Regulatory News Medical Devices

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Medical Devices News and Events | FDA

https://www.fda.gov/medical-devices/medical-devices-news-and-events

January 10, 2023 CDRH Statements - Statements from the Center for Devices and Radiological Health (CDRH), as we discuss significant steps towards continuing to …

CDRHNew - News and Updates | FDA

https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrhnew-news-and-updates

Federal Register: Gastroenterology-Urology Devices; Classification of the Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal …

Medical Device News | MedTech Dive

https://www.medtechdive.com/topic/medical-devices/

More mergers, new diabetes devices and the road to MDR: Medtech trends in 2023 Medical device leaders expect financial pressures to ease as companies navigate …

Emergo by UL News

https://www.emergobyul.com/news

Regulatory Update Jan 31, 2023 US FDA and Health Canada Launch eSTAR Pilot The US FDA and Health Canada have announced the launch of their joint eSTAR pilot program, an interactive …

Medtech News | Latest Regulatory News - Med-Tech …

https://www.med-technews.com/news/Medtech-Regulatory-News

Regulation for medical devices: recent developments explained Eamonn McGowran, medical devices regulatory specialist and associate director at global drug …

Medical Device Regulation comes into application

https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application

The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new …

Medical Devices - Sector - Latest updates - Public Health

https://health.ec.europa.eu/medical-devices-sector/latest-updates_en

News announcement 16 December 2022 MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - …

Regulatory Focus™ | RAPS

https://www.raps.org/news-and-articles

The European Parliament on Thursday voted overwhelmingly to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving products in the …

Regulatory strategy for medical devices approval

https://www.news-medical.net/whitepaper/20220826/Regulatory-strategy-for-medical-devices-approval.aspx

When it comes to medical device regulatory strategy, three major factors can lead to delays in acquiring approval to market in any country. They are as follows: …

EU MDR Newsletter - Medical Device Regulation …

https://www.regulatoryglobe.com/medical-device-news/

MDCG 2021-4: Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 – Link April 9, …

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