On January 6th, 2023, the European Commission (EC) adopted a proposal to extend the already existing transitional period for legacy devices under the MDR. The goal of this extension is to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework under MDR. This proposal not only impacts medical devices but also IVDs as for both MDs and IVDs the sell-off period is removed. This proposal is now also approved by the European Parliament under accelerated procedure, which means the proposal should enter into force very soon!
Transitional provisions for certain medical devices and in vitro diagnostic medical devices
Removal of the sell-off period
The original IVDR article 110 point 4 stated that “Devices lawfully placed on the market pursuant to IVDD 98/79/EC prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025”. The amending regulation 2022/112 which was published December 2021 introducing new transitional provisions under the IVDR introduced new “sell-off” provisions for the devices up-classified to Class A sterile, B, C or D. For these devices, the sell-off provisions were extended to 26/05/2026 (class D), 26/05/2027 (class C) or 26/05/2028 (class B and class A sterile). So, self-declared devices under the IVDD 98/79/EC that are future IVDR 2017/746 class A sterile, B, C or D devices that have been legally placed on the EU market prior to the date of application of the IVDR 2017/746 for up-classified devices as introduced by the amending regulation on transitional provision (26/05/2025 (class D), 26/05/2026 (class C) or 26/05/2027 (class B and class A sterile)) may continue to be made available on the market or put into service until 26/05/2026 (class D), 26/05/2027 (class C) or 26/05/2028 (class A sterile and B).
This new proposal will once again amend Article 110 point 4 so that in the future it will state the following: “Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022, and devices lawfully placed on the market from 26 May 2022 pursuant to paragraph 3 of this Article may continue to be made available on the market or put into service.”
If you combine all the information this means that if you placed an IVDD compliant device on the market prior to 26/05/2022, or if you placed devices on the EU market after 26/05/2022 making use of the transitional provisions, the deadlines to comply to the IVDR are not changed, however all devices that were legally placed on the EU market before those deadlines (26/05/2025 (class D), 26/05/2026 (class C) or 26/05/2027 (class B and class A sterile)) can continue to be made available to the market or put into service with no defined deadline. This allows you to sell-off the stock that you have until the device basically expires. If you would have a device with a 2-year shelf life that becomes a Class C device, then you could theoretically produce a big last batch and place these on the EU market prior to 26/05/2026 and you would be allowed to sell the devices from that batch until 2028 when they expire.
For medical devices the conditions as proposed on January 6th have been fully adopted, please refer to the earlier newsletter we send out on this topic.
What does this mean to you?
This amending regulation aims to decrease the risk of shortages for medical devices. For IVD manufacturers by removing the sell-off date you will not be allowed to place any devices on the market anymore that do not comply with the IVDR after the deadlines that were set with regards to the transitional provisions (26/05/2025 (class D), 26/05/2026 (class C) or 26/05/2027 (class B and class A sterile)) but you will be allowed to sell off all stock without an end date.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
