Experts: Lack of EU reference labs due to regulatory uncertainties, COVID workload

Regulatory NewsRegulatory News
| 15 August 2022 | By Ferdous Al-Faruque 

The European Commission is having a difficult time getting member states to offer up European Union reference laboratories (EURLs) to review high-risk in vitro diagnostics (IVDs) under the In Vitro Diagnostic Medical Devices Regulation (IVDR). Industry experts say lack of clear regulations and the COVID-19 pandemic may be behind the dearth of candidates.
 
The EC sent a call out to member states in the European Economic Area (EEA) in July seeking EURLs to help review high-risk IVDs. More specifically the Commission has asked for EURLs to cover eight categories of class D IVDs, including those for hepatitis and retroviruses, herpesviruses, bacterial agents, arboviruses, respiratory viruses that cause life-threatening diseases, hemorrhagic fever and other biosafety level 4 viruses, parasites and blood grouping tests.
 
The Commission has asked candidate laboratories to apply to their EEA member states, and it has recommended a 5 January 2023 deadline for such applications.
 
Alex Laan, a principal IVD regulatory consultant at NAMSA, told Regulatory Focus that lack of regulatory clarity has likely prevented labs from stepping up to the plate.
 
“Although the role of the EURL seems pretty clear in the IVDR, the EU regulation still requires the European Commission and Competent Authorities to lay the foundation for relevant stakeholders (laboratories) to take on these responsibilities; this should for instance be done by publication of delegated and implementing acts that will steer this designation process,” he said. “And, until recently, there were no common specifications published that enable medical laboratories to carry out these testing activities. Since this had not been done in an earlier stage, the request for member states to come with candidates for EURLs have also been pushed out.”
 
Gert Bos, executive director of the Qserve Group and president of the Regulatory Affairs Professionals Society’s (RAPS) board of directors, said that getting reference labs to take on the responsibility has been an issue even under the previous regulatory regime.
 
“The typical labs currently doing IVD work, or supporting some investigation, might have been interested to become notified bod[ies] back in the day,” he told Regulatory Focus.
 
But he notes that many of them are busy serving their own countries by helping regulators review drugs, biologics and companion diagnostics.
 
“Also as the pharma legislation is undergoing a serious revision including shifts in responsibilities and involved players, there are quite some uncertainties ahead [for these labs],” Bos added.
 
On top of that, Laan said that EU member states may be hesitant to take on more responsibilities when submitting EURLs to the EC, as many of those labs are likely overburdened due to the pandemic and are now also testing for monkeypox. He also said the testing activities required within the scope of the conformity assessments require a lot of new investment in equipment, personnel and time that many of the labs may not be able to spare right now or don’t have the incentive to invest in.
 
If no one respond to the call to offer up EURLs, Bos said there will be debates at the EU level to try to engage stakeholders to take on the responsibility.
 
“A second call, or an elongation might find a solution,” he added. “If that does not help, EU legislators will need to become creative on the matter.”
 
Laan said that if member states do not offer EURLs to the EC, the commission may be forced to appoint testing labs to the governments in the EEA member states but that would send a bad message to stakeholders in the EU.
 
“If no EU member state is able to propose a candidate lab, the only two options I see is to resort to a commercial laboratory in the EU that is able to take this on; if there is interest. Or, ask another reference lab in other parts of the world (for instance in the US) that already carries out this kind of activity,” such as the US Centers for Disease Control and Prevention (CDC), he said.
 
However, Laan said it is unlikely the EC would want to hand over some responsibilities of EU notified bodies responsible for batch verification testing under the IVDR to commercial labs and in effect take on responsibilities of the EU government.
 
“When drafting the IVDR, the EC had reasons to relieve these responsibilities from the EU Notified Body and place this under the responsibility of the EU Competent Authorities as part of the market oversight; but this is more politics, if you ask me,” he said.
 
Laan said the second scenario is even less likely since the responsibility for reviewing the products would stay with the governments, but the lab would be based outside the EEA.
 
“I am not a lawyer, but I think this would go against the basic principles of EU oversight,” he said. “Ultimately, a third feasible option would be that the EC finds funding to set up a centralized EU reference lab that is able to conduct these batch release tests. There are examples of institutes that are centralized (think of [the European Medicines Agency] EMA, for centralized approval of medicinal products).”
 
Bos said the lack of reference labs has been confusing and led to uncertainties for stakeholders, especially for IVD developers.
 
Fortunately, Laan said the lack of EURLs hasn’t been a problem yet as notified bodies can still accept class D IVD applications and issue corresponding certificates during the transition period as long as no EURL has been designated for a specific device, category or group of devices. He also notes that those certificates will remain valid until an expiry date is established by notified bodies based on the IVDR.
 
Laan said for sample or batch testing, the notified body and manufacturer should follow the EURL-related provisions of the IVDR from the time that the EURL becomes operational. As for performance verification, the notified body should follow the EURL-related provisions of the IVDR at the time of the re-certification.
 
“Since the transitional period has shifted from 26 May 2024 to 26 May 2025, there is still some time, and the lack of available EURLs is not affecting the market now,” said Laan.
 
Laan questioned what would happen if EURLs disapprove of test results of IVD batches that have been released by the notified bodies during the interim period.
 
“The key question is if conformity assessments will be stuck in case they need a reference lab involvement, or if in case of their absence the notified bodies can ignore that part and move ahead to certification,” said Bos “No answers here at this stage.”

 

© 2022 Regulatory Affairs Professionals Society.

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