The EU Commission published a Q&A document on the ‘practical aspects’ of the IVDR extended transition period, newly granted under Regulation 2024/1860. It is available here.
Further, the MDR transition Q&A was updated to align with the IVDR transition Q&A. It was originally published in March 2023, and this is its 3rd revision. It is available here.
A sampling from the IVDR Transition Q&A document is provided below. Please read through the entire document for fuller understanding the requirements.
The extension only applies to legacy devices. It is not applicable to any devices new to the European market, i.e., devices that did not have valid IVDD CE Marking on 26 May 2022.
Further, legacy devices must meet the deadlines outlined in Regulation 2024/1860, which start as of 26 May 2025. By this date, all legacy IVDs must implement an IVDR-compliant quality system and class D devices must have lodged an application with a Notified Body. The deadlines for Class A sterile, B, and C IVDs are outlined here.
For a shorter period of time, yes.
If a manufacturer has IVDD CE Marking for a legacy device, then they may utilize Regulation 2024/1860 to continue marketing until 26 May 2025. During this time, the manufacturer must continue to comply with the certain IVDR requirements, including those related to post-market surveillance, vigilance, registration, etc.
However, after 26 May 2025, all manufacturers must have implemented an IVDR-compliant quality system in order to continue marketing. And they must meet each individual deadline to lodge an application with a Notified Body. The full compliance dates are here.
Third parties (e.g., customers or customs brokers) may request evidence that devices are compliant with the transitional provisions. The evidence that manufacturers can provide include:
Administrative changes are possible during the transitional period. This includes changes to the manufacturer’s address, changes due to a merger or acquisition, or change of your European Authorized Representative.
However, significant changes to the design or intended purpose of the device cannot be made to the legacy device. Doing so may require IVDR compliance prior to marketing with that change.
Please refer to MDCG 2022-6 for guidance on significant versus non-significant changes.
No, even though ‘legacy devices’ are required to comply with IVDR QMS requirements by 26 May 2025, they are not required to comply with the IVDR UDI requirements.
Article 10(8), point (h), IVDR states that verification of UDI assignments to all relevant devices is required as part of the QMS. However, the key point is that it only applies to ‘relevant’ devices, i.e., devices that are CE Marked under the IVDR.
The document addresses additional questions, such as:
The MDR Transition Q&A document was updated to align with the recently released IVDR Transition Q&A guide. Some updates include:
Addition of question 11.1: Do all QMS aspects listed in Article 10(9) MDR have to be addressed?
“In principle, yes. However, for some specific QMS aspects listed in Article 10(9) MDR, e.g. points (b), (e) and (f), it needs to be taken into consideration that the QMS covers ‘legacy devices’, i.e. devices that are not yet (fully) MDR compliant.
That means that for those devices it is not required that manufacturers have identified all relevant general safety and performance requirements and options to address those requirements, or have put in place a risk management as set out in Section 3 of Annex I MDR, nor conducted a clinical evaluation in line with Article 61 and Annex XIV MDR. However, from 26 May 2024, the manufacturer’s QMS should address how compliance with those requirements will be achieved.”
Addition of last paragraph to Question 13: What are the necessary elements of the arrangement for the transfer of the surveillance from the notified body that issued the MDD/AIMDD certificate to the MDR notified body?
“Reminder: Appropriate surveillance in accordance with Article 120(3e) MDR only applies to legacy devices that are covered by a certificate issued by a notified body in accordance with the MDD/AIMDD. This also applies to devices covered by an MDD/AIMDD certificate that had expired and that is considered valid because the conditions set out in the second subparagraph of Article 120(2) MDR are met; in those cases, the appropriate surveillance has to be resumed.
Legacy devices for which the conformity assessment procedure pursuant to the MDD did not require the involvement of a notified body (‘self-declared’ devices under the MDD), but that require the involvement of a notified body under the MDR, are not subject to surveillance by a notified body pursuant to Article 120(3e) MDR.”
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