The European Commission is proposing to give more time to certain IVDs to reach IVDR compliance!

The European Commission (EC) has presented a proposal to amend the timeline of the future In Vitro Devices Regulation 2017/746 for certain IVDs.

More specifically, the EC wishes to extend the transitional provisions of IVDR Article 110(3) to enlarge its scope as well as to prolong validity of IVDD Certificates for 1 year. Moreover, the existing transitional period for devices covered by a valid CE IVDD Certificate are to be extended by 1 year, until 26 May 2025. Additionally, the devices with an IVDD Certificate can be made available or put into service for longer than originally envisaged by the IVDR – until 26 May 2026 [originally fixed at 26 May 2025].

Yet, the biggest change concerns the devices that were ”up-classified” by the IVDR.

As Notified Bodies are experiencing limits on their capacities to provide certification to all the required IVDs, this proposal aims to avoid shortages on the supply of In Vitro Diagnostic devices amid the COVID-19 pandemic. Thus, manufacturers of IVDs that will need the involvement of a Notified Body for their device conformity assessment procedures under the IVDR (an estimated 80% of the IVDs) would enjoy more time to be fully IVDR compliant.

Therefore, the European Commission proposes to extend the transitional periods of placing on the market of IVDs to the following dates:

  • 26 May 2025 for class D devices [can be made available or put into service until 26 May 2026]
  • 26 May 2026 for class C devices [can be made available or put into service until  26 May 2027]
  •  26 May 2027 for class B devices [can be made available or put into service until 26 May 2028]
  • 26 May 2027 for class A devices placed on the market in sterile condition [can be made available or put into service until 26 May 2028]

Nonetheless, these devices should continue comply with the IVDD and respect certain IVDR provisions as of 26 May 2022. It is important to note that no significant change to design or intended purpose can occur to benefit from the additional time. Please bear in mind that full compliance with the IVDR should be achieved at the latest by the above dates highlighted in bold.

Example:

    1. An IVD, which is Annex II list B under IVDD with a valid NB Certificate: under the proposed IVDR, it can be placed on the market until 26  May 2025.
    2. An IVD which is a self-certified device/All others under IVDD and becomes Class C under IVDR, it can continue to be placed on the market until 26 May 2026.

Moreover, the European Commission has also extended this proposal to In Vitro Diagnostic Devices that are manufactured and used within the same health institution (the so-called “in-house devices“) with date of application of the IVDR being moved to 26 May 2024 and 26 May 2028.

Nevertheless, please note that these delays on the application date should not be taken for granted. In words of Stella Kyriakides (Commissioner for Health and Food Safety): “I call on all manufacturers to prepare for certification under the new Regulation as soon as possible and not wait until the end of the transition period”. In addition, to provide greater clarity on this proposal, the European Commission has also released a Q&A document on the progressive roll-out of the new IVD Regulation.

Please kindly note that this proposal does not affect IVDs that do not require a Notified Body involvement under IVDR or “new” IVDs. For these devices the date of application would still be 26th of May 2022.

In order for this proposal to come into effect it would need to be approved by the European Parliament and the Council, to where it has been sent for adoption.


All documents are available in our dedicated IVDR Library of documents!


REFERENCES:

https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5209

https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_5210

https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/md_2017-746-regulation_2021-amendment_en.pdf

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