The European Union’s (EU) Artificial Intelligence Act (AI Act) drew a fair amount of criticism when it was first released, but Team-NB, the association of notified bodies (NBs) for the EU, has weighed in with some less than flattering observations. The group’s position paper on the legislation said that the act would not only up-classify some artificial intelligence algorithms to a higher risk class but would also resurrect the backlog of applications because of burdensome new requirements for NBs, thus exacerbating an existing crisis of med tech availability in the EU.

“The incomplete in vitro diagnostic regulation (IVDR) poses critical ongoing risks that need urgent resolution,” said Medtech Europe, as it welcomed the coming into force of the new EU regulatory system on May 26. Five years since the publication of the regulation, and after the industry has invested “significant resources into complying with its requirement,” some key elements of the infrastructure “are still not fully operational or even in place,” according to the trade body. “It is critical that all needed infrastructure is put in place and made operational without delay,” said Serge Bernasconi, CEO of Medtech Europe.

The guidances for in vitro diagnostics (IVDs) developed by the European Union’s Medical Device Coordination Group (MDCG) are only a reflection of the In Vitro Diagnostic Regulation (IVDR), but they do provide test developers with some important details.

Regulatory agencies across the globe had their hands full in 2020 and 2021 in responding to the COVID-19 pandemic, but that is just one reason that regulatory frameworks for artificial intelligence are lagging. Several regulatory proposals have been floated, but one of these hints at a need for regulatory harmonization, a requirement that seems certain to add yet more drag to a process that is already years behind the technology.

Makers of vitro diagnostics (IVDs) are facing several significant challenges in the next few years, thanks to existing and impending revisions to a number of regulatory frameworks. There are other considerations that are adding to the headwinds, such as a poor patent protection environment in the U.S., the net effect of which is to make life unusually miserable for developers of these tests.

The shortage of European notified bodies (NBs) for in vitro diagnostics has prompted calls from industry to delay the compliance dates for the In Vitro Diagnostic Regulation (IVDR), and the European Commission has responded with a proposed fix. The Commission proposed to give IVDs that are already on the market until May 2025 or later to obtain new CE marks, but the change requires the assent of the European Parliament and the European Council before it goes into force.

The EU’s Medical Device Regulation is now in full implementation mode, but the In Vitro Diagnostic Regulation (IVDR) won’t kick in until May 2022. Oliver Bisazza, director general of Medtech Europe, said that only six notified bodies are currently certified to review IVDs under the new regulatory framework, a predicament which suggests that many these tests will never again be available to patients.

PERTH, Australia – Changes to Australia’s medical device requirements have resulted in certain devices no longer requiring TGA conformity assessment certification, including class IV in vitro diagnostics (IVDs). As of July 23, 2021, devices that contain drugs or materials of animal, microbial, recombinant or human origin no longer require mandatory TGA conformity assessment certification. Instead, sponsors of these devices will be able to provide conformity assessment documents issued by notified bodies designated by a European Union member state to support their applications on the Australian Register of Therapeutic Goods (ARTG).

The European Commission has posted the first sets of standards for the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The new publications had been long-awaited as more and more manufacturers leverage voluntary consensus standards to comply with requirements across regulatory bodies while promoting international harmonization.