient safety at risk”.
What does this mean for device manufacturers?
As a manufacturer or supplier of medical or in-vitro diagnostic devices, this delay will provide more time to ensure that your devices meet the appropriate UDI regulatory requirements, while providing extended time to register devices and apply for certificates.
GS1 are authorised as a code issuing entity for medical device regulation in the EU. As such, we are well equipped to support members with using GS1 standards to comply with applicable UDI requirements.
We will continue to provide you with any help and information you might need throughout the transition period and have a host of materials and resources available.
Get in touch or explore our resources below for support.
