In brief The amendment to the Medical Device Regulation 2017/745 (MDR) and the In Vitro Medical Device Regulation 2017/746 (IVDR) has been published and enters into force immediately (20 March 2023). What does this mean for your organisation? The amendment extends transitional periods under the MDR for legacy devices (if manufacturers act now) and removes the “sell-off” date under the MDR and IVDR. We’ve set out our top four takeaways below: 1. New extended transitional…
In brief The first ever guidance on social media has been issued by the Prescription Medicines Code of Practice Authority (PMCPA) to help pharmaceutical companies apply the high standards demanded by the industry’s ABPI Code of Practice to all their online communications channels. The PMCPA Social Media Guidance 2023 has been produced in consultation with the Medicines and Healthcare Products Regulatory Agency (MHRA), the ABPI, and pharmaceutical companies. It includes advice for companies to help them use…
In brief The MHRA lifted some extra burden from the industry by extending the European Commission Decision Reliance Procedure (ECDRP) by 12 months until 31 December 2023. The ECDRP was introduced following Brexit and is available to medicines approved via the EU centralized procedure. Before 31 December 2023, in situations where a Committee for Medicinal Products for Human Use (CHMP) positive opinion has been received, applicants can continue to submit their ECDRP Marketing Authorisation Application (MAA) or…
The UK’s Department of Health and Social Care has announced that the voluntary scheme payment percentage (VPAS) for 2023 will be set at 26.5% of sales for 2023 (representing almost GBP 3.3 billion). This is a further major increase to last year’s VPAS significant rate rise to 15% (around GBP 1.8 billion, rising from GBP 0.6 billion in 2021). VPAS is an agreement between the Department of Health and Social Care (DHSC), NHS England and…
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…
In brief At the end of September, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published a long-awaited Note for Guidance to assist their member companies with their use of social media and digital channels. The guidance aims to set out the areas that companies should consider when communicating on social media and other digital channels, and builds on existing guidance, including the Principles …