Search Results for medical device regulation

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6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation By Paul Brooks - Published 15 June 2017

When the EU’s new Medical Devices Regulation (MDR) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready.

Categories: Europe, EC, Medical Devices

Tags: Europe MDR, medical device regulation, new device regulations in Europe

MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU By Rod Ruston - Published 03 March 2017

This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR.

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices, Submission and registration

Tags: Medical Device Regulation, In Vitro Diagnostic Medical Devices Regulation, MDR, IVDR

FDA Declares ‘General Wellness’ Devices Exempt From Regulations By Michael Mezher - Published 28 July 2016

The US Food and Drug Administration (FDA) on Thursday finalized guidance saying that it does not plan to review low-risk "general wellness products", such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements.

Categories: News, US, FDA, Government affairs, Medical Devices, Postmarket surveillance, Submission and registration

Tags: medical device regulation, health apps, mobile medical apps, mhealth, exercise equipment and FDA

This Week in Medical Device Regulation (17-21 November 2014) By Alexander Gaffney, RAC - Published 23 November 2014

Welcome to This Week in Medical Device Regulation, your weekly review of regulatory news and intelligence.

Categories: News, Medical Devices, Regulatory intelligence

Tags: This Week in Medical Device Regulation, Medical Device Regulation, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

This Week in Medical Device Regulation (10-14 November 2014) Published 16 November 2014

Welcome to This Week in Medical Device Regulation, your weekly review of regulatory news and intelligence.

Categories: News, Medical Devices, Regulatory intelligence

Tags: This Week in Medical Device Regulation, Medical Device Regulation, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

This Week in Medical Device Regulation (3-7 November 2014) By Alexander Gaffney, RAC - Published 07 November 2014

Welcome to This Week in Medical Device Regulation, your weekly review of regulatory news and intelligence.

Categories: News, In vitro diagnostics, Medical Devices, Regulatory intelligence

Tags: This Week in Medical Device Regulation, Medical Device Regulation, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

China Announces Major Overhaul of Device Regulation By Louise Zornoza, RegLink - Published 02 April 2014

Categories: Regulatory Update, China, CFDA

Tags: Medical Device Regulation, Class, GMP, medical device