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Europe

Set Alert for Policy and Regulation - Europe

German Medtechs Aim To Score Useful Points In 2017 Election Year

The 2017 German national election, set for September 24, is not only a chance for Angela Merkel to secure a fourth term in office as Chancellor, but also an opportunity for the medtech industry to tell lawmakers how they can make the health-care system better. The medtech industry has made ten demands of the new government, with recent opinion polls favoring the status quo.

Germany Medical Device Reimbursement
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Latest From Europe, Policy & Regulation

Medtech Summit: The Three Biggest Challenges Of The EU MDR

The EU's Medical Devices Regulation has entered into force, but there is still three years until it is fully applicable. Already there is a tidal wave of questions about some of the most critical elements. Will they be answered in time?

Europe Medical Device

How Soon Will New Eudamed Database Be Ready? What Are The Hurdles?

The new version of the Eudamed European medical devices database will be a vital component of the EU's new regulatory machinery. But there is a lot of work to do, and the potential for delays. Ronald Boumans, who was involved in setting up the original database and is on the steering committee for the new one, discusses the effort ahead.

Regulation Europe

EU Kicks Off Initiative To Improve Joint Replacement Revision Rates

A key EU standards group is developing a plan to improve safety and reliability of joint replacements, which suffer from high revision rates and wear issues.

Orthopedics Medical Device

EU Standards Bodies' Call For Talks, End To Financial Threat

European standards bodies are reacting to the European Court of Justice recent ruling in a construction-industry case that the groups say could undermine the effectiveness and the financing of EU standards.

Medical Device Europe

EU Court Judgment Challenges Status of Standards: How Will It Hit Medtech?

An EU legal judgment in the construction industry is changing the standards game. Until now, there has not been an official link between standards and EU law. That has changed. But how is medtech affected?

Europe Medical Device

Global Medtech Guidance Tracker: May 2017

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. In the latest update, see documents posted in May 2017.

Regulation Medical Device
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Latest From Europe & Quality Control

'Perfect Storm' Arrives: Clock Ticking For Device Firms To Conform To ISO 13485, MDSAP, EU & ASEAN Regs

Device manufacturers that haven't begun conforming to various ongoing international regulatory changes are behind the 8-ball and risk noncompliance, industry insider Kim Trautman says.

Regulation United States

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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