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Latest industry news and developments

May 27, 2024

Changes in the guidance on MDR appropriate surveillance – MDCG 2022-4 Rev. 2

According to Article 120(3e) of the MDR, the notified body that issued your MDD or AIMDD certificate is still responsible for monitoring your devices to make sure they meet the necessary requirements. This means that their surveillance activities will continue as they did before under the previous Directives. The revised guidance regarding the transitional provisions […]

May 10, 2024

MHRA launches AI Airlock to address challenges for medical devices that use Artificial Intelligence

Last month, the MHRA outlined its strategy for regulating AI in response to a government white paper. This new pilot project aims to address challenges in regulating standalone AI medical devices (AIaMD) by initially supporting 4-6 projects. The goal is to test regulatory issues for these devices when used in the NHS. The regulatory sandbox […]

April 25, 2024

Information from Swiss Medtech on placing on the market

During the shift from MDD to MDR, MDD-compliant devices can only be introduced into the Swiss market until a specified date. Consequently, there's a potential scenario where certain products currently stocked in Swiss warehouses may become unsellable on May 27, 2024. To mitigate this risk, Swiss Medtech has developed a guidance document.

European Commission building
April 11, 2024

European Commission’s Dashboard about reprocessing of medical devices

The concept of "reprocessing" in the context of medical devices refers to the process of safely preparing a used device for reuse through cleaning, disinfection, sterilization, and related procedures. The European Commission's Directorate-General for Health and Food Safety commissioned a study to evaluate the implementation of Article 17 of the MDR on the EU market. As part of the study, a dashboard has been developed to provide an overview of mapping activities related to the reprocessing and reuse of single-use devices in the EU.

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