Medtech Regulatory News
UK government accepts proposals to tackle bias in medical devices
The UK government has accepted recommendations from a UK-first independent review to tackle potential bias in the design and use of medical devices. Read more
11 Mar 2024
Survey suggests over a third have no understanding of AI regulations
A survey on emerging AI regulations from The Pistoia Alliance showed that just 9% of respondents said they know EU and US AI regulations well, with more than a third (35%) having no understanding at all. Read more
21 Feb 2024
UK Approved Bodies found Team-AB to aid regulatory understanding
UK Approved Bodies and those undergoing the designation process have announced the foundation of Team-AB. Read more
19 Feb 2024
InnoScot Health to offer personalised guidance for regulatory approval
InnoScot Health will deliver a further three days of free personalised guidance for those looking to achieve regulatory approval for a medical device or in vitro diagnostics (IVD) in the UK and US. Read more
8 Feb 2024
MHRA designates LNE-GMED and Scarlet become Approved Bodies
LNE-GMED and Scarlet have been added been given approved body status by the Medicines and Healthcare Products Regulatory Agency (MHRA). Read more
29 Jan 2024
InnoScot Health welcomes MHRA's regulatory roadmap
InnoScot Health has announced its backing of the new regulatory roadmap released by the MHRA, calling it ‘another important step towards easier navigation of the pathway for getting medical device innovation safely into patients' hands. Read more
29 Jan 2024
Trying to keep pace: Technology and regulation
Fiona Maini, senior director global compliance and strategy at Medidata, a Dassault Systèmes company, outlines the challenges that regulation has with keeping up with technology in 2024. Read more
19 Mar 2024
The impact of the new EU Product Liability Framework on medtech
Ed Turtle and Anushi Amin, associates at law firm Cooley, analyse the new Product Liability Directive which will enter into force in 2024 and apply from 2026. Read more
28 Feb 2024
Why AI act must ensure safety without hampering innovation
Elaine Gemmell, head of regulatory affairs at InnoScot Health, analyses where the new EU AI Act legislation is beneficial and where it must remain flexible. Read more
22 Feb 2024
Setting new standards for wireless medical devices
Ravi Subramaniam, director, Conformity Assessment for IEEE SA, outlines the IEEE’s new standards for wireless medical devices in response to the FDA refusing to accept medical devices and associated systems due to cybersecurity concerns. Read more
19 Feb 2024
How new EU Batteries Regulation may affect UK medical device manufacturers
Sidley Austin’s Josefine Sommer, partner specialising in food, drug and medical device regulation, and Michelle Gandolfo, managing associate, outlines how new European battery regulations may impact medical device manufacturers in the UK. Read more
12 Feb 2024
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Thomas Averre is a Director at Tarleton Communications, a specialist life sciences public relations agency. Read more
Dynamic Therapuetics wins Blavatnik prize for U-RHYTHM technology
Dynamic Therapeutics, a spin-out from the University of Bristol, has today been awarded a Blavantik Prize by QantX, a leading venture capital firm, for its U-RHYTHM technology. Based on over 25 years research, it offers a ‘low-cost’ solution to captu Read more
25 Apr 2024
Guardtech Group strengthen sales team with addition of new GMP Commercial Manager
The Guardtech Group has announced the hiring of Pharmaceuticals specialist John Edwards. Edwards has spent his career working in various roles across the Pharma, Medical Device and Speciality Chemical sectors. Read more
23 Apr 2024
CARB-X funds Scout to develop a low-cost point-of-care diagnostic for STI testing
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award up to 1 million USD to diagnostics and health tech company Scout to demonstrate proof-of-concept and feasibility. Read more
22 Apr 2024
IDA Ireland launches “Where next for MedTech – Key considerations for the factory of the future” report
IDA Ireland, the national development agency responsible for attracting foreign investment to the country, has announced the release of its MedTech whitepaper entitled Where next for MedTech – Key considerations for the factory of the future. Read more
19 Apr 2024
St George’s, University of London partners with Tachmed to accelerate new at-home digital diagnostics
Leading specialists in infection diagnostics at St George’s, University of London have partnered with Tachmed to accelerate the development of its first in market, affordable diagnostics that are connected digitally for use in the home. Read more
17 Apr 2024
26 Apr 2024
Women in STEM: Paving the way for innovation in women’s health
Sarah Knight, head of healthcare technology at 42 Technology (42T), argues that until more women can be encouraged to pursue engineering and design as a career, then the full potential of innovation in women’s health will never be realised. Read more
26 Apr 2024
Changing women’s health: Can storytelling heal the system?
Olivia Dias, digital designer at creative agency Driftime, explains why founder stories and connecting with audiences across digital touchpoints are essential for FemTech success. Read more
23 Apr 2024
FemTech: The destigmatisation in the industry
Josephine Ornago, owner at OutspokenPR, creates a four-part series to raise awareness for the femtech market. This series starts with the critical issue of the destigmatisation of the female reproductive apparatus in its entirety. Read more
17 Apr 2024
NHS is ‘frittering away’ huge sums on poor purchasing decisions
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications looks at the impact of delays in the introduction of value-based procurement. Read more
2 Apr 2024
Back to the future?
Ian Bolland reflects on the start of the year in medical technology in the UK, and bids farewell. Read more
15 Mar 2024
Why Live Data is behind successful NHS engagement
Oli Hudson, content director at Wilmington Healthcare, explores why smart, accessible and accurate NHS customer data is vital for UK medtech. Read more
11 Mar 2024
Harnessing wearable technology for real-world data
Claude Price, vice president and head of clinical data management at Quanticate explains the fundamental use of wearables for collecting real-world data, especially in clinical trials. Read more
4 Mar 2024
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What are you waiting for?
Thomas Averre is a Director at Tarleton Communications, a specialist life sciences public relations agency. Read more
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Sponsored
What are you waiting for?
Thomas Averre is a Director at Tarleton Communications, a specialist life sciences public relations agency. Read more
Sponsored
What are you waiting for?
Thomas Averre is a Director at Tarleton Communications, a specialist life sciences public relations agency. Read more
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