IVDR extended transition period: What it means for IVD manufacturers

The content of this article (originally published on 18 October 2021) has been updated to reflect legal changes as at April 2023.

On 25 January 2022, the EU Regulation 2022/112 was published in the Official Journal of the European Union, making law the amendment to Regulation (EU) 2017/746 (IVDR). This extended the time periods for certain IVDs to continue to be placed on the market and made available under Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD), depending on certificate status and classification of the IVD. IVDR remains fully applicable since 26 May 2022, but the transitional period for obtaining certificates and placing IVDs on the market has been extended. The extensions depend on whether an IVD has a certificate under IVDD and/or whether they require one under IVDR. The dates by which health institutions are to meet their new requirements for exemption have similarly been extended.

In a later piece of amending legislation the EU Commission has removed the cut-off date for making IVDs available on the market. This means that the shelf life of the product will determine when the IVD can no longer continue to be sold, used, or otherwise made available in the EU.

The necessity for an extension

The reasons given for the extensions include the notified body bottleneck, caused by:

• the pandemic causing delays in conformity assessments by notified bodies
• the change from 8% to 80% of IVDs requiring notified body certificates
• the time to complete the assessment (one year plus six months to manufacture prior to release to the market)
• the lack of notified bodies (only six currently designated).

The EU Commission has recognised the potential for IVDR to cause significant disruption in the supply of IVDs and has listened to the increasingly loud clamour for an extension from across healthcare providers and industry.

Extensions to transitional provisions for IVDs

Actions on IVDD certificates

Manufacturers with certificates that have already been issued under IVDD with the shorter end date of 26 May 2024, now extended to 26 May 2025, should ask their notified body to provide confirmation that their certificate is extended.

Note that no significant changes in the design and intended purpose might be made during the transition period. If significant changes are necessary, the IVD manufacturer will need to progress obtaining the IVDR certificates sooner than the time otherwise permitted by the extension.

The notified body issuing the IVDD certificate remains responsible for appropriate surveillance, and continued dialogue should be maintained with them as usual, even if a different notified body will be used to obtain a certificate under IVDR.

Applicability of IVDR despite transition period

Manufacturers should note that even if they are able to take advantage of transitional provisions, they must still comply since 26 May 2022 with IVDR provisions on post-market surveillance, market surveillance, vigilance, and registration of economic operators and of devices. Foreign manufacturers will also need to have appointed an importer since 26 May 2022.

Note also that if a device does not have a declaration of conformity for the intended purpose of the particular IVD dating from before 26 May 2022, they cannot take advantage of the transitional provisions and must obtain a certificate from a notified body under the IVDR before their IVD is placed on the EU market.

Health institution exemption

Article 5(5) IVDR introduces new requirements for health institutions to be exempt from many requirements applicable to other IVD manufacturers. Implementation of those requirements (save only that devices are not transferred to another legal entity) is proposed to be postponed to 26 May 2024. The postponed requirements on health institutions relying on the exemption include:

• having an appropriate quality management system
• compliance with either EN ISO 15189 or applicable national provisions, including accreditation
• the ability to provide the competent authority with justification of their manufacturing, modification and use of these less regulated devices
• the declaration of meeting the General Safety and Performance Requirements (GSPRs) under Annex I IVDR
• for class D devices, drawing up detailed documentation about the manufacture, design and performance data, to allow the competent authority to ascertain compliance with GSPRs and taking measures to ensure IVDs are manufactured accordingly
• review of experience and taking corrective action as a result.

Health institutions will not be required to justify the use of these exempted IVDs for the target patient group's specific on the basis that patient needs cannot be met or met at the appropriate level of performance by an equivalent device until 26 May 2028.

These extensions will allow health institutions much longer to change their sourcing model for their 'home brew' IVD tests and are an indication of how pervasive the use of the health institution exemption is within healthcare institutions in Europe.