Europe – 40ème organisme notifié au titre du règlement (UE) 2017/745
40ème ON notifié au titre du règlement 2017/745
USA – FDA reiterates guidance plans on distributed and point-of-care manufacturing
The US Food and Drug Administration (FDA) this week reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed...
Europe – Notified body perspective: Evaluating uses for real-world data
Real-world data (RWD) can provide useful information that may be included in clinical data submissions, but the greatest value may be during the postmarket...
USA – FDA extends regulatory flexibilities for PMA, HDE modifications
The US Food and Drug Administration (FDA) has published a final guidance that extends its pandemic-era policy of allowing manufacturers to make certain modifications...
UK – MHRA to launch the AI-Airlock, a new regulatory sandbox for AI developers
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced it is taking forward its new ‘regulatory sandbox’, the AI-Airlock, that will provide a...
International – IMDRF publishes new procedures on membership, governance
The International Medical Device Regulators Forum (IMDRF) recently updated its procedures for membership and for developing and managing technical guidelines.
The 40-page Standard Operating Procedures...
Europe – Stakeholders seek short-term fixes, long-term reform for European medtech regulations
Medtech stakeholders say there needs to be a reform of the European medtech regulatory system to improve efficiency, consistency and agility.
Cracks in the current...
Europe – Experts outline current knowledge on AI and medical devices
With European legislation on how to regulate the integration of artificial intelligence (AI) into daily life on the horizon, it’s time to consider how...
International – Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly identified 10...
UK – MHRA and international partners publish five guiding principles for machine learning-enabled medical...
The MHRA, FDA and Health Canada have today published five guiding principles for the development of PCCPs for MLMD manufacturers. These guiding principles aim to support...
