EU Commission Publishes Updated Draft EUDAMED Timeline
12 July 2024
New Template Available: IVDR Transition Compliance Statement for IVDD Legacy Device Manufacturers
19 July 2024- Overview of IVDR Transition Guide
- Which devices can benefit from the extended transitional period?
- Is the transition period applicable if I do not intend to apply for CE Marking under the IVDR?
- How can I demonstrate that my legacy device benefits from the extended transition period?
- What is the impact of manufacturer or device changes during the transitional period?
- Do legacy devices have to comply with UDI requirements?
- Other Questions
- Updates to MDR Q&A Transition Document
- Further Reading
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.
Overview of IVDR Transition Guide
A sampling from the IVDR Transition Q&A document is provided below. Please read through the entire document for fuller understanding the requirements.
Which devices can benefit from the extended transitional period?
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.
Is the transition period applicable if I do not intend to apply for CE Marking under the IVDR?
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.
How can I demonstrate that my legacy device benefits from the extended transition period?
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:
- A self-declaration statement.
- It will attest that the device meets the IVDR extension conditions and applicable deadlines, e.g., IVDR-compliant QMS, lodging an application and signing an agreement with a Notified Body.
- A standardized template is expected to be available in the near future. It will likely be similar to the MDR transition self-declaration template already available (see here).
- The declaration should clearly list the devices eligible for the extension and any applicable IVDD certificates.
- It will attest that the device meets the IVDR extension conditions and applicable deadlines, e.g., IVDR-compliant QMS, lodging an application and signing an agreement with a Notified Body.
- A confirmation letter issued by your Notified Body.
- It will confirm the devices have met the applicable deadlines to lodge an applicable and sign an agreement.
- There is a standardized template available for Notified Bodies to use, however it is currently drafted for the MDR. Expect an IVDR version to soon be issued.
- The Commission states this could “be issued, in principle, without extra costs”. However, some Notified Bodies may charge for time used, or an administrative fee.
- It will confirm the devices have met the applicable deadlines to lodge an applicable and sign an agreement.
- Obtain a Certificate of Free Sale (CFS).
- It will list the extended validity period.
- The EU Competent Authority may request the above prior to issuing the CFS.
- The validity date will be based on your compliance at the point of request, i.e., if requested today, it may be issued only until 26 May 2025 if you have not yet implemented an IVDR compliant quality system; or only through the deadline to lodge an application with a Notified Body.
- It will list the extended validity period.
What is the impact of manufacturer or device changes during the transitional period?
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.
Do legacy devices have to comply with UDI requirements?
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.
Other Questions
The document addresses additional questions, such as:
- Which evidence does the manufacturer have to provide for having put in place a QMS in accordance with the IVDR?
- What are the necessary elements of a formal application lodged by the manufacturer?
- What are the necessary elements of a written agreement between the manufacturer and the notified body?
- What is the meaning of “device intended to substitute that device”?
Updates to MDR Q&A Transition Document
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.”
Further Reading
You may also be interested in the following topics:
