Euro Roundup: Notified bodies highlight issue that could ‘massively hinder’ AI regulation
The European Association of Medical devices Notified Bodies (Team-NB) has warned that a shortage of organizations to review artificial intelligence devices could hinder the European Union’s AI Act.A staggered transition to the AI Act is underway, with Team-NB listing August 2026 and August 2027 as two key dates. Under the legislation, notified bodies will be involved in assessing high-risk AI systems. Member States need to set up procedures for assessing, designating, and notifying conformity assessment bodies.
Team-NB, whose members underwent a similar process for the medtech regulations, told the European Commission that it is concerned that notified body capacity constraints will cause problems. A lack of notified bodies would jeopardize enforcement, massively hinder the optimal application of the AI Act, and delay new product launches, Team-NB said.
The association’s fears are underpinned by questions about whether notified bodies will operate in a clear, stable, and predictable environment. Team-NB said the lack of such an environment could make it harder for AI developers to submit complete applications. Incomplete applications can require additional review cycles, clarifications, and coordination, put extra demands on notified bodies, and delay launches.
Team-NB is also concerned about the act’s potential to increase notified body costs. The act requires notified bodies to employ specialists, Team-NB said, and organizations will need extensive staff if qualification requirements become unnecessarily detailed. Team-NB questioned what level of detail is needed to ensure the level of safety, health, and fundamental rights protection envisioned by the act.
The concerns led Team-NB to suggest using existing frameworks for appointing notified bodies. Notified bodies are already certifying AI products and under surveillance by competent authorities. Using those existing frameworks could avoid duplicating tasks, Team-NB said. The association also wants officials to consider explicit reimbursement or compensation mechanisms to offset notified bodies’ rising costs.
Team-NB Notice
EMA seeks feedback on planned overhaul of ulcerative colitis trial guideline
The European Medicines Agency (EMA) has published a draft concept paper about plans to update its advice on the development of ulcerative colitis medicines in children.
EMA last updated the guideline in 2018, when it added information on when it is possible to extrapolate adult data to children and when sponsors need to generate separate data in the pediatric population. Yet while the guideline contains provisions for pediatric development, and the incidence of ulcerative colitis is higher in younger people, EMA said the selection of medicines available to children is limited.
The agency has identified pediatric drug development challenges that are likely to delay the availability of authorized ulcerative colitis treatments for children. EMA’s draft concept paper outlines the problems to inform a planned update of the guidance.
Enrollment in placebo-controlled trials is one challenge. EMA said once efficacy at an acceptable safety level has been established in adults the potential for children to receive placebo can deter enrollment in trials. The agency said off-label pediatric use, the availability of suitable alternative medicinal products, and ethical reasons are deterrents. EMA plans to reconsider when a placebo arm is needed.
The agency has identified efficacy endpoints as another issue. The use of endoscopic remission, both for the induction and the maintenance phases of treatment, as a co-primary endpoint requires children to undergo repeated endoscopic procedures. EMA said the burden of those procedures, including anxiety and absence from school or work, can be a barrier to enrollment.
While reconsidering the need for endoscopy, EMA will assess the value of non-invasive ways to evaluate efficacy. Ultrasound and the patient-reported outcome TUMMY-UC could be used to assess efficacy. EMA said non-invasive measures are increasingly accepted in the scientific community, but their value should be convincingly demonstrated before they are used.
The draft concept paper also covers the extrapolation of data from adult trials. While the existing text allows extrapolation, EMA is considering making its position more explicit to spare children unnecessary trials. The agency is considering using observational data to support extrapolation.
EMA is seeking feedback on its draft concept paper until 31 December. The feedback will inform changes to the pediatric sections of the existing guideline. EMA said regulatory requirements for adults are still considered generally acceptable.
Draft Paper
EDQM outlines requirements for incoming automated CEP submission process
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published the requirements for imminent changes to the Certification of Suitability (CEP) application process.
On 1 November, EDQM will introduce automation to improve its process for receiving CEP submissions. As part of the change, EDQM will require filings with electronic common technical document (eCTD) sections to be validated against the currently applicable EU region criteria. EDQM wants applicants to perform the task using an appropriate eCTD validation tool.
“It is important that these updated requirements are taken into account when preparing and submitting applications,” EDQM said. “Failure to do so will delay validation or may lead to the application being blocked on receipt.”
Applicants must correct any fail errors identified during eCTD validation before sending their submissions to EDQM. The directorate has provided advice on the validation report location, naming, and file format requirements. EDQM also updated its guide to using the Common European Submission Portal to reflect changes to CEP filings.
EDQM Notice, CESP Guide
European Commission posts implementing decision on harmonized standards
The European Commission has updated an implementing decision on harmonized standards for certain medical devices.
Officials first published harmonized standards for medical devices in 2021. The document listed five ISO standards that can be used to provide a presumption of conformity with aspects of the regulations on medical devices and in vitro diagnostics. The Commission later updated the list with more standards.
The latest update covers surgical clothing and drapes, medical face masks, and sterilizers for medical purposes. The Commission has added two sets of requirements and test methods for surgical clothing and drapes, plus one each for medical face masks and sterilizers for medical purposes. The documents cover information specific to the device classes that companies should provide to third-party verifiers.
Officials added the documents to the list after standardization committees updated the texts in light of technological and scientific progress and requirements imposed by the Medical Device Regulation.
Implementing Decision
UK MHRA picks tools for second phase of AI Airlock, backs side effect study
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has named the next set of participants in its AI Airlock program.
Having reviewed the pilot phase of the program, the UK regulator has granted developers of seven technologies the chance to test their products in the Airlock until March. The AI Airlock team will work with the developers to address simulated testing scenarios, assess a technology in a controlled data environment, or use a product in the intended environment.
MHRA provided the update days before sharing details of its work to use AI to predict side effects. The agency has received funding to use AI to find patterns in anonymized health data. MHRA is looking for side effects associated with the use of multiple medicines in patients with cardiovascular disease. The goal is to prevent side effects, which are estimated to cause one in six hospital admissions in England.
Press Release, More
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