In brief On 10 November 2022, the National Coordination Centre for Ethics Committees (“Centre”) published the updated versions of the “Contract for the performance of clinical trials on medicines,” the “Contract for the performance of independent clinical trials on medicines” and the “Contract for the performance of clinical investigations on medical devices that are not CE marked or CE marked but used outside their intended use.” Key takeaways In particular, the updates relate to: (i)…
In brief On 1 December 2022, Implementing Regulation EU 2022/2347 on the reclassification of groups of certain active medical devices without an intended medical purpose, as listed in Annex XVI to Regulation EU 2017/745, was published in the Official Journal of the EU. Key takeaways The Implementing Regulation introduces an exception to the general rule, according to which active devices that are not included in a particular risk class according to the classification rules fall…
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…
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…
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…