EC Announces New Plan to Roll Out In Vitro Diagnostic Regulation

If your laboratory company does business in Europe, it needs to be tuned in to the dramatic regulatory changes that are slated to go into effect in 2022. The key date is May 26 when the European Union’s (EU) ambitious new In Vitro Diagnostic Regulation (IVDR) is scheduled to go into effect. However, like just about everything else in public life, the COVID-19 pandemic has wreaked havoc on the implementation plan. Despite the snags, snafus delays and vehement protests from the laboratory industry, the European Commission’s (EC) Medical Device Coordination Group (MDCG) has stubbornly clung to the May 26, 2022 deadline. That is, until now. On Oct. 12, the Commission finally yielded to the inevitable when it announced that it would rollout the IVDR progressively, rather than all at once on May 26. Here is a quick briefing of the IVDR and the new rollout plan.

EC Regulation of In Vitro Diagnostics

The EC and the European Parliament adopted the ((EU) 2017/746) legislative framework for regulation of in vitro medical devices, such as HIV, pregnancy and SARS-CoV-2 tests back in April 2017. That new framework is made up of two parts:

• The new medical devices regulation (MDR); and
• The IVDR.

Under the original plan, the MDR was slated to go into effect for two years, starting in May 2020 and be replaced by the IVDR two years later in May 2022. However, disruption from the global COVID-19 pandemic made it impossible to follow that schedule and the Commission postponed implementation of the MDR; but it stuck with the May 2022 implementation date and compliance deadline for the IVDR.

Impact on Laboratories and Device Companies

Outside the EC policy planning chambers, the consensus is and has been that these implementation dates are totally unrealistic. The IVD industry has been complaining about the lack of time to prepare for compliance with the IVDR. Laboratories, authorized representatives and other stakeholders must carry out major operational tasks such as revising documentation about their products, recruiting new staff and updating internal procedures, to make the transition. Achieving all of this in normal times would have been difficult enough; making the transition during the COVID-19 crisis has made the challenge even greater.

The IVD industry has been sounding the alarm about preparations for incoming regulation for over a year. One of the biggest concerns is the limited number and capacity of what are called Notified Bodies (NBs) that are responsible for certifying all of the diagnostics that need to be assessed for the first time before the IVDR can go into effect. Under the current EC Directive (98/79/EC), only about 8 percent of all in vitro diagnostics on the market are subject to NB control. The IVDR will bring around 80 percent of in vitro diagnostic medical devices under the control of NBs, the vast majority of them for the first time.

With the deadline less than a year away, only six entities have been able to achieve certification. Even the EC has acknowledged that the lack of certification of NBs so close to the implementation date represents a “grave crisis.”

The New IVDR Rollout Plan

After doubling down on May 26, 2022, the EC has finally accepted the reality of the situation and agreed to roll out the IVDR progressively. “The unprecedented challenges of the COVID-19 pandemic have diverted resources from Member States, health institutions and economic operators towards addressing the crisis, thereby hampering the capacity to comply on time with the changes introduced,” according to the EC’s October 12 announcement.

“With more time to prepare for the application of the EU new rules, we will ensure there is a continuous supply of essential in vitro diagnostic medical devices on the market, while not compromising on safety,” noted Stella Kyriakides, Commissioner for Health and Food Safety.

The proposal changes only the IVDR transitional provisions, rather than the substantive rules, with different transition periods for different type of devices, depending on the risks involved. Thus:

• Higher risk devices, such as HIV or hepatitis tests (class D) and certain influenza tests (class C), have a transition period until May 2025 and 2026;
• Lower risk devices, such as class B and A sterile devices, have a transition period until May 2027.

The Commission also proposes a deferred application of the requirements for so-called “in-house” devices, i.e., those manufactured and used within the same health institution. The new rules include requirements for justification for the use of these devices, as well as rules to ensure their safety and performance.

Takeaway: May 2022 Deadline Still Applies to CE Devices

The new proposal will now go to the European Parliament and Council, where it is expected to be adopted. Significantly, the plan proposes no change for CE-marked devices that do not require notified body involvement under the IVDR, nor for devices that are “new”, i.e., devices that have neither a notified body certificate nor a declaration of conformity under the current Directive. Thus, the IVDR for those types of devices will still take effect as planned on May 26, 2022.