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Experts: MDR Draft Guidance Compiles Advice, Seeks More Info From Firms

 
• By Shawn M. Schmitt

While much of the information found in FDA’s new 47-page draft guidance for Medical Device Reporting can be found in the MDR regulation, it nevertheless compiles a wealth of advice that the agency has doled out over a number of years.

While much of the information found in FDA’s new 47-page draft guidance

for Medical Device Reporting can be found in the MDR regulation, it nevertheless compiles a wealth of advice that the...

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More from Regulation

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 
• By Natasha Barrow

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

Scores Of Companies On Board With Medicare Data Interoperability And Digital Health Initiative

 
• By Brian Bossetta

The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.

Why EU Notified Bodies Need To Alter The Way They Work

 
• By Amanda Maxwell

Without change, the implementation of the MDR and IVDR could hit another wall.

J&J MedTech’s Digital Head Pushes For Smarter, Standardized ORs With AI And Open Tech

 
• By Marion Webb

J&J’s global head of MedTech Digital envisions AI-powered connected operating suites within a decade. In an interview with Medtech Insight, Shan Jegatheeswaran discusses how J&J, together with partners like NVIDIA and AWS, is laying the foundation for open platforms for standardized surgeries.

More from Policy & Regulation

Trump Taps Food And Drug Law Outsider For FDA Chief Counsel

 
• By Sarah Karlin-Smith

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

US Puts 15% Tariff On EU Exports But Medtechs Push ‘Zero For Zero’

 
• By Ashley Yeo

The US’ foreign trading partners are not working hard enough to secure bilateral deals, says US President Donald Trump, who will introduce new reciprocal tariffs on Aug. 7. MedTech Europe stresses that patients will suffer if medtech is not excluded from the tariffs.

Additional Death And Injuries Added To 2024 Philips Ventilator Recall

 
• By Brian Bossetta

Philips Respironics has updated instructions for use for three ventilators that were included in a May 2024 recall. The company also added three potential injuries and one death to the original number.