What are Europe’s new in vitro diagnostic (IVD) regulations?

A: The IVD Medical Device Regulation (IVDR) European Union (EU) 2017/746 was published on May 5, 2017, starting a 5-year transition period until its implementation. This new regulation is significantly more extensive and far ranging than the current EU IVD Directive, and now that it’s 2 years away from kicking in, IVD companies are scrambling to meet the product requirements of the new standard. Meanwhile, however, the clinical laboratory community has barely noticed this impending change.

What do these new regulations have to do with clinical laboratories?

If they are even aware of the impending regulations, most clinical laboratories think that this is an IVD-company issue that won’t affect them. However, the IVDR actually will have a significant impact on clinical laboratories, too. If a commercial clinical laboratory tests specimens from European citizens with laboratory-developed tests (LDT), these LDTs are likely to be considered “distance sales” under the new regulations, meaning that the tests will require CE IVD marking—regardless of whether the lab is or isn’t located in the EU.

Aren’t there exemptions for LDTs under the IVDR?

Yes, the IVDR includes an in-house exemption that allows healthcare institutions to manufacture, modify, and use LDTs on a nonindustrial scale to meet the specific needs of target patient groups if an equivalent device available on the market cannot already meet these needs at the appropriate level of performance. However, this exemption will only apply to a small subset of LDTs and associated labs that are part of healthcare institutions established in the EU. Most commercial laboratories will therefore be required to CE mark their LDTs. And even for the subset of labs that meet the in-house exemption, the IVDR will require them to meet several new standards, including compliance with the IVDR’s Annex 1 “General Safety and Performance Requirements” and quality management system framework.

Could the COVID-19 pandemic delay the implementation of these new regulations?

The European Union Medical Device Regulation was published on the same date as the IVDR with a planned 3-year transition through May 26, 2020, and it has been delayed by 1 year due to the COVID-19 pandemic. However, as of this writing, the IVDR’s date of application remains May 26, 2022, which is the end of the current 5-year transition period, and no delay of this effective date has been proposed. Furthermore, the pandemic has increased the public’s awareness of IVD testing and laboratories, which may reduce the likelihood of the IVDR’s application date being delayed at a later point in time.

What should clinical laboratories do to prepare?

Regardless of their location, all clinical laboratories that test specimens from European citizens using LDTs should become familiar with the IVDR and carefully review its definitions and in-house exemption. As most clinical laboratories will not meet the in-house exemption, the next step is for labs to classify their LDTs according to Annex VIII of the regulations. All labs should perform a gap analysis of their existing LDTs’ clinical evidence, particularly against Annex 1 “General Safety and Performance Requirements,” and they should also conduct a thorough assessment of their quality management system against the IVDR requirements to identify gaps and areas in need of improvement. Based on these analyses, labs should then develop and begin executing a plan to meet the IVDR requirements. Time is short and it is imperative that laboratories not delay action.

Ms. Kennel will discuss this topic during two roundtable talks (session numbers 43112 and 53212) at the 2020 AACC Annual Scientific Meeting on December 15 at McCormick Place, Chicago.

Natalie J. Kennel, RAC, FRAPS, ASQ CQE, CQMgr, is the founder and president of NJK & Associates, which helps companies with U.S. and international regulatory submissions and quality system implementations and improvements. +Email: nkennel@njkconsulting.com