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69 Total results for product and free and sample content found

Medtech Insight

New Device Tax Repeal Bills Are Coming, With Candidate Klobuchar's Help

By Ferdous Al-Faruque 14 Feb 2019

Despite a recent report that Sen. Amy Klobuchar, D-Minn., is backing away from leading efforts to repeal the medical device tax due to her presidential ambitions, sources say she is working with Sen. Pat Toomey, R-Pa., to cosponsor a repeal bill this year. Similarly, on the US House-side, Rep. Ron Kind, D-Wisc., is calling on his colleagues to support a full repeal bill as well.

Topic Medtech

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Medtech Insight

One In Three Medtech Innovators Will Be 'Driven Out Of Business' By EU MDR, German Business Survey Finds

By Ashley Yeo 14 Feb 2019

The EU Medical Device Regulation is 15 months away from being implemented in full, and a new German survey about its potential impact on the medtech innovation and patient-care landscape makes for sobering reading.

Topic Medtech

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Medtech Insight

BSI Touts Very Short Waiting Times For Migrating Certificates From UK To Netherlands

By Amanda Maxwell 07 Feb 2019

With a growing urgency for medtech manufacturers to take decisive action so their products are not banned from the market under an increasingly likely no-deal Brexit, clients of BSI will be relieved to hear their notified body believes time is on their side.

Topic Medtech

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Medtech Insight

EU Beats Predicted Timelines And Appoints First UK Notified Body Against MDRl

By Amanda Maxwell 23 Jan 2019

There had been warnings that the first notified bodies would not be designated by the European Commission until late July 2019, 10 months before the full application of the EU Medical Device Regulation. But now that BSI is the first notified body in the EU to be designated under the MDR, are things looking up?

Topic Medtech

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Medtech Insight

NZ To Replace Outdated And Piecemeal Device Rules

16 Jan 2019

There are significant changes in store for New Zealand’s medical device sector, including a new regulator and a set of pre- and post-market regulatory controls.

Topic Medtech

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Medtech Insight

Global Approvals Infographic

07 Jan 2019

Meddevicetracker recorded 62 medical device approvals from outside the United States in the first quarter for 2018, including 46 CE Marks from Europe.

Topic Medtech

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Medtech Insight

EU Regulatory Roundup November 2018

By Amanda Maxwell 05 Dec 2018

The medtech sector was already quite overwhelmed with the new EU regulations and Brexit uncertainties. Now add into the mix the impact of the global journalistic Implant Files investigation.

Topic Brexit Medtech

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Medtech Insight

Commissioner Says EU MDR/IVDR Implementation 'On Track,' But Fails To Convince Parliament

By Amanda Maxwell 31 Oct 2018

Elżbieta Bieńkowska, a European Commissioner,  is "realistic and confident" when it comes to the implementation of the new EU medtech regulations. She says everything is going to plan. But that is not what members of the European Parliament are hearing.

Topic Medtech

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Medtech Insight

US FDA Shelves Proposal To Mandate Home-Use Device E-Labeling

By David Filmore 18 Oct 2018

A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.

Topic Medtech

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