In the fall of 2020, the European Commission issued a proposal to modify the implementation timeline for the new In Vitro Diagnostic Medical Devices Regulation (IVDR). Now, as of 15 December 2021, the European Parliament and the European Council have adopted this proposal, making the suggested progressive IVDR rollout timeline official.
The need for change
IVDR was introduced in 2017, and is intended to take full effect in May of 2022. It is a set of standardised requirements for in vitro diagnostic medical devices (IVDs), which gives notified bodies (NBs), also known as conformity assessment bodies, a larger role in regulation. This establishes the NBs as independent monitors of device compliance and safety before the product goes to market.
However, the number of NBs capable of conducting the required assessments is extremely limited. With 92 percent of IVDs requiring NB certification under IVDR, compared to 8 percent under previous regulations, there is a larger number of assessment submissions than the existing NBs can accommodate prior to previously established deadlines. Unaddressed, this bottleneck represents the potential of serious delays and shortages in the availability of necessary medical devices such as HIV tests, pregnancy tests, or SARS-CoV-2 tests.
New rollout timelines
IVDs that have already received CE (Conformitè Europëenne) marks under the current regulations are being given an extended transition period to undergo NB conformity assessment under the new IVDR. The original deadline for these devices was May 2024. Now, manufacturers will have more time to reach IVDR compliance, depending on the risk class of the IVD. Under the newly adopted proposal:
- Class D devices have until May 2025
- Class C devices have until May 2026
- Class B devices, and class A devices in sterile condition, have until May 2027
Laboratory-developed tests, or in-house devices, which are manufactured by the institutions that intend to use them, are also impacted by the recent modifications to IVDR. Some requirements will be delayed until 2024, representing a two-year extension. However, if an institution can prove that there is no other comparable test on the market, the deadline will be extended even further, to 2028.
As mentioned earlier, IVDR is expected to go into effect this year as planned. The requirements under this regulation have not changed, and the implementation date remains the same for all IVDs not included above. Any new devices — that is, those that do not have a current declaration of conformity or NB certificate — or devices that have undergone significant change, will need to be in compliance with IVDR requirements to go to market after May 2022.
While the progressive rollout of IVDR will alleviate some of the immediate concerns for NB capacity, NBs will still be facing a high volume of IVDs that need to undergo conformity assessment. It has yet to be seen whether these measures, alone, will be enough to allow IVDs to achieve compliance before deadlines cause significant shortages.
ICON’s Medical Device and Diagnostics Research team has over 30 years of clinical development & commercialisation service experience with medical device and IVD companies. Contact us to learn how we can help you navigate the challenges of the new regulations and prepare your business for success.
For more information: https://www.europarl.europa.eu/doceo/document/TA-9-2021-0498_EN.html