Today (23-Jan) the European Commission has published a Proposal for “Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices”
IVDR Extension:
The European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. Under the current provisions, the IVDR rules would apply from 26 May 2025 for high risk IVDs or 26 May 2027 for lower risk IVDs.
The additional time granted to companies depends on the type of device:
• High individual and public health risk devices such as HIV or hepatitis tests (class D) would have a transition period until December 2027;
• High individual and/or moderate public health risk devices such as cancer tests (class C), would have a transition period until December 2028;
• Lower risk devices (class B such as pregnancy tests and class A sterile devices such as blood collection tubes), have a transition period until December 2029.
EUDAMED:
• Under the current provisions, the use of EUDAMED will only become mandatory when all modules function correctly.
• With this proposal the Commission is proposing to allow the gradual implementation of EUDAMED modules as soon as they have been audited and declared functional.
• This will allow the mandatory use of several modules to start from late 2025.
Additionally Article10(a) of MDR and IVDR has been amended with Obligations in case of interruption of supply of certain devices.
The proposal requires manufacturers to give prior notice if they foresee the interruption of supply of IVDs or medical devices, so that Member States have more time to take action.
The Proposal will now be put forward to the European Parliament and Council for adoption.
The commission has also simultaneously released the following:
Press release: https://lnkd.in/eB-3hgKp
Q&A: https://lnkd.in/epA9QaNK
Factsheet: https://lnkd.in/ehR3DxPb