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Set Alert for Policy and Regulation - Europe

Emerging Markets Welcome Rise Of Robots, But UK Skeptical

New research from Pricewaterhouse Coopers finds that emerging economies are more willing to embrace the use of AI and robotics in health care, compared to Western European countries. The report – "What Doctor? Why AI and Robotics Will Define New Health" – surveyed more than 11,000 people from 12 countries across Europe, the Middle East and Africa. Among these countries, the UK proved to be the biggest skeptic.

Innovation Market Access Commercial

Latest From Europe, Policy &Regulation

Webinar: What's Ahead For IVD Regulations In The EU And US

In this hour-long webinar, Medtech Insight's Amanda Maxwell and David Filmore, and In Vivo's Ashley Yeo discuss regulatory reforms in the works for in vitro diagnostics in the EU and US.

In Vitro Diagnostics Regulation

What's In the Official Journal Of The EU? Fake News?

A text has appeared in the Official Journal of the EU that is raising some questions over whether the new EU regulations are in the process of being officially published, an action which would trigger the countdown to them taking effect.

In Vitro Diagnostics Medical Device

MedTech Europe's John Brennan Moves On At Critical Time For Industry

After nearly nine years, MedTech Europe's John Brennan is leaving the medical device and diagnostics trade association. This is a particularly critical time for the industry body and its members, so what has tempted him away at this specific juncture?

Appointments Europe

New EU Regs Will Offer No Reprieve From Borderline Classification Chaos

Challenges will persist for borderline and combination products under the new EU regulatory structure so manufacturers need to continue to pay close attention when determining the classification of these products.

Combination Products Europe

New Bodies To Emerge Under Revised EU Governance Structure

What is the governance structure under the forthcoming new EU Medical Device and IVD Regulations? Here, Medtech Insight attempts to answer that question and explain how the different organizations and groups relate.

Europe Regulation

Industry Sees Much To Improve In Germany's New High-Risk Medtech Assessment Scheme

Only two of eight treatments passed muster under Germany's new NUBs scheme for assessing the benefit of high-risk products for inpatient use. As with the country's outpatient assessment counterpart, industry is pushing for changes.

Germany Health Technology Assessment
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Latest From Europe &Quality Control

EU Notified Bodies Prepare For En Masse Redesignation

Members of the TEAM-NB association, which account for about half of the anticipated future force of EU medtech notified bodies, are taking a coordinated approach to applying for redesignations against the new EU Medical Device and IVD Regulations. Will they succeed?

Regulation Europe

An Auditor's Take: Unrealistic EU Demands Are Causing Notified Body Exodus, Potential Company Collapses

Demands related to auditor education, experience and affiliation are making it difficult for notified bodies to retain and hire staff. This comes on top of much tougher regulatory requirements. One notified body auditor explains why the situation might be killing notified bodies when they are needed most.

Regulation Europe

Europe – Are You Ready For Unique Device Identification?

Europe-based device companies should look to the experience of the implementation of Unique Device Identification in the US to prepare for the upcoming UDI mandate in the EU, Steve Cottrell and Madris Tomes explain in this guest column.

Regulation Europe

Warning Letter Roundup & Recap – Aug. 16, 2016

FDA finds QS and marketing violations at a host of international device-makers. FDA released warning letters to 14 device companies this week.

Policy & Regulation Quality Control
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