Latest industry news and developments
Team NB has released an updated version of the Code of Conduct for Notified Bodies, introducing key changes in line with current EU regulations on medical and diagnostic devices. The new version focuses on harmonizing operations, increasing transparency in certification processes, and enhancing oversight of product safety.
In accordance with Article 50 of Regulation (EU) 2017/745 on medical devices and Article 46 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices, notified bodies establish lists of their standard fees for the conformity assessment activities that they carry out and make those lists publicly available.
The US Food and Drug Administration (FDA) updated list of of authorised AI/ML-Enabled Medical Devices. This marks a significant 37% increase from last year (692 devices). The majority of the approved devices (750 out of 950) are designated for radiology, with cardiology following at 98 devices and neurology at 34. The FDA emphasizes that the list isn't exhaustive but covers AI/ML devices across medical disciplines based on marketing authorization document summaries.
We are excited to announce that MDR Regulator has joined the AI in Health Coalition as a supporting member! Our involvement in this coalition signifies our commitment to advancing the integration of artificial intelligence in healthcare. We look forward to collaborating with other industry leaders to drive innovation and improve patient outcomes.
On July 16th, an exceptional webinar organized by Izba Polmed and our partners: MedTech Polska, AI w Zdrowiu, MDR Regulator, and Pure Clinical took place. The turnout was fantastic, and we thank all participants for their active involvement!
On 12 July 2024, regulation (EU) 2024/1689 was issued, introducing a regulatory framework for artificial intelligence (AI), the AI Act. The publication came more than three years after the European Commission published the proposed original text in April 2021. The AI Act aims to promote trustworthy AI while ensuring a high level of protection for health, safety and fundamental rights of the EU. The document defines requirements for AI systems according to the level of risk posed and imposes obligations on providers placing on the market or putting into service AI systems.
On 9 July 2024, regulation (EU) 2024/1860 was published regarding a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply of devices and transitional provisions for certain in vitro diagnostic medical devices. The new regulations are aimed at ensuring patient safety and protecting public health, as well as avoiding disruption of the medical device market. Regulation extends transition periods for in vitro diagnostic medical devices to prevent shortages and ensure continuity of health care.
The FDA, Health Canada, and the UK's MHRA have established guiding principles to enhance transparency in machine learning-enabled medical devices (MLMDs). These principles focus on clear communication about a device's use, development, performance, and decision-making logic to ensure safe and effective patient care. Human-centered design is emphasized to make information accessible and understandable for all users.
Phthalates, widely used as plasticizers in various industries, pose health risks due to their weak interaction with polymers, leading to potential human exposure. The Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) has released updated guidelines on the benefit-risk assessment (BRA) of phthalates in medical devices. These guidelines focus on phthalates that are carcinogenic, mutagenic, toxic to reproduction (CMR), or have endocrine-disrupting (ED) properties. The revisions, the first since the guidelines were published in 2019, incorporate new regulatory developments, updated methods, and enhanced evaluation frameworks based on recent scientific data and experiences.
