As of October 14, 2021, the European Commission (EC) has issued a proposal for a modified rollout of the new In Vitro Diagnostic Regulation (IVDR). The IVDR requirements remain intact. However, the EC is proposing to extend the transitional period for in vitro diagnostics (IVDs) that need to undergo conformity assessment by a notified body (NB).
The proposal comes after mounting pushback against the original IVDR timeline. Many more IVDs need to undergo conformity assessment for the first time under IVDR. Where the previous In Vitro Diagnostic Directive (IVDD) guidelines required about 8 percent of the IVDs on the market to be NB certified, IVDR requires certification for 92 percent. With an influx of IVDs requiring certification and just six IVDR NBs in place, there has been increasing worry that the capacity of NBs will be unable to meet the demand for certification within the original timeline.
The substantial changes introduced by the IVDR raised NB capacity concerns when the new guidance was introduced in May of 2017. Since then, these concerns have been exacerbated by the COVID-19 pandemic, which caused unforeseen certification disruptions and a diversion of already limited resources.
The EC said the proposed changes to the timeline, which have yet to pass into law, aim to balance NB capacity with a high level of public health protection.
What has changed?
The transitional period for full IVDR certification, which applies to IVDs that were CE (Conformitè Europëenne) marked by the previous IVDD regulations, has been extended from the original May 2024 deadline for IVDs that require conformity assessment by an NB. This means that manufacturers of IVDs that need NB certification will have more time to get certified under IVDR, as long as they were certified by the IVDD guidelines before May 26, 2022. The length of transitional period increases with decreasing device class risk:
- Class D devices have until May 2025, a one-year extension
- Class C devices, including companion diagnostics, have until May 2026, a two-year extension
- Class B and certain class A devices have until May 2027, a three-year extension
- Class A devices that do not require NB certification still have until May 2027
The proposed transition period extensions will increase the number of devices certified by the IVDD that are sold after May 2022. However, companies that delay conformity assessment during the transition period may still need to comply with other aspects of IVDR after May 2022. Other transition periods apply to laboratory-developed tests.
What has not changed?
IVDR will still apply in full from May 26, 2022. New or significantly modified IVDs must meet the full requirements of the IVDR to be placed onto the market after May 26, 2022.
IVDR will apply to all Class A non-sterile IVDs from the date of application because they do not require NB certification to go to market. Class A non-sterile IVDs account for approximately 20 percent of the market.
What does this mean for development programmes using companion diagnostics?
Certified companion diagnostics (such as cobas braf assay, or FMI), which are class C devices, can be placed on the market until May 2026 under their existing IVDD certification — without needing certification under IVDR.
However significant changes to a companion diagnostic (such as introducing a claim for use of the companion diagnostic with a new drug) would require fulfillment of all IVDR provisions, including NB review.
If a development program includes new IVDs, which are not IVDD certified before May 26, 2022, the IVDR rules will apply from May 2022 onwards. This includes an IVDR-compliant device performance evaluation application prior to the start of the clinical trial.
Are the changes sufficient?
If the proposal is passed into law, the extended and staggered transition periods are likely to prevent a short-term certification backlog, and lessen the pressure on NB capacity by spreading out demand over multiple years.
However, while the EC has acknowledged that current NB capacity is insufficient, there are currently no proposals to bring more NBs online. Even spread out over several years, the workload for NBs may exceed their capabilities. The burden on manufacturers to get their IVDs certified will also depend on whether NBs become available toward the end of the first transition period, and whether they remain clustered in certain parts of Europe. Currently, the six designated NBs are established in only three countries — Germany, France and the Netherlands. Manufacturers in other member states will find certification especially challenging.
It remains critical for manufacturers to plan IVDR certification well in advance to account for significant delays. Manufacturers, importers and distributors will also have to account for the staggered transitional periods for different IVD classes when developing a certification strategy.
ICON’s dedicated Medical Device and Diagnostics Research team has over 30 years of experience working with medical device and IVD companies of all sizes. Contact us to learn how we can help you navigate these challenges and prepare your business for success under the new regulations.
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