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The UK Department of Health and Social Care (DHSC) has published a new policy paper “The future of healthcare: our vision for digital, data and technology in health and care” setting out the UK’s approach to using the best technology available in the National Health Service (NHS) and social care sector to provide better care and improved health outcomes. The DHSC recognises the potential of new technologies to provide ground-breaking diagnostic, treatment and preventative interventions,…
The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively. New guidance documents concerning the UDI system are also available on the European Commission website. The rolling plan The rolling plan contains a list of “essential implementing acts and actions” which must be put in place by the European Commission during…
On 4 October 2018, the European Parliament adopted its Report on the Commission Proposal for a Regulation on Health Technology Assessment (HTA). HTA is a multidisciplinary process or tool to analyse issues related to the use of a health technology. HTA is applied to assess the added value of a given health technology compared to other technologies for the same purpose. The Proposal covers new medicinal products and certain medical devices. It would provide the…
The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, introduced a new online application. The online application makes it possible to request a cGMP Declaration (Current Good Manufacturing Practice). A cGMP Declaration can be issued by the FDA to a foreign regulator, such as the competent authorities of an EU Member State. The declaration issued by the FDA is intended to confirm the current cGMP US…
On September 24, 2018 and September 28, 2018, the Department of Veterans Affairs (VA) and the Small Business Administration (SBA), respectively, released complementary final rules (VA final rule and SBA final rule) that amend the regulations governing Veteran-Owned Small Businesses (VOSBs) and Service-Disabled Veteran-Owned Small Businesses (SDVOSBs). Effective October 1, 2018, the SBA’s regulations now govern the ownership and control requirements for all VOSBs and SDVOSBs, and the VA regulations that formerly provided eligibility…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be amended in the event of a “no deal” scenario, i.e. if the UK leaves the EU on 29 March 2019 without the framework for a future EU-UK trading relationship agreed or a transition period. The MHRA reiterates in the consultation that the UK…
Deputy Secretary of Defense Patrick Shanahan announced on Monday, October 1, 2018, that the U.S. Department of Defense (“Department” or “DoD”) was withdrawing its proposal that would have made sweeping changes to the rules that govern the release of progress payments to contractors under DoD contracts. In rescinding the proposed rule, Deputy Secretary Shanahan cited to a lack of coordination within the Department that led to a premature release of the proposed amendments. Under its…
In the final batch of technical notices, the UK Government has provided guidance on what impact traders can expect on food labelling and packaging in the event that the UK exits the EU without a Withdrawal Agreement on 29 March 2019. Producing and labelling food Currently, EU rules, such as EU Regulation 1169/2011 or “FIC”, govern food labelling and minimum compositional standards (with some exceptions) for foods in the UK. As explained in a previous…
The concept of human rights due diligence is at the heart of the UN Guiding Principles on Business and Human Rights (“UNGPs“) and is finding its way into a growing body of legislation around the world: see the French Duty of Vigilance Law, the supply chain transparency provisions of the UK Modern Slavery Act (and Australian counterpart), the California Supply Chain Transparency Act, the Dodd Frank Act, the EU Conflict Minerals Regulation and most…
The UK Government has released a further batch of technical notices, providing guidance to businesses on the implications of an exit from the EU without a Withdrawal Agreement on 29 Mach 2019. Three of these notices will be of particular interest to businesses trading goods in other EU Member States: 1. Trading under the mutual recognition principle if there’s no Brexit deal. After Brexit, non-harmonised goods (goods which are regulated by national law rather…