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New EU Regulations Bring Key Changes to the IVD Industry
After the European Union (EU) put its new Medical Device Regulations (MDR) in place in May 2021, the healthcare industry had a year in which to prepare for the implementation of the new In-Vitro Diagnostic Regulation (IVDR). This regulation came into force on May 26, 2022, affecting all new In-Vitro Diagnostic Devices (IVDs). Certain low-risk IVDs already on the market are also subject to revised requirements. The new European IVD regulations are expected to impact the industry in several ways, including:
Here’s how these new EU regulations are bringing about key changes in the IVD industry, and how medical device manufacturers and developers should approach achieving compliance.
The original IVD Directive (IVDD) came into force in the late 1990s, geared towards the devices available at that time. Since then, advancements in the IVD industry have resulted in innovative new technologies, including devices for cancer and genetic testing, companion diagnostics, and predictive testing among others. Meanwhile, the medical device industry was plagued by lawsuits, such as those regarding hip and breast implant problems. This scenario resulted in a drive to create legislation that guarantees the safety and effectiveness of devices. The IVDD has now been upgraded to Regulation status, which is a significant change in itself.
The EU MDR’s new IVD definition extends to predictive tests for medical conditions and diseases, companion diagnostics, specimen receptacles, and software. As with other devices under the MDR, the definition also includes the intended use of the device to identify the patient’s physical state, predispositions, congenital conditions, risk levels, and potential treatment response.
Creating Classification and Conformity
In the past, most IVDs could be self-certified under the IVDD and did not require assessment by a notified body to obtain a CE mark. The new IVDR groups devices into four rules-based classes, depending on their risks for both individual patients and public health. The classes include:
IVDs headed to market are now subject to conformity assessment and certification by a notified body designated for these devices. This is a big departure from the former system of self-declaring IVDs. Under the new regulations, only non-sterile Class A devices can now be self-declared, and all others must be assessed via a specific pathway.
As of May 2022, only seven designated notified bodies existed, located in Slovakia, France, Germany, and the Netherlands. The critical shortage of notified bodies threatens to make the approval process lengthy and challenging for manufacturers, although the EU has tabled a proposal to extend transition periods to address the delays.
The new regulations also stipulate updated performance evaluation and clinical data requirements that are far more detailed than those previously used. Performance evaluation criteria are clearly defined, and data collection must continue throughout the device’s lifetime. Requirements also now exist for using clinical IVD data and conducting clinical performance studies. For example, under the former legislation, healthcare institutions could develop in-house IVDs for rare conditions with no commercially available alternative. However, the new regulations now limit the manufacture of such ‘in-house’ IVDs.
Another way the new IVDR has altered the regulatory environment is the change to post-market surveillance. Manufacturers must appoint at least one Person Responsible for Regulatory Compliance (PRRC). Clinical evidence must be linked to risk management to ensure strict control at all stages, and traceability must exist at all points along the supply chain. Documentation is more rigorous, with new requirements that include:
Under the IVDR, manufacturers and their authorized EU representatives must also prove they have sufficient financial coverage for potential liability claims.
The new EU IVDR aims to protect patients and public health by regulating the quality, safety, and reliability of IVDs across all EU member states, Iceland, Liechtenstein, Norway, and Switzerland. In principle, the regulations have much to offer patients and providers. Still, it remains to be seen whether the legislation can live up to its promises. Success depends partly on how challenges like extended transition periods and the lack of notified bodies will affect the timely implementation of the new rules.
LSI Europe ‘22 Emerging Medtech Summit will be hosting a panel session to cover the changes of EU MDR in greater detail. Be sure to register at: https://lsi-medtech.com/LSIEurope22
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