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After Brexit

Set Alert for Brexit Watch

UK Regulator To Lose 20% Of Staff In Post-Brexit Cost-Cutting Plans

The MHRA intends to drop around 300 roles as it faces a financial crunch after leaving the EU and other pressures.

United Kingdom Brexit

MHRA Must Seize UK Digital And Diagnostics Opportunity: ABHI Perspectives On Enabling Regulation – Part 2

IVD and healthtech industry representatives give their views on how the future UK medtech system can be shaped to be agile and responsive to patients’ needs, mindful that the regulator must deliver a standalone regulatory system and functional UKCA marking in less than two years.

United Kingdom Regulation

MDR Makes EU ‘Much Less Attractive’ For Start-Ups, Says Medtronic EMEA Chief

The fragility of start-ups belies their value in medtech innovation, and they do not need unnecessary regulatory complications.

Europe Regulation

MHRA Chairman Lightfoot Ready To Lead Post-EU Agenda For UK Devices

The UK devices regulator will prioritize innovation, global best practice and enhanced patient safety and the patient voice, MHRA board chairman Stephen Lightfoot said during the ABHI’s spring regulatory conference. New fees for industry are also on the cards.

United Kingdom Regulation

Higher Medtech Regulatory Salaries In The EU, Longer Recruitment Times And A Candidate-Driven Market

There are some golden career opportunities for medtech regulatory candidates right now. In this preview article to a longer interview piece, Elena Kyria of Elemed explains what these are and how firms with open positions can respond.

EU Europe

Fit For The Future: Industry Gets Involved As UK Medtech And Digital Health Care Regulation Reaches Turning Point

The MHRA is in listening mode as it gathers feedback to shape the UKCA marking for medical devices. That, and how the agency precisely will oversee UK device regulation in the future, are front of mind for industry.

United Kingdom Regulation

UK Device Regulatory System Off To Good Start Under ‘Supportive’ MHRA

The UK’s new medical device registration system, one element of the post-Brexit transition being overseen by the MHRA, is going more or less to plan in the early stages of the standstill period.

United Kingdom Regulation

EU Notified Bodies Advise Manufacturers To Think Hard About Regulatory Strategy Timings

Waiting until the grace period expires before making a product application under the EU MDR or IVDR is a gambit that could easily misfire, TEAM-NB warns.

EU Compliance

Complexity And Confusion At The Border As UK Medtech Faces New EU Trading Arrangements

The end of the UK’s Brexit transition was the beginning of its new relationship as a “third country” with the EU.

Trade Policy Policy

UK Government Promise For 2021: No Halting The Advance Of Healthtech Innovation Adoption

There can be no such thing as a COVID dividend, but the renewed digital push and momentum for health system change perhaps come closest.

United Kingdom Policy

UK Medtechs Determined To Exploit Digital Health Opportunity Born From The Pandemic

COVID-19 has forced a rethink in how care should be delivered. Healthcomms Consulting partner Dan Jones says it is an opportunity that must not be squandered.

United Kingdom Policy

Top 20 EU Regulatory Stories Of 2020: Nightmare Year With Brexit, MDR Implementation … And COVID-19

Not only might each day feel like Groundhog Day now – with COVID-19 limiting everyone’s activities. But early 2021 puts the EU medtech sector in a similar place to early 2020. So what has changed?

Europe EU
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