Directorate-General for Health and Food Safety

E-cigarette use has risen sharply among young never-smokers, largely driven by the availability of several thousand appealing flavours. This narrative review synthesises evidence on the health effects of vaping, flavour toxicology and attractiveness, designs and outcomes of flavour bans, and complementary measures. Peer-reviewed publications and institutional reports (up to January 2026) were retrieved from PubMed, Web of Science, Google Scholar, and reference lists of included articles. Evidence from about 200 references was synthesised by a multidisciplinary working group. Although flavouring substances are generally considered safe for ingestion, their inhalation toxicity remains uncertain. In vitro and in vivo studies have reported oxidative stress, inflammation, cytotoxicity, impaired ciliary function, transcriptomic changes, genotoxicity, and DNA damage. These findings-along with the strong youth appeal of fruit/sweet flavours, the inconclusive effects of flavours on smoking cessation, and persisting uncertainties-support banning non-tobacco e-cigarette flavours under the precautionary principle. Flavour bans can reduce e-cigarette use and initiation, especially among young adults, although partial substitution towards combustible cigarettes has been reported in some U.S. states. Policy success requires effective enforcement, prevention of industry circumvention, curbing cross-border sales, and closing regulatory loopholes-ideally at the international level (e.g., EU-wide). E-cigarette flavours may increase vaping toxicity and strongly appeal to youth, justifying flavour bans to prioritise youth protection. To maximise effectiveness, accompanying measures and sustained investment in tobacco prevention, youth education, and accessible evidence-based smoking cessation support are essential.

The European Union (EU) Medical Device Regulation increased regulatory scrutiny to improve the safety and performance of new medical devices. An equally important goal is providing timely access to innovative devices to benefit patient care. The European Society of Cardiology strongly advocates for the evolution of the Medical Device Regulation system to facilitate priority access for innovative devices for unmet needs and orphan cardiovascular (CV) medical devices in EU countries. Although device approval is currently executed by Notified Bodies in the EU, it will be advantageous in the mid-term to consider a single EU regulatory agency for devices. In the short term, steps can be taken to transform the current system into a more efficient, predictable, cost-effective, and user-friendly service. Key strategies include the following: enhancing predictability of the approval process through use of early scientific advice from regulators; establishing unique regulatory pathways for CV orphan, paediatric, and innovative devices; promoting more efficient (re)certification of essential legacy CV devices; improving transparency of sponsor interactions with Notified Bodies; expanding the roles of the Expert Panels to assist in the approval of CV devices; promoting global regulatory harmonization, considering streamlined authorization of CV medical technologies across selected jurisdictions; developing an efficient system to monitor device safety; and ensuring funding for data collection platforms. Some strategies that could help include considering a pilot programme for joint approval processes of selected devices in partnership with other regions (i.e. US Food and Drug Administration); developing priority pathways for accelerated access to innovative or orphan devices; and increasing recognition of the importance of early feasibility studies in the EU.

ABSTRACT Introduction Inappropriate antibiotic use is a major cause of antibiotic resistance. Therefore, optimizing antibiotic usage is essential. In Belgium, optimization of antimicrobials for the fight against multidrug resistant organisms (MDROs) is followed up by national surveillance by public health authorities. To improve appropriate antimicrobial use in hospitals, an effective national Antimicrobial Stewardship (AMS) program should include indicators for measuring both the quantity and quality of antibiotic use. Objectives The aim of this study was to develop a set of process quality indicators (QIs) to evaluate and improve AMS in hospitals. Methods A RAND-modified Delphi procedure was used. The procedure consisted of a structured narrative literature review to select the QIs, followed by two online questionnaires and an intermediate multidisciplinary panel discussion with experts in infectious diseases from general and teaching hospitals in Belgium. Results A total of 38 QIs were selected after the RAND-modified Delphi procedure, from which 11 QIs were selected unanimously. These QIs address compliancy of antibiotic therapy and prophylaxis with local guidelines, documentation of the rationale for antibiotic treatment in the medical record, the availability of AMS Programs and Outpatient Parenteral Antibiotic Therapy, resistance patterns and antimicrobial prescribing during focused ward rounds. Conclusion Our study selected 38 relevant process QIs, from which 11 were unanimously selected. The QIs can contribute to the improvement of quality of antibiotic use by stimulating hospitals to present better outcomes and by providing a focus on how to intervene and to improve prescribing of antimicrobials.

Several high-risk medical devices for children have become unavailable in the European Union (EU), since requirements and costs for device certification increased markedly due to the EU Medical Device Regulation. The EU-funded CORE-MD project held a workshop in January 2023 with experts from various child health specialties, representatives of European paediatric associations, a regulatory authority and the European Commission Directorate General Health and Food Safety. A virtual follow-up meeting took place in March 2023. We developed recommendations for investigation of high-risk medical devices for children building on participants' expertise and results of a scoping review of clinical trials on high-risk medical devices in children. Approaches for evaluating and certifying high-risk medical devices for market introduction are proposed.

Myasthenia gravis (MG) is a neuromuscular disease characterized by abnormal skeletal muscle fatiguability. The MG Activities of Daily Living (MG-ADL) scale assesses eight symptoms and is often used as primary endpoint in MG clinical trials where it is completed by neurologists. However, in observational studies, patients frequently complete the MG-ADL scale independently of their neurologist. In this study we aimed to assess the concordance between self- and physician-reported MG-ADL scores. An international observational study was conducted among adult patients with MG scheduled for a routine visit or who entered the hospital via emergency services. Consenting patients and physicians completed the MG-ADL. Concordance between assessments was calculated using Gwet's agreement coefficient (Gwet's AC) for the MG-ADL individual items and the intraclass correlation coefficient (ICC) for the MG-ADL total score. Data were collected from 137 patients (63% female; mean age, 57.7 years). Physicians assessed the patient's symptoms as slightly more severe (8.1 vs 7.5 MG-ADL total score, respectively), corresponding to a difference of 0.6 on a range from 0 to 24. The ICC for the MG-ADL total score between the patient and the physician assessment was 0.94 (95% confidence interval, 0.89 to 0.95), showing excellent concordance. Gwet's AC showed substantial to almost perfect agreement for all items, except eyelid droop, for which the agreement was moderate. Our results demonstrate that patients and neurologists have a concordant assessment of the patient's MG symptoms when using the MG-ADL scale. This evidence supports patient self-administration of the MG-ADL in clinical practice and research.