The IVDR became fully applicable in the EU on 26 May 2022 and overhauls the existing regulatory regime provided for by the In-Vitro Diagnostic Medical Device Directive 98/79/EC (IVDD), which was repealed by the IVDR on 26 May 2022.
Meanwhile, the European Commission’s Medical Device Coordination Group (MDCG) has published various guidance documents specifically addressed to the requirements under the IVDR. The discussion around notified body numbers and capacity has gained momentum and updated transitional provisions have also been receiving increasing attention.
The MDCG has now published a large number of guidance documents addressing issues specific to the IVDR such as:
- Classification rules
- Transitional provisions
- The use of clinical evidence
- Notified body applications for conformity assessment
There are also a number of guidance documents that address both the MDR and the IVDR such as:
- EUDAMED registration
- Packaging and relabeling activities
- Persons responsible for regulatory compliance
There has been a surge in demand for conformity assessment services due to the revised classification rules set out in the IVDR. The criteria for organisations seeking accreditation as notified bodies has also become more stringent. This increase in demand coupled with stricter criteria has led to a decrease in supply of conformity assessment services. The European Commission, in its proposal extending the transitional periods notes that whereas under the IVDD only a relatively small number of high-risk devices (about 8% of all in vitro diagnostics on the market) were subject to notified body control, under the IVDR, approximately 80% of in vitro diagnostic medical devices will require the involvement of notified bodies, the vast majority of them for the first time.
By the time it was repealed, 22 notified bodies had been designated to provide conformity assessment services under the IVDD. Currently, there are only 7 notified bodies designated to provide such services under the IVDR. The MDCG has been aware of this issue for some time and again noted the issue of limitation in issue and capacity in its recently updated Joint Implementation and Preparedness Plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
The Competent Authorities for Medical Devices (CAMD) released a statement on 10 June 2022, where it recognised the risk of disruption to the supply of essential medical devices, and that access patients have to medical devices may be affected. The CAMD states that it is also aware of the deterrent effect this may have on innovation. It is working with the MDCG to “urgently seek and consider all potential solutions”.
However, the CAMD makes it clear that:
“derogations from conformity assessment issued by national competent authorities are not suitable as a general solution” and states that derogations are a matter of exception rather than a rule, “on the grounds of public health protection only rather than on the basis of commercial or market factors”. Derogations, the statement proceeds to underscore, cannot replace or substitute the assessment completed by notified bodies.
The European Commission, driven by the “grave shortage of notified body capacity” and COVID-19 restrictions “significantly hamper[ing] the proper conduct of conformity assessment”, issued a proposal (COM/2021/627) on 14 October 2021 to amend the transitional implementation periods under the IVDR, which was then confirmed and approved by the European Council and the European Parliament.
The new transitional periods introduced under the amendment to Article 110(3) of the IVDR apply to IVDs that:
- Do not currently require notified body involvement in the conformity assessment procedure under the IVDD, but will require this under the IVDR, and
- Have a declaration of conformity issued under the IVDD prior to 26 May 2022
The extended transitional period will depend on the class of the device:
- Existing higher risk class D and class C devices under the IVDD may be placed on the market or put into service until 26 May 2025 and 26 May 2026 respectively, and
- Existing devices classified as class B under the IVDD, and class A devices in a sterile condition, may be placed on the market or put into service until 26 May 2027
It is important to note that although these transitional provisions allow certain IVDs to remain on the market during the extended transitional periods outlined above, they must continue to comply with the IVDD from the date of application of the IVDR. They must not have any significant changes made in their design and intended purpose. These devices must also comply with the requirements of the IVDR relating to post-market surveillance, market surveillance, vigilance, and registration of economic operators.
An amendment to Article 110(4) of the IVDR reiterates that IVDs lawfully placed on the market under the IVDD prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025.