Regulatory Affairs Newsletter – Page 182

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MHRA publishes new software guidance for intended purpose

MHRA has published a new guidance page for developing an intended purpose in the context of Software as a Medical Device (SaMD). We encourage all members who make software products as a medical device should review this guidance for the UK market.

adminMarch 24, 2023

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Draft statutory instrument for the Windsor Framework published

The draft statutory instrument on the Windsor Framework has been published. This will now go through a vote in the House of Commons, but is likely to be implemented into UK law. Secondary legislation will then be developed in order to action the contents of the Framework. BIVDA have requested confirmation from MHRA and DHSC on how this Framework will…

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Innovate UK (UKRI) launches new funding competition

These programmes will focus on the future economy as described in our plan for action. The Future Economy investor partnership programme brings together: Innovate UK’s expertise in identifying innovation and using grant funding to change the risk profile of businesses investor partners’ aligned funding and expertise in identifying opportunities and teams that can best use extra investment finance More information…

adminMarch 24, 2023

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MHRA request to engage earlier for safety issues

MHRA have requested that we remind members to engage with MHRA as soon as possible on matters relating to safety. Where you think you may need to utilise the exceptional use authorisation route, or are unsure on vigilance obligations, we encourage you to contact MHRA directly for support. The EUA route can be used for any medical device or IVD…

adminMarch 17, 2023

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Public consultation on proposed Ecodesign for Sustainable Products Regulation (ESPR)

There is an ongoing public consultation on priorities under the Ecodesign for Sustainable Products Regulations (ESPR). This consultation is open until 12 May. It is possible that this could affect certain medical devices such as adult incontinence products or substances used in production of medical devices and IVDs. Members are encouraged to review this consultation and provide feedback directly by…

adminMarch 17, 2023

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DEFRA weekly update (WC 6 Mar)

Please note this is an extract of the original bulletin. The use of lead and cadmium in ion selective electrodes Page summary: Seeking your views on an application to exempt the use of lead and cadmium in ion selective electrodes from the RoHS Regulations. Change made: We added the government’s response to the consultation. Businesses approved to export to the…

adminMarch 17, 2023

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BEIS weekly update (WC 6 Mar)

Please note this is an extract of the original bulletin. Horizon Europe guarantee: updates for the UK research and development sector Page summary: The latest information on the guarantee to provide funding for successful UK applicants to Horizon Europe. Change made: Added link to Horizon Europe Guarantee press release announcing the latest extension which will support eligible, successful applicants, covering…

adminMarch 17, 2023

APHA weekly update (WC 6 Mar)

Please note this is an extract of the original bulletin. Imports, exports and EU trade of animals and animal products: topical issues Page summary: Current issues relating to imports and exports of animals and animal products. Change made: Imports of poultry, ratite and wild game bird meat into Great Britain from Argentina that were slaughtered on or after 28 February…

adminMarch 17, 2023

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MHRA weekly update (WC 6 Mar)

Please note this is an extract of the original bulletin. Advisory Group Reform Proposals Page summary: Update to the Life Sciences Council Joint Statement on Medical Devices Regulatory Reform. Change made: First published. MHRA fees Page summary: Fees payable to the MHRA for 2022 to 2023 Change made: Added link to application form to ‘apply for Small and Medium Company…

adminMarch 17, 2023

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DHSC weekly update (WC 6 Mar)

Please note this is an extract of the original bulletin. Government to consider radical new approach to prevent life-threatening cardiovascular disease Page summary: Professor John Deanfield, CBE announced as the first ever Government Champion for Personalised Prevention Change made: First published. Minister meets leading researchers in women’s health and calls for more women working in STEM Page summary: Today (Monday…

adminMarch 17, 2023