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After Brexit

Set Alert for Brexit Watch

MHRA's Graeme Tunbridge Joins BSI Notified Body

Graeme Tunbridge is looking forward to a new career with notified body, BSI, after nearly two decades as a civil servant. But where does his departure leave the UK MHRA at a time of critical change?

EU Europe

UK Consultation: Device Regulator Seeks To Balance Innovation And Patient Safety

Innovative device access pathways are on the agenda of both NICE and the MHRA, but the UK regulator’s new chief safety officer stresses that patient safety first and foremost will shape its work programs in the post-EU era.

United Kingdom Regulation

Medtech Industry’s Wishlist For MHRA’s New UK Regulatory Structure

The UK's medtech regulatory consultation has closed and the MHRA must now assess the views of stakeholders on the 465 questions designed to help shape the foundations of a future-proofed regulatory system. But time is tight, as speakers at the ABHI’s annual regulatory conference were at pains to stress.

Regulation United Kingdom

UK’s Ambitious Plan For Medtech Regulation Merits Attention

The MHRA’s efforts to give the UK a nimble, responsive, innovation-facing medtech regulatory system earnt high marks from Bristows’ Alex Denoon, who assessed the opportunity at hand during the MedTech Summit.

United Kingdom Regulation

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
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