Euro Roundup: Team-NB warns European AI Act will cause serious market access implications

The proposed European Artificial Intelligence Act (AIA) could have “serious implications” that prevent access to the latest technologies, according to an association of medical device notified bodies.

If enacted, AIA would require notified bodies to apply to be entrusted with the assessment of AI, much as they already do to perform conformity assessments for medical devices and in vitro diagnostics. Overlaps between the pan-industry AIA and medtech-specific regulations have been a cause for concern in some quarters since the publication of the AI proposal.

Team-NB (The European Association of Medical devices Notified Bodies) is the latest group to offer its opinion on the proposal. The association thinks AIA will be problematic if adopted in its current form for the medtech industry and the patients it serves.

“Manufacturers having AI driven [medical devices] placed already on the market, will suddenly have no [notified body] allowed to process their change requests, vigilant cases, etc., during the designation process. New manufacturers promoting the AI technology, on the other hand, will not be able to enter the market at all, depriving the European population from having access to the latest technologies,” Team-NB wrote in a 16 December position paper.

According to Team-NB, notified bodies designated under the new medtech regulations already can cover the requirements proposed in AIA. Adding AI-specific requirements will create “additional bureaucratic burden” and force notified bodies to invest resources in seeking AIA designation “rather than for building the internal competence for assessment of AI in medical devices,” according to Team-NB. The association warns AIA “will have an undesirable impact” on the already limited notified body numbers and capacity.

Team-NB Paper

EMA targets ‘gradual lifting’ of COVID business continuity measures in 2023

The European Medicines Agency (EMA) plans to gradually lift the business continuity measures it put in place to cope with its relocation to Amsterdam and the COVID-19 crisis.

EMA put some nonessential activities on hold in 2019 to ensure it could keep performing core tasks as it relocated its headquarters and adjusted to the loss of the staff who chose to stay in London. Shortly thereafter, the COVID-19 pandemic placed new pressures on the agency and drove it to keep the business continuity plan in place.

“By monitoring the evolution of the workload related to COVID-19 and based on resource availability, the agency will seek opportunities to gradually reinitiate previously suspended or reduced activities, notably implementing a phased restart of clinical data publication for centrally authorized medicines beyond the scope of COVID-19,” EMA wrote after its management board met to discuss the plan.

The management board committed to trying to lift the business continuity measures after adopting the agency’s multiannual programing document for 2023-2025 and confirming the budget for next year. EMA is set to receive an 8.6% increase in its budget, bringing the total up to €458 million (US $486 million).

One of the first big items on the agenda for 2023 is the establishment of the Clinical Trials Information System (CTIS) as the single-entry point for sponsors and regulators for the submission and assessment of all new clinical trials. On 31 January, CTIS will become mandatory after the one-year transition period ends.

“The board noted the progress towards further stabilization of the system in preparation of compulsory use. This stabilization will improve user experience,” EMA wrote. “The agency informed the board about its delivery plan to ensure no blocking technical issues in the core processes by the legal deadline and its commitment to this plan.”

EMA has created a 2023 work plan for CTIS that focuses on implementing improvements in the most impactful functional areas of the system, futureproofing and minimizing risks to the technical core with the goal of improving the user experience. Initiation of the work plan is subject to the stabilization of the system, leading the board to request weekly updates from EMA on work toward that goal.

EMA Statement

EFPIA finds ‘very high’ compliance with responsible clinical trial data sharing principles

Compliance with the joint EFPIA/PhRMA Principles for Responsible Clinical Trial Data Sharing is “very high” but falls short of 100% in certain areas, according to a new survey released by EFPIA (the European Federation of Pharmaceutical Industries and Associations).

Surveying 35 companies, the group found all the respondents are sharing study protocols and trial-level data. All but one are sharing patient-level data. All the companies are sharing factual summaries of clinical trial results, such as the data posted on EudraCT, with the patients who participate in their studies. Compliance with legal requirements was 100%.

The survey revealed areas in which industry practices have evolved beyond the principles, which date back to 2014. EFPIA found that all companies have implemented a system to receive and review research proposals and provide applicable data and protocols to help facilitate scientific and medical research. However, compliance with specific elements of that principle were below 100%.

EFPIA found that 17% of companies lack a scientific review board, 14% have not publicly posted their data sharing request review process and 54% have not made the identity of the members of their scientific review boards available publicly. The trade group said the results reflect the fact that “sponsors have implemented a multi-sponsor platform solution or other ways for sharing data.”

“This result demonstrates that the principles need updating to include alternative ways for sharing data,” EFPIA wrote.

EFPIA Notice

MHRA agrees device principles on international recognition, innovation and system capacity

The UK Medicines and Healthcare products Regulatory Agency (MHRA) CEO June Raine has agreed to the publication of aligned principles on the reform of medical device regulations.

Raine represents MHRA on the Life Sciences Council, a group that brings the regulatory agency together with representatives of the UK government and the Association of British HealthTech Industries. The council has formed an advisory group to support the medical device regulatory reform agenda and set out its initial plans.

The advisory group will publish aligned proposals on three priority areas: international recognition; routes for innovation; and system capacity. Initial proposals are scheduled for release in February and will address how concepts such as the use of e-labelling and recognizing the approvals of other trusted jurisdictions, such as the US, could work to free up regulatory resources and reduce burdens on industry.

MHRA Notice

Sanofi Pasteur secures authorization of VidPrevtyn Beta vaccine in the UK

Sanofi Pasteur has received MHRA authorization for VidPrevtyn Beta, an adjuvanted, recombinant protein COVID-19 vaccine that targets the spike protein of the SARS-CoV-2 beta variant.

MHRA authorized the vaccine for use as a booster in people aged 18 years and over who have previously received a mRNA or viral vector vaccine as a primary course. Sanofi secured the authorization on the strength of data from 800 people who received its vaccine after previously being immunized with a mRNA or viral vector vaccine. The vaccine uses an adjuvant from GSK.

The UK authorization comes weeks after the European Commission approved the vaccine. With the UK limiting its booster program to at-risk groups, and other vaccines meeting that demand, it is unclear if a significant opportunity awaits VidPrevtyn Beta.

MHRA Statement

Euro Roundup: Team-NB warns European AI Act will cause serious market access implications

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