A proposal for amending Regulations (EU) 2017/745 (EU MDR) and (EU) 2017/746 (EU IVDR) has been published by the European Commission (EC) on 23 January. The European Commission propose a gradual roll-out of the European database on medical devices (EUDAMED), obligations in case of supply interruption, and transitional provisions for certain in vitro diagnostic medical devices (IVDs).
This proposal includes:
1. Transition of devices to IVDR: The EC is proposing more time for companies to apply the EU 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.
The new dates are subject to a number of conditions, including a signed agreement with a Notified Body approximately 2 years before the new deadlines. This grants additional time to go through conformity assessment but should not be used by IVD manufacturers to further delay their transition planning for IVDR transition.
It should also be noted that IVD manufacturers are expected to put in place a Quality Management System built in accordance with the IVDR by the 26 May 2025.
2. European database on medical devices (EUDAMED): Under the current provisions, the use of EUDAMED will only become mandatory when all modules function correctly. With this proposal the EC 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 starting from late 2025.
3. New requirements 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. Manufacturers are required to notify authorities and supply chain/customers at least 6 months in advance about interruption in supply of a device, where it is reasonably foreseeable that this interruption could lead to (risk of) serious harm to patients or public health. This is to help customers and authorities anticipate and manage shortages.
Next steps: This proposal will now be put forth the European Parliament and Council for adoption.
BIVDA recognise the impact of these proposals and will host a briefing session for members in the near future. Full details will follow shortly.
In the meantime, if you have any questions on the proposal or how it might impact your organisation, please send these to Regulatory@bivda.org.uk.