Ashley Yeo
Healthcare Editor
UK
+21 year(s) experience
Medtech Insight
Germany’s authorities are back on guard against COVID-19 following renewed regional outbreaks. Diagnostics manufacturers will continue to play a strong part in bringing the pandemic substantially under control, a recent industry association virtual conference heard.
Medtech Insight
Although the EU MDR and IVDR will fall outside the scope of new post-Brexit medtech regulations for Great Britain in 2021, the UK MHRA says it has the chance of developing its own world-leading regulatory regime.
Topic Medtech-Brexit Regulation Brexit
Medtech Insight
ABHI director of value and access Luella Trickett talks about the importance of real-world evidence in product development and value-based procurement in secondary care in the UK.
Medtech Insight
Incoming head of diagnostic regulation at the UK ABHI Steve Lee makes a plea for more detailed MHRA guidance around product registration requirements for the post-EU national market.
Topic Medtech-Brexit Regulation
Medtech Insight
High level EU-UK negotiations have yet to deliver a free trade deal. Meanwhile, the MHRA has issued more guidance for medtechs accessing the UK market in 2021.
Topic EU Medtech-Brexit Brexit
Medtech Insight
BVMed says the EU and the UK should set up a system of mutual recognition of medical device regulation to kick in when the UK’s EU exit transition period ends on 31 December.
Topic Medtech-Brexit Regulation Brexit
Medtech Insight
The UK will have new regulatory systems for medical devices in place for when it leaves the EU at the end of this year. The Office for Life Sciences has been fielding more questions from industry on the new structures.
Topic Medtech-Brexit Regulation Brexit
Medtech Insight
Taylor Wessing partner Alison Dennis and MHRA devices regulatory policy manager Gavia Taan provide updates on the UK’s device regulatory plans after the Brexit transition period ends.
Topic Medtech-Brexit Regulation Brexit
Medtech Insight
The UK will have new regulatory systems for medical devices in place for when it leaves the EU at the end of this year. The Office for Life Sciences has been fielding more questions from industry on the new structures.
Topic Medtech-Brexit Regulation Brexit
Medtech Insight
How coronavirus affects IVDs businesses depends on the branch of the industry they are in, a German survey of manufacturers shows. German labs performed one million COVID-19 tests last week.
Topic Coronavirus EU Policy & Regulation
Medtech Insight
Coronavirus has diverted the focus of health systems away from early cancer detection, says a new report by Cancer Research UK, urging a rebalancing of priorities.
Topic Cancer Policy & Regulation
Medtech Insight
New MHRA guidance says the EU CE marking will continue to be used for devices and diagnostics in Great Britain until June 2023, and thereafter a standalone regulatory system will come into place.
Topic Medtech-Brexit Regulation
Medtech Insight
Securing a favorable post-Brexit free trade agreement with the US is the principal aim of the UK’s Department for International Trade, and the UK medtech industry is pressing its case for closer business links with its largest non-EU trading partner.
Medtech Insight
Parliamentary committee meetings on the UK’s devices bill have been postponed as measures to tackle COVID-19 have been moved to center stage.
Medtech Insight
COVID-19 is of no lesser importance to the UK medtech industry, but attention is now refocusing on Brexit, future regulation and trade deals.
Topic EU Medtech-Brexit
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