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13 Total results for product and free and sample content found

Medtech Insight

Interview: ‘More Forward Thinking’ Needed For UK IVD Industry As Brexit Looms

Interview: ‘More Forward Thinking’ Needed For UK IVD Industry As Brexit Looms

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

50 Days To Brexit – And No Extension, Govt Warns UK Medtechs

50 Days To Brexit – And No Extension, Govt Warns UK Medtechs

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

Not Too Late? German Industry Presses For EU MRA With Post-Brexit UK

Not Too Late? German Industry Presses For EU MRA With Post-Brexit UK

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

UK Updates Medtech Industry On National Regulatory System Progress

UK Updates Medtech Industry On National Regulatory System Progress

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

The Politics And The Practice Of UK Standalone Devices Regulation

The Politics And The Practice Of UK Standalone Devices Regulation

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

UK Updates Medtech Industry On National Regulatory System Progress

UK Updates Medtech Industry On National Regulatory System Progress

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

UKCA Mark Will Be The Post-EU Route To The British Medtech Market In January 2021

UKCA Mark Will Be The Post-EU Route To The British Medtech Market In January 2021

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

Brexit Response: Patient Safety Prioritized In Forthcoming UK MHRA Device Regulatory System

Brexit Response: Patient Safety Prioritized In Forthcoming UK MHRA Device Regulatory System

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

All About Value – Brexit Aside, UK Industry Sees Good Things Ahead For Healthtech Adoption

MTI Brexit

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.

Topic Medtech-Brexit EU Legislation Regulation

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