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Tag: EU

Your Questions about the EU MDR, Answered

Posted on February 27th 2020

On January 31, 2020, the United Kingdom left the European Union. And in May of 2020, the European Union will introduce the new EU MDR (Medical Device Regulations), which will modernize the process by which medical devices come to market. So for those who market or manufacture medical devices in the EU, this string of changes might seem confusing. Don’t worry; here, we’ll answer your biggest questions about the new EU MDR.  

Published in MultiPoint Blog

Does your company manufacture or market medical devices in the European Union? Then you’re probably aware of the upcoming implementation of the EU Medical Device Regulations in May of 2020。 And for IVD manufacturers, the new In Vitro Diagnostics Regulation goes into effect May of 2022。 But whether you have four months or two years to prepare, you must be educated on the new regulations, which will modernize the processes by which medical devices and IVDs come to market。

Published in MultiPoint Blog

The European Union’s Radio Equipment Directive (RED), which delineates essential requirements for all radio equipment marketed in the EU, was revised in 2014 to adapt to technological changes propelled by IoT。 The directive was revised to include all receivers, all equipment that transmitted and received data, such as kitchen appliances that could receive data from mobile phones。 Despite providing clarity on technical jargon and the role of Notified Bodies, the 2014/53/EU (RED) does not clearly discuss product and software security。 Here’s what you need to know about the security of products that fall under the 2014/53/EU (RED)。

Published in MultiPoint Blog

In the past several years, many changes have been made to the regulations and rules governing the medical device industry—and there are still more to come。

While regulatory changes are not entirely worrisome to larger manufacturing companies, smaller companies who have fewer funds and resources often find it difficult to adapt to regulatory changes。 As new and revised regulatory standards loom before us, it is in these smaller companies’ best interests to prepare for the coming changes。

Published in MultiPoint Blog

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