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In Medical Devices

Waiting for your EU MDR Certificates? 5 Takeaways on the Intended Extension to Transitional Periods

by , , and 9 Mins Read

In brief In a recent EPSCO meeting, the European Commission (“Commission”) finally confirmed that it intends to extend the transitional period under the Medical Devices Regulation 2017/745 (MDR). In parallel, the Medical Device Coordination Group (MDCG) has published a Position Paper (2022-18) that offers a supplemental or short-term solution, allowing manufacturers to benefit from an exemption under Article 97 for a temporary period. While this means that the outlook for MDR implementation is more positive, the Commission’s approach is…

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In Medical Devices

Swiss Federal Administrative Court Confirms Alignment of Classification of Software Used for Contraception Between Switzerland and EU

by , , and 5 Mins Read

In brief In its decision of 12 September 2022 (C-1256/2020), the Swiss Federal Administrative Court (FAC) confirmed that interpretive software that uses indicators such as calendar days and body temperature to monitor fertile and infertile phases of a menstrual cycle to achieve natural conception or prevent undesired pregnancy, qualifies as a medical device. This means that such software is subject to a conformity certification procedure with a notified body. In its reasoning, the FAC primarily focused…

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In Digital Health

The UK’s MHRA Publishes Roadmap for AI and Software as a Medical Device

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In brief The UK government has recently published its roadmap for regulating AI as a medical device (AIaMD) and software as a medical device (SaMD). This will form part of the basis of the upcoming UK Medical Device Regulation reforms in 2024. In light of the operational difficulties faced by the NHS, AIaMD and SaMD are attractive solutions to alleviate pressures on the UK health system. Yet these products are complex and require a high…

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