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Optimizing PLM-OEM Collaborations: Key Strategies for a Smooth IVDR Transition
Under Directive 98/69/EC (IVDD), it was common practice for in vitro diagnostic medical devices to be placed on the European market under...
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Joana Gomes : Jan 26, 2024 5:42:50 AM
On 23 January 2024, the EU Commission published a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring availability of safe devices that are essential for healthcare systems. With this proposal, the EU Commission is proposing to extend transition periods for certain IVDs (legacy devices and in-house devices) subject to fulfillment of certain conditions, gradual roll out of EUDAMED, and introducing a new obligation for manufacturers to give a prior notice in case of disruption of supply.
We welcome the proposal put forward by the commission and are looking forward to it being adopted by parliament and published in the official journal.
As 80% of the IVDs under IVDD are self-certified (i.e., no involvement of a notified body in the conformity assessment process) we would like to share our thoughts with IVD manufacturers, which are up-classified and require involving a notified body under IVDR.
If this proposal is adopted (we believe it most likely will), devices for which the conformity assessment procedure under Directive 98/79/EC did not require the involvement of a notified body (up-classified devices) will benefit from longer transition periods provided certain conditions are met. The proposed transition periods are:
Only ‘legacy devices’ (as defined in MDCG 2022-8) may benefit from extended transition periods if they fulfill the following conditions:
It’s important to note that manufacturers of legacy devices can benefit from longer transition periods only when the above-mentioned conditions are met, and these conditions would have a direct impact on the transitional effort.
The Takeaway
Although extending transition periods based on device risk classes supports a better implementation of the regulation and gives adequate time for the industry to prepare for the transition, we strongly encourage IVD manufacturers to continue their transitional efforts without any pause!
Our regulatory team is ready to support you in ensuring you handle all the changes and requirements in the most efficient way.
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