The final reveal of a much-discussed extension to the transition period for compliance with the new regulation on In Vitro Diagnostic Devices (IVDs) occurred on 14 October 2021, with the publication by the EU Commission of a proposal to amend Regulation (EU) 2017/746 (IVDR). The proposal allows longer transitional periods for In Vitro Diagnostic Medical Devices (IVDD) certificates, placing on the market and making available of IVDs under the current Directive 98/79/EC on IVDD, depending on certificate status and classification of the IVD. This is a proposal that is yet to become law and therefore remains subject to change.
IVDR will remain fully applicable from 26 May 2022 but the transitional period for obtaining certificates, placing on the market and making available, 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.
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 (1 year plus 6 months to manufacture prior to release to the market); and
- the lack of notified bodies (only 6 currently designated).
The EU Commission has finally 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.
Actions on IVDD certificates
Manufacturers with certificates that have already been issued under IVDD with the shorter end date of 26 May 2024, and which might now be extended to 26 May 2025 should ask their notified body to provide a new certificate with this longer date.
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 extended transition period.
The notified body issuing the IVDD certificate remains responsible for appropriate surveillance and continuous 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 from 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 appoint an importer from 26 May 2022.
Devices not requiring any notified body certificates and placed lawfully on the market prior to 26 May 2022 might continue to be made available or put into service until 26 May 2025. To be able to take advantage of this provision though, manufacturers will need to stock pile in the EU their devices that are "placed on the market" ahead of 26 May 2022.
Note also that if a device not requiring any notified body certificate under MDD does not have a declaration of conformity dating from before 26 May 2022, they cannot take advantage of the transitional provisions.
Health Institution Exemption
Article 5(5) IVDR introduces new requirements for health institutions to be exempted 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 needs 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.