Written by Regulatory IVD consultants TszWai Woo and Fiona Thompson of IVDeology Ltd
16th February 2023 saw the EU Parliament has voted in favour of the European Commission’s proposed MDR/IVDR amendment. Finally, an update!
The main impact for the IVDR is that the ‘sell-off’ period for existing IVDD products, previously specified in IVDR Article 110(4), has been removed. This means that IVDD devices already legally placed on the market can continue to be made available beyond 27 May 2025. This also applies to the MDR Article 120(4).
In addition, for the MDR, the transition period has been extended to end of 2026/2027/2028, subject to certain conditions and depending on the risk classification of the device. This means that the validity of MDD certificates can be extended, providing a formal application for an MDR conformity assessment has been submitted to a notified body by 26 May 2024, with a notified body contractual agreement by 26 September 2024.
The proposed amendment still needs to be adopted by the European Commission and published in the Official Journal, when this amendment will then enter into force.
This is welcoming news for the medical device industry as it will allow continued supply of safe devices on the market.
This opportunity is going to benefit manufacturers who have already started actively taking steps towards achieving MDR/IVDR compliance and eyes should not be taken off the ball…
Written by Regulatory IVD consultants TszWai Woo and Fiona Thompson of IVDeology Ltd