Regulatory news

| August 15, 2022 | By Ferdous Al-Faruque

The European Commission is struggling to convince Member States to offer European Union Reference Laboratories (EUR) to examine high-risk in vitro diagnostics (IVDs) under the Regulation on in vitro diagnostic medical devices (IVDR). Industry experts say the lack of clear regulations and the COVID-19 pandemic could be to blame for the shortage of applicants.

The EC sent out a call to member states of the European Economic Area (EEA) in July asking EURLs to help them review high-risk IVDs. Specifically, the Commission requested that the EULs cover eight categories of Class D IVDs, including those of hepatitis and retroviruses, herpes viruses, bacterial agents, arboviruses, respiratory viruses that cause life-threatening diseases, hemorrhagic fever and other biosafety level 4 viruses, parasites and blood group testing.

The Commission asked candidate laboratories to apply to their EEA Member States and recommended 5 January 2023 as the deadline for such applications.

Alex Laan, Senior IVD Regulatory Consultant at NAMSA, said Regulatory guidance this lack of regulatory clarity probably prevented laboratories from intervening.

“Although the role of the EURL seems quite clear in the IVDR, the EU regulation still requires the European Commission and the competent authorities to lay the groundwork for the relevant stakeholders (laboratories) to assume these responsibilities; this should for example be done through the publication of delegated and implementing acts that will guide this designation process,” he said. “And, until recently, there were no published common specifications for medical laboratories to carry out these testing activities. As this had not been done at an earlier stage, the request for Member States to presenting candidates for the EURLs was also postponed.

Gert Bos, chief executive of Qserve Group and chairman of the board of the Regulatory Affairs Professionals Society (RAPS), said getting reference labs to take responsibility was a problem even under the previous regulatory regime.

“Typical labs currently doing IVD work, or supporting an investigation, might have been interested in becoming notified.[ies] at the time,” he said. Regulatory guidance.

But he notes that many of them are busy serving their own countries by helping regulators review drugs, biologics and companion diagnostics.

“Furthermore, while the pharmaceutical legislation is undergoing a serious review, including changes in responsibilities and actors involved, there are quite a few uncertainties ahead. [for these labs]“Bos added.

On top of that, Laan said EU member states might be hesitant to take on more responsibility when submitting EURLs to the EC, as many of those labs are likely overstretched due to the pandemic and are now also testing. monkeypox. He also stated that the testing activities required in compliance assessments require a lot of new investment in equipment, personnel and time that many laboratories may not be able to spare at this time or have not. no incentive to invest.

If no one answers the call to come up with EURLs, Bos said there will be debates at EU level to try to get stakeholders to take responsibility.

“A second call, or an extension could find a solution,” he added. “If that doesn’t help, EU lawmakers will have to get creative on the matter.”

Laan said that if member states did not offer EURLs to the EC, the commission might be forced to appoint test labs to EEA member state governments, but that would send the wrong message to stakeholders in the EU.

“If no EU member state is able to come up with a candidate lab, the only two options I see are to use a commercial lab in the EU that is able to do it; if there is interest. Or ask another reference lab in other parts of the world (e.g. USA) that is already doing this type of activity,” such as the US Centers for Disease Control and Prevention (CDC), has he declared.

However, Laan said the EC is unlikely to want to shift some of the responsibilities of EU Notified Bodies responsible for batch verification testing under the IVDR to commercial labs and in effect take on the responsibilities of the EU government.

“When drafting the IVDR, the EC had reason to offload these responsibilities from the EU Notified Body and place them under the responsibility of the EU Competent Authorities in the context of market surveillance. but it’s more politics, if you ask me,” he said.

Laan said the second scenario is even less likely since the responsibility for product review would lie with governments, but the lab would be based outside the EEA.

“I’m not a lawyer, but I think that would go against the basic principles of EU surveillance,” he said. “Ultimately, a possible third option would be for the EC to find funding to set up a centralized EU reference laboratory capable of conducting these batch release tests. There are examples of institutes that are centralized (think [the European Medicines Agency] EMA, for centralized drug approval).

Bos said the lack of reference labs has been confusing and led to uncertainty for stakeholders, especially IVD developers.

Fortunately, Laan said the lack of EURLs has not yet been an issue, as Notified Bodies can still accept Class D IVD applications and issue corresponding certificates during the transition period as long as no EURLs are available. has been designated for a specific device, category or group of devices. It also notes that these certificates will remain valid until an expiry date is established by Notified Bodies based on the IVDR.

Laan said that for sample or batch testing, the Notified Body and the manufacturer must follow the EURL provisions of the IVDR from the time the EURL becomes operational. With regard to performance verification, the notified body must follow the EURL provisions of the IVDR at the time of recertification.

“Since the transition period has moved from May 26, 2024 to May 26, 2025, there is still time, and the lack of available EURLs is not affecting the market at this time,” Laan said.

Laan wondered what would happen if the EURLs disapproved of the IVD batch test results that were released by Notified Bodies during the interim period.

“The key question is whether conformity assessments will be blocked in case they require the intervention of a reference laboratory, or if, in the absence of this, notified bodies can skip this part and proceed to certification “Bos said. “No response here at this stage.”

© 2022 Society of Regulatory Affairs Professionals.

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