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Guidance

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Global Medtech Guidance Tracker: July 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-nine documents have been posted on the tracker since its last update.

Guidance Documents Regulation

Uncle Sam Is Searching For A Few Good Health IT Advisors

Experts representing manufacturers, patients, providers and federal agencies are being sought by the US government to advise the Office of National Coordinator for Health Information Technology on issues such as health IT standards and specifications.

Policy Digital Health

EMA Finalizes Quality Requirements For Drug-Device Combinations

New EU guidance discusses the quality documentation needed for medicines that contain a device component for their delivery or use.

Europe Guidance Documents

First Harmonized Standards Published For Both MDR And IVDR

After a long delay, the EU’s first harmonized standards under the MDR and IVDR are trickling through ̶ but the standards situation is still far from ideal.

EU Europe

Device Week, 16 July 2021 – An Inside Look At The EU’s Sweeping New Device Regs

In this week’s podcast, EU regulatory editor Amanda Maxwell walks us through the latest news and documents coming out of the European Union’s efforts to revamp its medical device and diagnostics rules and makes some predictions about what we can expect to see going forward.

Device Week Regulation

After 5 Years Of Waiting, FDA Finally Finalizes Guidance On Constructing Unique Device Identifiers

The eight-page guidance document from the US FDA is a handy manual for device makers as they work to meet the agency’s UDI requirements.

Guidance Documents FDA

Global Medtech Guidance Tracker: June 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-six documents have been posted on the tracker since its last update.

Guidance Documents Regulation

FDA’s Draft QSR: ‘Lucy’ Pulled The Football Away. Again

Hopes were raised in mid-June when the US FDA indicated it would release its draft harmonized Quality System Regulation by the end of the month. But perhaps unsurprisingly, it never came. News about the QSR – and more – topped our list of most-read Medtech Insight articles in June.

United States Regulation
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