Following increasing pressure from industry and patient groups alike, yesterday (14 October) the European Commission published its proposal to delay the application of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) by amending the transitional provision. The Commission noted that the COVID-19 pandemic has hampered the capacity of Member States, health institutions and companies to comply with the new requirements in time for the current deadline of May 2022, and that the "serious shortage of notified body capacity, mak[es] it impossible for manufacturers to conduct the legally required conformity assessment procedures in time". As such, the proposal provides industry and patients some much needed relief, and aims to avoid a large number of products that are already on the market being discontinued in May due to non-compliance.
While the proposal still needs to go through the EU legislative procedure, it seems likely that the amendment will be adopted before the current date of application of May 2022. It is also important to note that the delay does not apply uniformly to all IVDs, as set out below.
Current state of readiness
Earlier this month, MedTech Europe published the outcome of its survey of members on the expected availability of IVDs after the date of application of the IVDR in May 2022. The response was worrying, but not unexpected given the increasingly urgent reports from industry of the amount of work that needs to be completed before the date of application, and the limited capacity of notified bodies to do so. The report noted that at least 22% of IVD tests on the market today are expected to be discontinued in any event, but that number could be substantially higher if no urgent solutions were found to address the current deadline for compliance – it was noted that 88% of IVDs did not have a CE mark certificate in July, meaning they could not be marketed under the IVDR.
The IVDR applies from 26 May 2022. However, transitional provisions apply whereby IVDs that are currently on the market by virtue of a certificate from a notified body can continue to be on the market until the certificate expires or until May 2024. However, the Commission notes that under the current Directive 98/79/EC on IVD medical devices (IVDD), only around 8% of all IVDs on the market are subject to notified body oversight and so can benefit from this provision. In contrast, under the IVDR, it is expected that this number increases to around 78%. Given only 6 notified bodies have been certified under the IVDR, this has caused huge capacity problems for manufactures, and MedTech Europe reported that 53% of manufacturers do not have a notified body to even be able to start the certification process.
The Commission Proposal
To provide more time for products to comply with the new rules under the IVDR, the proposal amends the transitional provisions in the Regulation to allow for a "progressive rollout". This is not a delay to the date of application of the IVDR, which remains May 2022. However, the length of the proposed transitional period has been extended, depending on the classification of device as follows:
|Class of IVD||Proposed date of application|
|IVDs with a certificate under the IVDD||May 2025|
|D (such as HIV or hepatitis tests) – 4% of the market||May 2025|
|C (including companion diagnostics and self-testing IVDs) – 25% of the market||May 2026|
|B – 49% of the market||May 2027|
|A (sterile) – 0.01% of the market||May 2027|
|A (do not require notified body certification) – 20% of the market||May 2022 (no change)|
|"In-house devices"/ "Laboratory developed tests"||Various (different provisions apply at different times)|
|New devices not on the market under the IVDD||May 2022 (no change)|
As with similar amendments that were made to the Medical Device Regulation in April 2020, the transitional provisions will apply provided the devices satisfy certain conditions, including that they continue to comply with the IVDD and that there are no significant changes in their design and intended purpose. In addition, certain provisions of the IVDR will apply in May 2022 in any event, such as the requirements relating to post-market surveillance and vigilance. The Medical Device Coordinating Group has prepared guidance under the Medical Devices Regulation to help understand some of these provisions. Manufactures will therefore need to determine what classification of IVD their products fall into, and consider how to comply with these additional provisions from May 2022.
A word on Brexit
Following the UK's departure from the EU, the IVDR will not apply in Great Britain and this proposal is not relevant to the supply of devices in this territory. However, the MHRA is currently consulting on the framework for medical devices that should apply in the UK, and has recognised that gaining and maintaining competitiveness in a global market is best supported by alignment with international standards, including the IVDR. The IVDR, and any amendment to it, will apply in Northern Ireland.
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