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UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 12 Feb)

Please note this is an extract of the original bulletin. UK signs landmark economic partnership with Nigeria Page summary: Business and Trade Secretary visits Nigeria to sign a landmark UK-Nigeria economic partnership. Change made: First published. Webinars for using the UKCA marking and placing goods on the market in Great Britain and Northern Ireland Page summary: A list of upcoming…
Tehelj
February 21, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 12 Feb)

Please note this is an extract of the original bulletin. UK and EU science chiefs urge British researchers and businesses work together with European colleagues through Horizon, and apply for grants to boost jobs, growth and scientific breakthroughs Page summary: European Commissioner for research joins UK Science and Technology Secretary to make joint commitment to maximising UK Horizon Europe success.…
Tehelj
February 21, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 12 Feb)

Please note this is an extract of the original bulletin. Funding for game-changing tech which could destroy cancers and predict disease Page summary: Millions invested in eight innovative companies behind lifesaving new medical technology which could destroy liver cancer tumours, detect Alzheimer’s and quickly spot those at risk of stroke Change made: First published. Medical devices given exceptional use authorisations…
Tehelj
February 21, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Eight innovative technologies selected under IDAP pilot phase

MHRA launched Innovative Devices Access Pathway (IDAP) back in September 2023 to help streamline applications for innovative medical technologies. Today, MHRA have announced that eight innovative medical device technologies are selected for the IDAP. The eight selected innovative devices are: Blood test for Alzheimer’s disease: Roche Diagnostics Ltd has developed an Amyloid Plasma Panel which could help clinicians decide if…
Tehelj
February 14, 2024
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Health Canada: Draft guidance on how to interpret ‘significant change’ of a medical device

This guidance document has been updated to expand on the definition of "significant change" in the Medical Devices Regulations (regulations). This will help you determine whether a change proposed to a Class III or IV medical device is significant. Health Canada have a updated the Guidance on how to interpret ‘significant change’ of a medical device in order to expand…
Tehelj
February 14, 2024
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BSI webinar on the impact of the EU AI Act

BSI are hosting a webinar about updates on the EU AI Act progress, covering its history, the significant elements of the recent December deal, and its potential impact on various industries on 27 February. The webinar will include an explanation on EU AI Act and strategies to prepare for the Act's implementation. Members who are interested in attending this webinar…
Tehelj
February 14, 2024